Acute on Chronic Hypercapnic Respiratory FailureNCT04317326
"Post-acute Pickwick Study" (Postacute-Pick-2020)
A study testing Automatic NIV, CPAP treatment group and NIV treatment groups in people with Acute on Chronic Hypercapnic Respiratory Failure and Obesity Hypoventilation Syndrome (OHS), run by Juan F. Masa.
Trial summary
We propose to carry out a large multicentric, multinational, randomized controlled trial with two phases (two sequential randomized controled trials) to answer two questions: 1) Should hospitalized patients with recently diagnosed OHS be discharged from the hospital on an auto-titratable NIV treatment until the… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute on Chronic Hypercapnic Respiratory Failure, Obesity Hypoventilation Syndrome (OHS)
- What is being tested?
- Automatic NIV, CPAP treatment group and NIV treatment groups
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2023to Dec 2029
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- º.- Patient between 18 and 85 years old.
- º.- With diagnosis of OHS (according to Obesity (BMI ≥30 kg/m2) and Hypercapnic respiratory failure (PaCO2 ≥45 mmHg at hospital discharge) not secondary to other causes.
- º - Hospitalized for an episode of acute-on-chronic hypercapnic respiratory failure, receiving hospital therapy with invasive or noninvasive ventilation, and just deemed stable for home discharge."
- º.- No NIV or CPAP home therapy in the last 6 months[*].
- º.- Being able to tolerate and correctly execute a 15-minute test with automatic NIV (AVAPS-AE) and another 15-minute test with fixed CPAP treatments during wakefulness.
- º.- Providing informed consent (dated and signed).
- [] Patients who have objective evidence of minimal PAP therapy during the 6 months prior to hospital admission (i.e. average daily use of less than 2 hours of PAP therapy) can also be enrolled at the discretion of the investigators if they feel the patient is now more interested in being adherent to NIV therapy.
- 1º.- Included three months ago in the first phase of the study (followed by a washout period of 5 days).
Who cannot join
- º.- With moderate or severe chronic obstructive pulmonary disease (FEV1<70% of predicted when FEV1/FVC is below 70%).
- º.- With neuromuscular disease, thoracic wall or metabolic disease that may cause diurnal hypercapnia.
- º.- Inability to maintain a patent airway or adequately clear secretions.
- º.- With bullous lung disease or with pneumothorax.
- º.- With bypassed upper airway (i.e. endotracheal tube or tracheostomy).
- º.- With anatomical abnormalities of the craniofacial structure leading to cerebral spinal fluid leaks, abnormalities of the cribriform plate, and/or pneumocephalus.
Show all 21Show fewer
- º.- At risk for aspiration of gastric contents.
- º.- Diagnosed with acute sinusitis or otitis media.
- º.- With active hemoptysis or epistaxis if presenting a risk of causing pulmonary aspiration of blood.
- º.- With symptomatic hypotension.
- º.- With clinical diagnosis of narcolepsy or restless leg syndrome.
- º.- Psycho-physical incapacity to complete questionnaires.
- º.- With diagnosis of chronic illness that might interfere the evaluation using quality of life questionnaires (neoplasia, severe chronic pain of any type, and any other severe chronic debilitating illness).
- º.- Suffering other clinically relevant disease that, under the opinion of the investigator, might affect the evaluations of efficacy or safety.
- º.- Participating simultaneously in other clinical study with intervention (or without intervention at the discretion of the investigator and with the consent of the Sponsor) or had participated in other clinical study with intervention within the last 30 days before the inclusion in this study. [‡]
- º.- If for any reason (planned surgery [including bariatric surgery], trips of long duration, etc.) would not be able to receive the treatment and/or attend the follow-up visits of this study within the next three years and three months.
- º.- Persons deprived of liberty by judicial or administrative decision, persons under psychiatric treatment and persons placed in a health or social institution for purposes other than those of this clinical study.
- º.- Adults who are subject to a legal protection measure or who are unable to express their consent.
- [‡] This prohibition shall be maintained for the duration of the patients' participation in the study. This is because, if patients received other treatments, it could be difficult to interpret the causality of the results obtained (whether beneficial or harmful effects) and the possible contraindications.
- Exclusion criteria for the second phase of the study:
- 1º.- With apnea hypopnea index (AHI) lower than 5 (absence or very mild obstructive sleep apnea).
About this study
Official title: "Mid- and Long-term Effectiveness of Positive Airway Pressure in OHS After an Acute-on-chronic Hypercapnic Respiratory Failure"
We propose to carry out a large multicentric, multinational, randomized controlled trial with two phases (two sequential randomized controled trials) to answer two questions: 1) Should hospitalized patients with recently diagnosed OHS be discharged from the hospital on an auto-titratable NIV treatment until the diagnosis of OHS is confirmed in 3 months? 2) Is the long-term effectiveness of outpatient titrated CPAP non-inferior to titrated NIV in ambulatory patients with OHS 3 months after hospital discharge? Clinical practice, multicenter open-label controlled randomized clinical trial with preset allocation rate (1:1) with two parallel-groups conducted in centers from Spain, France, Portugal and USA. The study will have two phases with two randomizations. The first phase will be a superiority study and the second phase will be a non-inferiority study.
Read the detailed description
Objectives: First phase (medium-term): To evaluate the medium-term (3 months) efficacy of automatically adjusted noninvasive ventilation (NIV) treatment versus "life style modifications" treatment in obesity hypoventilation syndrome (OHS) after an episode of acute-on-chronic hypercapnic respiratory failure. The main outcome will be a composite that includes hospital resource utilization (hospital and ICU admissions and emergency department visits for any cause) and all-cause mortality. Key secondary outcomes will include incident cardiovascular events (new hypertension diagnosis or initiation of anti-hypertensive treatment, atrial fibrillation, hospitalization for nonfatal myocardial infarction or unstable angina, percutaneous coronary interventions, nonfatal stroke or transient ischemic attack or for acute heart failure episode, and cardiovascular death), blood pressure, arterial blood gases, clinical symptoms and quality of life. Second phase (long-term): Evaluate the long-term efficacy (36 months) of manually titrated NIV treatment versus manually titrated CPAP treatment in OHS after 3 months of an episode of acute-on-chronic hypercapnic respiratory failure, with a composite outcome of hospital resource utilization (hospital and ICU admissions, emergency department visits) and all-cause mortality analyzed as the primary outcome. Incident cardiovascular events, blood pressure, arterial blood gases, clinical symptoms and quality of life will be the main secondary outcomes.
Methods: Prospective, multinational, randomized open-label controlled trial with two parallel arms: 1,110 hospitalized patients with newly diagnosed OHS with acute-on-chronic hypercapnic respiratory failure treated with invasive or noninvasive mechanical ventilation who survive hospitalization and available for hospital discharge will be randomized to either automatically adjusted NIV (555 patients) or "life style modifications" (555 patients) for three months. Subsequently, both automatically adjusted NIV and "life style modifications" arms will be re-randomized to polysomnographically adjusted CPAP or to polysomnographically adjusted NIV groups to complete 36 months of follow up. The first phase of the proposal is a superiority study and the second phase is a non-inferiority study. The primary outcome and its components will be analyzed by a mixed-effects model with negative binomial. A mixed-effects Cox model will be used for hospital resource utilization, new cardiovascular events and overall survival. Other secondary outcomes such as repeated measures derived from the arterial blood gases (i.e. PaCO2, PaO2, pH, calculated bicarbonate), blood pressure, health-related quality of life tests and Epworth Sleepiness Scale during the follow-up will be analyzed by a linear mixed-effects model.
- Being tested
- "Lifestyle modifications" group (Control), Automatic NIV, CPAP treatment group, NIV treatment groups
- Keywords
- Hypercapnic respiratory failure, Obesity, Non invasive mechanical ventilation, CPAP
- Medical subject headings
- Obesity Hypoventilation Syndrome, Respiratory Insufficiency, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Lifestyle modifications" group (Control)Procedure or surgery
It will consist of a 1,000-calorie/day diet and to maintain proper sleep hygiene and habits (avoid supine decubitus position, maintain regular sleep habits and exercise, not take sedatives, stimulants, alcohol, tobacco or heavy meals within four hours before bedtime). Oxygen therapy can be prescribed by the treating team using standard criteria (awake PaO2 <55 mmHg or room air oxygen saturation below 88% (Masa JF et al. J Clin Sleep Med. 2016 ;12:1379-88). The treatment period will be three months.
Automatic NIVProcedure or surgery
In addition to lifestyle modification and oxygen (if required), the ventilator will be adjusted to a range of predetermined parameters with the intelligent ventilation mode (pressure of intelligent support with guaranteed volume with automatic backup frequency) with the following adjustment: maximum pressure: 35 cmH2O; respiratory rate: automatic; maximum pressure support: 18 cm H2O; minimum pressure support: 4 cmH2O; maximum EPAP pressure: 15 cmH2O; minimum EPAP pressure: 4 cmH2O; and tidal volume (Vt) based on 8-10 ml/kg of predicted body weight, being able to be modified according to tolerance.The treatment period will be three months.
CPAP treatment groupProcedure or surgery
In-laboratory polysomnographic CPAP titration will be performed according to published guidelines for CPAP titration (SEPAR guideline or AASM guideline).In addition to lifestyle modification and oxygen (if require), a home titrated CPAP therapy will be initiated.The treatment period will be three years.
NIV treatment groupsProcedure or surgery
In-laboratory polysomnographic NIV titration will be performed according to published guidelines In addition to lifestyle modification and oxygen (if required) home NIV therapy with fixed pressures will be started. The ventilator mode will be a bilevel pressure in S/T mode. The ventilator adjustment will be firstly performed in awake situation and then during sleep by means of a PSG. The treatment period will be three years.
| Study group | Role | What they receive |
|---|---|---|
| Life style modification | Experimental | "Lifestyle modifications" group (Control) will consist of a 1,000-calorie/day diet and to maintain proper sleep hygiene and habits (avoid supine decubitus position, maintain regular sleep habits and exercise, not take sedatives, stimulants, alcohol, tobacco or heavy meals within four hours before bedtime). Oxygen therapy can be prescribed by the treating team using standard criteria (awake PaO2 <55 mmHg or room air oxygen saturation below 88% (Masa JF et al. J Clin Sleep Med. 2016 ;12:1379-88) Receives: Procedure: "Lifestyle modifications" group (Control) |
| Life style modificacion and automatic NIV(AVAPS-AE) | Active comparator | Automatic NIV: In addition to lifestyle modification and oxygen (if required), the ventilator will be adjusted to a range of predetermined parameters with the intelligent ventilation mode (pressure of intelligent support with guaranteed volume with automatic backup frequency) with the following adjustment: maximum pressure: 35 cmH2O; respiratory rate: automatic; maximum pressure support: 20 cm H2O; minimum pressure support: 4 cmH2O; maximum EPAP pressure: 15 cmH2O; minimum EPAP pressure: 4 cmH2O; and tidal volume (Vt) based on 8-10 ml/kg of predicted body weight. These parameters may be modified according to patient tolerance or non-compensated leak. Receives: Procedure: Automatic NIV |
| Life style modification and titrated NIV(S/T mode) | Experimental | In-laboratory polysomnographic NIV titration will be performed according to published guidelines (Berry R et al JCSM 2010). In addition to lifestyle modification and oxygen (if required), home NIV therapy with fixed pressures will be started. The ventilator mode will be a bilevel PAP with backup respiratory rate (BIPAP S/T mode). The ventilator adjustment will be firstly performed in awake situation and then during sleep by means of a PSG. Receives: Procedure: CPAP treatment group |
| Life style modification and titrated CPAP | Active comparator | In-laboratory polysomnographic CPAP titration will be performed according to published guidelines (SEPAR guideline or AASM guideline). In addition to lifestyle modification and oxygen (if required), home CPAP therapy at a fixed pressure will be initiated. Receives: Procedure: NIV treatment groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medium-term composite hospital resource utilization-mortality
Primary (medium-term from the first phase or RCT): the medium-term efficacy of automatic NIV treatment versus "lifestyle modifications" treatment in OHS measuring as primary outcome a composite including hospital and ICU admissions, emergency department visits for any cause, and all-cause mortality measured as the number of events
Measured: 3 months
Long-term composite hospital resource utilization-mortality
Primary (long-term from the second phase or RCT): the long-term efficacy of titrated CPAP therapy versus titrated NIV therapy in OHS measuring as primary outcome a composite including hospital and ICU admissions, emergency department visits for any cause, and all-cause mortality measured as the number of events
Measured: 3 years
Secondary outcomes (38)
Hospital admissions
Separately the components of the primary outcome: hospital admissions measured as the number of events
Measured: During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
ICU admissions
Separately the components of the primary outcome: ICU admissions measured as the number of events
Measured: During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Emergency department visits
Separately the components of the primary outcome: emergency department visits for any cause measured as the number of events
Measured: During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
All-cause mortality
Separately the components of the primary outcome: All-cause mortality number
Measured: During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Duration of hospital admissions
Duration of hospital admissions measured in days of hospital admission
Measured: During 3 months and during 3 years for the first and second phase or sequential RCTs respectively
Duration of ICU admissions
Duration of ICU admissions measured in days of ICU admission
Measured: During 3 months and during 3 years for the first and second phase or sequential RCTs respectively
Number of patients who change of the allocated arms
Number of patients who change of the allocated arms
Measured: During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Causes of change of the allocated treatment
Causes of change of the allocated arms
Measured: During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Clinical symptoms: lower extremity edema
Number of patients into four levels of frequency (no, sometimes, usually and always)
Measured: During 3 months and during 3 years for first and second phases or sequential RCTs respectively
Clinical symptoms: unrefreshing sleep
Number of patients into four levels of frequency (no, sometimes, usually and always)
Measured: During 3 months and during 3 years for first and second phases or sequential RCTs respectively
Clinical symptoms: morning fatigue
Number of patients into four levels of frequency (no, sometimes, usually and always)
Measured: During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Clinical symptoms: nocturia
Number of patients into four levels of frequency (no, sometimes, usually and always)
Measured: During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Clinical symptoms: headache
Number of patients into four levels of frequency (no, sometimes, usually and always)
Measured: During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Clinical symptoms: tiredness
Number of patients into four levels of frequency (no, sometimes, usually and always)
Measured: During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Clinical symptoms: morning confusion
Number of patients into four levels of frequency (no, sometimes, usually and always)
Measured: During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Clinical symptoms: dysnea
Number of patients with dysnea according to the Medical Research Council scale classified into five levels of intensity (from 0 to 4)
Measured: During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Clinical symptoms: sleepiness
Level of perceived sleepiness measured by the Epworth Sleepiness Scale
Measured: During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Health related quality of life (HRQL): Functional Outcomes of Sleep Questionnaire-- FOSQ--
Scoring of Functional Outcomes of Sleep Questionnaire-- FOSQ---
Measured: During 3 months and during 3 years for first and second phases or sequential RCTs respectively
Health related quality of life (HRQL): European health-related quality of life questionnaire (EuroQol) EQ-5D-5L
Scoring of European health-related quality of life questionnaire (EuroQol) EQ-5D-5L
Measured: During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Health related quality of life (HRQL): Subjective state of illness on a visual analogical scale: Visual Analogical Well-being Scale -VAWS (Masa JF et al. Sleep Breath. 2011;15:549-59) (EuroQol) EQ-5D-5L
Scoring of Subjective state of illness on a visual analogical scale: Visual Analogical Well-being Scale -VAWS (Masa JF et al. Sleep Breath. 2011;15:549-59) measured in percentage.
Measured: During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Arterial blood gases (ABG): PaO2
PaO2 in mmHg
Measured: During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Arterial blood gases (ABG): PaCO2
PaCO2 in mmHg
Measured: During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Arterial blood gases (ABG): Bicarbonate
bicarbonate measured in mmol/L
Measured: During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Arterial blood gases (ABG): pH
pH
Measured: During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Weight
weight in Kg
Measured: During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Standardized blood pressure measures
Systolic and diastolic blood pressure measured in mmHg
Measured: During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Incidence of cardiovascular events: systemic hypertension
Incidence of hypertension diagnosis or initiation of a new anti-hypertensive treatment
Measured: During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Incidence of cardiovascular events: arrhythmia
Incidence of arrhythmia
Measured: During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Incidence of cardiovascular events: nonfatal myocardial infarction
Incidence of nonfatal myocardial infarction
Measured: During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Incidence of cardiovascular events: hospitalization for unstable angina
Incidence of hospitalization for unstable angina
Measured: During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Incidence of cardiovascular events: coronary percutaneous interventions
Incidence of coronary percutaneous interventions
Measured: After 3 months and after 3 years for first and second phases or sequential RCTs respectively
Incidence of cardiovascular events: nonfatal stroke or transient ischemic attack
Incidence of nonfatal stroke or transient ischemic attack
Measured: During 3 months and during 3 years for first and second phases or sequential RCTs respectively
Incidence of cardiovascular events: heart failure episode
Incidence of heart failure episode
Measured: During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Incidence of cardiovascular events: cardiovascular death
Incidence of cardiovascular death.
Measured: During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Incidence of adverse event
Number of adverse events according to Treatment-Related Adverse Events as assessed by CTCAE v5.0
Measured: During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Cost-effectiveness analysis based on the primary outcome and quality adjusted life year (QALY)
Differences in within trial costs will be related with the differences in effectiveness (primary outcome and QALY) between arms using a probabilistic approach to calculate the cost-effectiveness plane.
Measured: During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Number of oro-tracheal intubation
Number of the tracheal intubations
Measured: During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Duration of tracheal intubation
Duration of tracheal intubation
Measured: During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2020
- Study startJan 2023 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (estimated)
Why it stopped: due to the "Philips alert " we could not get the treatment equipment and the public grands expired
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (35)Papers the sponsor has linked to this study.
- Other trials for Acute on Chronic Hypercapnic Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, open label, randomized controlled trial with two sequential phases
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Juan F. Masa
- Sponsor type
- University, hospital or other
- Collaborators
- Rush University Medical Center
- Responsible party
- Sponsor-investigator, Juan F. Masa, Sociedad Española de Neumología y Cirugía Torácica
- Investigators
- Juan F Masa, MD, Phd, Principal investigator, Servicio Extremeño de SaludBabak Mokhlesi, MD, Prof, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04317326
- Sponsor's protocol ID
- PI19/00955
- Status last verified
- May 2023
- First submitted
- 14 Feb 2020
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Additional related documents such as study protocol, statistical analysis plan, and informed consent form will be available upon request from the Project principal investigator (Dr. Juan Fernando Masa). Deidentified patients' data can be requested by researchers for use in independent scientific research and will be provided following review and approval of the research proposal (including statistical analysis plan) and completion of a data sharing agreement with the Project Publications Committee. Investigator Data requests can be made anytime from 1 to 2 years after the publication of this trial. Requests should be sent to the corresponding author (Dr. Juan Fernando Masa- fmasa@separ.es).
Publications
Storre JH, Seuthe B, Fiechter R, Milioglou S, Dreher M, Sorichter S, Windisch W. Average volume-assured pressure support in obesity hypoventilation: A randomized crossover trial. Chest. 2006 Sep;130(3):815-21. doi: 10.1378/chest.130.3.815.
PubMed 16963680Masa JF, Rubio M, Findley LJ. Habitually sleepy drivers have a high frequency of automobile crashes associated with respiratory disorders during sleep. Am J Respir Crit Care Med. 2000 Oct;162(4 Pt 1):1407-12. doi: 10.1164/ajrccm.162.4.9907019.
PubMed 11029353Teran-Santos J, Jimenez-Gomez A, Cordero-Guevara J. The association between sleep apnea and the risk of traffic accidents. Cooperative Group Burgos-Santander. N Engl J Med. 1999 Mar 18;340(11):847-51. doi: 10.1056/NEJM199903183401104.
PubMed 10080847Marin JM, Carrizo SJ, Vicente E, Agusti AG. Long-term cardiovascular outcomes in men with obstructive sleep apnoea-hypopnoea with or without treatment with continuous positive airway pressure: an observational study. Lancet. 2005 Mar 19-25;365(9464):1046-53. doi: 10.1016/S0140-6736(05)71141-7.
PubMed 15781100Kessler R, Chaouat A, Schinkewitch P, Faller M, Casel S, Krieger J, Weitzenblum E. The obesity-hypoventilation syndrome revisited: a prospective study of 34 consecutive cases. Chest. 2001 Aug;120(2):369-76. doi: 10.1378/chest.120.2.369.
PubMed 11502631Masa JF, Corral J, Alonso ML, Ordax E, Troncoso MF, Gonzalez M, Lopez-Martinez S, Marin JM, Marti S, Diaz-Cambriles T, Chiner E, Aizpuru F, Egea C; Spanish Sleep Network. Efficacy of Different Treatment Alternatives for Obesity Hypoventilation Syndrome. Pickwick Study. Am J Respir Crit Care Med. 2015 Jul 1;192(1):86-95. doi: 10.1164/rccm.201410-1900OC.
PubMed 25915102Castro-Anon O, Perez de Llano LA, De la Fuente Sanchez S, Golpe R, Mendez Marote L, Castro-Castro J, Gonzalez Quintela A. Obesity-hypoventilation syndrome: increased risk of death over sleep apnea syndrome. PLoS One. 2015 Feb 11;10(2):e0117808. doi: 10.1371/journal.pone.0117808. eCollection 2015.
PubMed 25671545Basoglu OK, Tasbakan MS. Comparison of clinical characteristics in patients with obesity hypoventilation syndrome and obese obstructive sleep apnea syndrome: a case-control study. Clin Respir J. 2014 Apr;8(2):167-74. doi: 10.1111/crj.12054. Epub 2013 Nov 28.
PubMed 24028180Priou P, Hamel JF, Person C, Meslier N, Racineux JL, Urban T, Gagnadoux F. Long-term outcome of noninvasive positive pressure ventilation for obesity hypoventilation syndrome. Chest. 2010 Jul;138(1):84-90. doi: 10.1378/chest.09-2472. Epub 2010 Mar 26.
PubMed 20348200Berg G, Delaive K, Manfreda J, Walld R, Kryger MH. The use of health-care resources in obesity-hypoventilation syndrome. Chest. 2001 Aug;120(2):377-83. doi: 10.1378/chest.120.2.377.
PubMed 11502632Corral J, Mogollon MV, Sanchez-Quiroga MA, Gomez de Terreros J, Romero A, Caballero C, Teran-Santos J, Alonso-Alvarez ML, Gomez-Garcia T, Gonzalez M, Lopez-Martinez S, de Lucas P, Marin JM, Romero O, Diaz-Cambriles T, Chiner E, Egea C, Lang RM, Mokhlesi B, Masa JF; Spanish Sleep Network. Echocardiographic changes with non-invasive ventilation and CPAP in obesity hypoventilation syndrome. Thorax. 2018 Apr;73(4):361-368. doi: 10.1136/thoraxjnl-2017-210642. Epub 2017 Nov 16.
PubMed 29146865Masa JF, Corral J, Romero A, Caballero C, Teran-Santos J, Alonso-Alvarez ML, Gomez-Garcia T, Gonzalez M, Lopez-Martin S, De Lucas P, Marin JM, Marti S, Diaz-Cambriles T, Chiner E, Merchan M, Egea C, Obeso A, Mokhlesi B; Spanish Sleep Network( *). Protective Cardiovascular Effect of Sleep Apnea Severity in Obesity Hypoventilation Syndrome. Chest. 2016 Jul;150(1):68-79. doi: 10.1016/j.chest.2016.02.647. Epub 2016 Feb 27.
PubMed 26923627Weitzenblum E, Kessler R, Chaouat A. [Alveolar hypoventilation in the obese: the obesity-hypoventilation syndrome]. Rev Pneumol Clin. 2002 Apr;58(2):83-90. French.
PubMed 12082446Chaouat A, Weitzenblum E, Krieger J, Sforza E, Hammad H, Oswald M, Kessler R. Prognostic value of lung function and pulmonary haemodynamics in OSA patients treated with CPAP. Eur Respir J. 1999 May;13(5):1091-6. doi: 10.1034/j.1399-3003.1999.13e25.x.
PubMed 10414409Biring MS, Lewis MI, Liu JT, Mohsenifar Z. Pulmonary physiologic changes of morbid obesity. Am J Med Sci. 1999 Nov;318(5):293-7. doi: 10.1097/00000441-199911000-00002.
PubMed 10555090
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Mid- and Long-term Effectiveness of Positive Airway Pressure in OHS After an Acute-on-chronic Hypercapnic Respiratory Failure"
- ClinicalTrials.gov ID
- NCT04317326
- Acronym / sponsor ID
- PI19/00955
- Keywords
- Hypercapnic respiratory failure, Obesity, Non invasive mechanical ventilation, CPAP
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: due to the "Philips alert " we could not get the treatment equipment and the public grands expired
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Juan F. MasaUniversity, hospital or other
- Collaborators
- Rush University Medical Center
- Study start
- Jan 2023 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 23 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We propose to carry out a large multicentric, multinational, randomized controlled trial with two phases (two sequential randomized controled trials) to answer two questions: 1) Should hospitalized patients with recently diagnosed OHS be discharged from the hospital on an auto-titratable NIV treatment until the diagnosis of OHS is confirmed in 3 months? 2) Is the long-term effectiveness of outpatient titrated CPAP non-inferior to titrated NIV in ambulatory patients with OHS 3 months after hospital discharge? Clinical practice, multicenter open-label controlled randomized clinical trial with preset allocation rate (1:1) with two parallel-groups conducted in centers from Spain, France, Portugal and USA. The study will have two phases with two randomizations. The first phase will be a superiority study and the second phase will be a non-inferiority study.
Detailed description
Objectives: First phase (medium-term): To evaluate the medium-term (3 months) efficacy of automatically adjusted noninvasive ventilation (NIV) treatment versus "life style modifications" treatment in obesity hypoventilation syndrome (OHS) after an episode of acute-on-chronic hypercapnic respiratory failure. The main outcome will be a composite that includes hospital resource utilization (hospital and ICU admissions and emergency department visits for any cause) and all-cause mortality. Key secondary outcomes will include incident cardiovascular events (new hypertension diagnosis or initiation of anti-hypertensive treatment, atrial fibrillation, hospitalization for nonfatal myocardial infarction or unstable angina, percutaneous coronary interventions, nonfatal stroke or transient ischemic attack or for acute heart failure episode, and cardiovascular death), blood pressure, arterial blood gases, clinical symptoms and quality of life. Second phase (long-term): Evaluate the long-term efficacy (36 months) of manually titrated NIV treatment versus manually titrated CPAP treatment in OHS after 3 months of an episode of acute-on-chronic hypercapnic respiratory failure, with a composite outcome of hospital resource utilization (hospital and ICU admissions, emergency department visits) and all-cause mortality analyzed as the primary outcome. Incident cardiovascular events, blood pressure, arterial blood gases, clinical symptoms and quality of life will be the main secondary outcomes.
Methods: Prospective, multinational, randomized open-label controlled trial with two parallel arms: 1,110 hospitalized patients with newly diagnosed OHS with acute-on-chronic hypercapnic respiratory failure treated with invasive or noninvasive mechanical ventilation who survive hospitalization and available for hospital discharge will be randomized to either automatically adjusted NIV (555 patients) or "life style modifications" (555 patients) for three months. Subsequently, both automatically adjusted NIV and "life style modifications" arms will be re-randomized to polysomnographically adjusted CPAP or to polysomnographically adjusted NIV groups to complete 36 months of follow up. The first phase of the proposal is a superiority study and the second phase is a non-inferiority study. The primary outcome and its components will be analyzed by a mixed-effects model with negative binomial. A mixed-effects Cox model will be used for hospital resource utilization, new cardiovascular events and overall survival. Other secondary outcomes such as repeated measures derived from the arterial blood gases (i.e. PaCO2, PaO2, pH, calculated bicarbonate), blood pressure, health-related quality of life tests and Epworth Sleepiness Scale during the follow-up will be analyzed by a linear mixed-effects model.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Prospective, open label, randomized controlled trial with two sequential phases
| Arm | Type | Receives |
|---|---|---|
| Life style modification | Experimental | Procedure: "Lifestyle modifications" group (Control)"Lifestyle modifications" group (Control) will consist of a 1,000-calorie/day diet and to maintain proper sleep hygiene and habits (avoid supine decubitus position, maintain regular sleep habits and exercise, not take sedatives, stimulants, alcohol, tobacco or heavy meals within four hours before bedtime). Oxygen therapy can be prescribed by the treating team using standard criteria (awake PaO2 <55 mmHg or room air oxygen saturation below 88% (Masa JF et al. J Clin Sleep Med. 2016 ;12:1379-88) |
| Life style modificacion and automatic NIV(AVAPS-AE) | Active comparator | Procedure: Automatic NIVAutomatic NIV: In addition to lifestyle modification and oxygen (if required), the ventilator will be adjusted to a range of predetermined parameters with the intelligent ventilation mode (pressure of intelligent support with guaranteed volume with automatic backup frequency) with the following adjustment: maximum pressure: 35 cmH2O; respiratory rate: automatic; maximum pressure support: 20 cm H2O; minimum pressure support: 4 cmH2O; maximum EPAP pressure: 15 cmH2O; minimum EPAP pressure: 4 cmH2O; and tidal volume (Vt) based on 8-10 ml/kg of predicted body weight. These parameters may be modified according to patient tolerance or non-compensated leak. |
| Life style modification and titrated NIV(S/T mode) | Experimental | Procedure: CPAP treatment groupIn-laboratory polysomnographic NIV titration will be performed according to published guidelines (Berry R et al JCSM 2010). In addition to lifestyle modification and oxygen (if required), home NIV therapy with fixed pressures will be started. The ventilator mode will be a bilevel PAP with backup respiratory rate (BIPAP S/T mode). The ventilator adjustment will be firstly performed in awake situation and then during sleep by means of a PSG. |
| Life style modification and titrated CPAP | Active comparator | Procedure: NIV treatment groupsIn-laboratory polysomnographic CPAP titration will be performed according to published guidelines (SEPAR guideline or AASM guideline). In addition to lifestyle modification and oxygen (if required), home CPAP therapy at a fixed pressure will be initiated. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- º.- Patient between 18 and 85 years old.
- º.- With diagnosis of OHS (according to Obesity (BMI ≥30 kg/m2) and Hypercapnic respiratory failure (PaCO2 ≥45 mmHg at hospital discharge) not secondary to other causes.
- º - Hospitalized for an episode of acute-on-chronic hypercapnic respiratory failure, receiving hospital therapy with invasive or noninvasive ventilation, and just deemed stable for home discharge."
- º.- No NIV or CPAP home therapy in the last 6 months[*].
- º.- Being able to tolerate and correctly execute a 15-minute test with automatic NIV (AVAPS-AE) and another 15-minute test with fixed CPAP treatments during wakefulness.
Key exclusion criteria (21 listed)
- º.- With moderate or severe chronic obstructive pulmonary disease (FEV1<70% of predicted when FEV1/FVC is below 70%).
- º.- With neuromuscular disease, thoracic wall or metabolic disease that may cause diurnal hypercapnia.
- º.- Inability to maintain a patent airway or adequately clear secretions.
- º.- With bullous lung disease or with pneumothorax.
- º.- With bypassed upper airway (i.e. endotracheal tube or tracheostomy).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "Lifestyle modifications" group (Control)It will consist of a 1,000-calorie/day diet and to maintain proper sleep hygiene and habits (avoid supine decubitus position, maintain regular sleep habits and exercise, not take sedatives, stimulants, alcohol, tobacco or heavy meals within four hours before bedtime). Oxygen therapy can be prescribed by the treating team using standard criteria (awake PaO2 <55 mmHg or room air oxygen saturation below 88% (Masa JF et al. J Clin Sleep Med. 2016 ;12:1379-88). The treatment period will be three months. | Procedure or surgery | Life style modification |
| Automatic NIVIn addition to lifestyle modification and oxygen (if required), the ventilator will be adjusted to a range of predetermined parameters with the intelligent ventilation mode (pressure of intelligent support with guaranteed volume with automatic backup frequency) with the following adjustment: maximum pressure: 35 cmH2O; respiratory rate: automatic; maximum pressure support: 18 cm H2O; minimum pressure support: 4 cmH2O; maximum EPAP pressure: 15 cmH2O; minimum EPAP pressure: 4 cmH2O; and tidal volume (Vt) based on 8-10 ml/kg of predicted body weight, being able to be modified according to tolerance.The treatment period will be three months. | Procedure or surgery | Life style modificacion and automatic NIV(AVAPS-AE) |
| CPAP treatment groupIn-laboratory polysomnographic CPAP titration will be performed according to published guidelines for CPAP titration (SEPAR guideline or AASM guideline).In addition to lifestyle modification and oxygen (if require), a home titrated CPAP therapy will be initiated.The treatment period will be three years. | Procedure or surgery | Life style modification and titrated NIV(S/T mode) |
| NIV treatment groupsIn-laboratory polysomnographic NIV titration will be performed according to published guidelines In addition to lifestyle modification and oxygen (if required) home NIV therapy with fixed pressures will be started. The ventilator mode will be a bilevel pressure in S/T mode. The ventilator adjustment will be firstly performed in awake situation and then during sleep by means of a PSG. The treatment period will be three years. | Procedure or surgery | Life style modification and titrated CPAP |
Primary outcome
Medium-term composite hospital resource utilization-mortality
Time frame: 3 months
Primary (medium-term from the first phase or RCT): the medium-term efficacy of automatic NIV treatment versus "lifestyle modifications" treatment in OHS measuring as primary outcome a composite including hospital and ICU admissions, emergency department visits for any cause, and all-cause mortality measured as the number of events
Long-term composite hospital resource utilization-mortality
Time frame: 3 years
Primary (long-term from the second phase or RCT): the long-term efficacy of titrated CPAP therapy versus titrated NIV therapy in OHS measuring as primary outcome a composite including hospital and ICU admissions, emergency department visits for any cause, and all-cause mortality measured as the number of events
38 secondary outcomes
Hospital admissions
Time frame: During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
ICU admissions
Time frame: During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Emergency department visits
Time frame: During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
All-cause mortality
Time frame: During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Duration of hospital admissions
Time frame: During 3 months and during 3 years for the first and second phase or sequential RCTs respectively
Duration of ICU admissions
Time frame: During 3 months and during 3 years for the first and second phase or sequential RCTs respectively
Number of patients who change of the allocated arms
Time frame: During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Causes of change of the allocated treatment
Time frame: During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Clinical symptoms: lower extremity edema
Time frame: During 3 months and during 3 years for first and second phases or sequential RCTs respectively
Clinical symptoms: unrefreshing sleep
Time frame: During 3 months and during 3 years for first and second phases or sequential RCTs respectively
Clinical symptoms: morning fatigue
Time frame: During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Clinical symptoms: nocturia
Time frame: During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Clinical symptoms: headache
Time frame: During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Clinical symptoms: tiredness
Time frame: During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Clinical symptoms: morning confusion
Time frame: During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Clinical symptoms: dysnea
Time frame: During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Clinical symptoms: sleepiness
Time frame: During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Health related quality of life (HRQL): Functional Outcomes of Sleep Questionnaire-- FOSQ--
Time frame: During 3 months and during 3 years for first and second phases or sequential RCTs respectively
Health related quality of life (HRQL): European health-related quality of life questionnaire (EuroQol) EQ-5D-5L
Time frame: During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Health related quality of life (HRQL): Subjective state of illness on a visual analogical scale: Visual Analogical Well-being Scale -VAWS (Masa JF et al. Sleep Breath. 2011;15:549-59) (EuroQol) EQ-5D-5L
Time frame: During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Arterial blood gases (ABG): PaO2
Time frame: During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Arterial blood gases (ABG): PaCO2
Time frame: During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Arterial blood gases (ABG): Bicarbonate
Time frame: During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Arterial blood gases (ABG): pH
Time frame: During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Weight
Time frame: During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Standardized blood pressure measures
Time frame: During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Incidence of cardiovascular events: systemic hypertension
Time frame: During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Incidence of cardiovascular events: arrhythmia
Time frame: During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Incidence of cardiovascular events: nonfatal myocardial infarction
Time frame: During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Incidence of cardiovascular events: hospitalization for unstable angina
Time frame: During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Incidence of cardiovascular events: coronary percutaneous interventions
Time frame: After 3 months and after 3 years for first and second phases or sequential RCTs respectively
Incidence of cardiovascular events: nonfatal stroke or transient ischemic attack
Time frame: During 3 months and during 3 years for first and second phases or sequential RCTs respectively
Incidence of cardiovascular events: heart failure episode
Time frame: During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Incidence of cardiovascular events: cardiovascular death
Time frame: During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Incidence of adverse event
Time frame: During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Cost-effectiveness analysis based on the primary outcome and quality adjusted life year (QALY)
Time frame: During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Number of oro-tracheal intubation
Time frame: During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Duration of tracheal intubation
Time frame: During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Background: PubMed 16963680Storre JH, Seuthe B, Fiechter R, Milioglou S, Dreher M, Sorichter S, Windisch W. Average volume-assured pressure support in obesity hypoventilation: A randomized crossover trial. Chest. 2006 Sep;130(3):815-21. doi: 10.1378/chest.130.3.815.
- Results publication: PubMed 11029353Masa JF, Rubio M, Findley LJ. Habitually sleepy drivers have a high frequency of automobile crashes associated with respiratory disorders during sleep. Am J Respir Crit Care Med. 2000 Oct;162(4 Pt 1):1407-12. doi: 10.1164/ajrccm.162.4.9907019.
- Results publication: PubMed 10080847Teran-Santos J, Jimenez-Gomez A, Cordero-Guevara J. The association between sleep apnea and the risk of traffic accidents. Cooperative Group Burgos-Santander. N Engl J Med. 1999 Mar 18;340(11):847-51. doi: 10.1056/NEJM199903183401104.
- Results publication: PubMed 15781100Marin JM, Carrizo SJ, Vicente E, Agusti AG. Long-term cardiovascular outcomes in men with obstructive sleep apnoea-hypopnoea with or without treatment with continuous positive airway pressure: an observational study. Lancet. 2005 Mar 19-25;365(9464):1046-53. doi: 10.1016/S0140-6736(05)71141-7.
- Results publication: PubMed 11502631Kessler R, Chaouat A, Schinkewitch P, Faller M, Casel S, Krieger J, Weitzenblum E. The obesity-hypoventilation syndrome revisited: a prospective study of 34 consecutive cases. Chest. 2001 Aug;120(2):369-76. doi: 10.1378/chest.120.2.369.
- Results publication: PubMed 25915102Masa JF, Corral J, Alonso ML, Ordax E, Troncoso MF, Gonzalez M, Lopez-Martinez S, Marin JM, Marti S, Diaz-Cambriles T, Chiner E, Aizpuru F, Egea C; Spanish Sleep Network. Efficacy of Different Treatment Alternatives for Obesity Hypoventilation Syndrome. Pickwick Study. Am J Respir Crit Care Med. 2015 Jul 1;192(1):86-95. doi: 10.1164/rccm.201410-1900OC.
- Results publication: PubMed 25671545Castro-Anon O, Perez de Llano LA, De la Fuente Sanchez S, Golpe R, Mendez Marote L, Castro-Castro J, Gonzalez Quintela A. Obesity-hypoventilation syndrome: increased risk of death over sleep apnea syndrome. PLoS One. 2015 Feb 11;10(2):e0117808. doi: 10.1371/journal.pone.0117808. eCollection 2015.
- Results publication: PubMed 24028180Basoglu OK, Tasbakan MS. Comparison of clinical characteristics in patients with obesity hypoventilation syndrome and obese obstructive sleep apnea syndrome: a case-control study. Clin Respir J. 2014 Apr;8(2):167-74. doi: 10.1111/crj.12054. Epub 2013 Nov 28.
- Results publication: PubMed 20348200Priou P, Hamel JF, Person C, Meslier N, Racineux JL, Urban T, Gagnadoux F. Long-term outcome of noninvasive positive pressure ventilation for obesity hypoventilation syndrome. Chest. 2010 Jul;138(1):84-90. doi: 10.1378/chest.09-2472. Epub 2010 Mar 26.
- Results publication: PubMed 11502632Berg G, Delaive K, Manfreda J, Walld R, Kryger MH. The use of health-care resources in obesity-hypoventilation syndrome. Chest. 2001 Aug;120(2):377-83. doi: 10.1378/chest.120.2.377.
- Results publication: PubMed 29146865Corral J, Mogollon MV, Sanchez-Quiroga MA, Gomez de Terreros J, Romero A, Caballero C, Teran-Santos J, Alonso-Alvarez ML, Gomez-Garcia T, Gonzalez M, Lopez-Martinez S, de Lucas P, Marin JM, Romero O, Diaz-Cambriles T, Chiner E, Egea C, Lang RM, Mokhlesi B, Masa JF; Spanish Sleep Network. Echocardiographic changes with non-invasive ventilation and CPAP in obesity hypoventilation syndrome. Thorax. 2018 Apr;73(4):361-368. doi: 10.1136/thoraxjnl-2017-210642. Epub 2017 Nov 16.
- Results publication: PubMed 26923627Masa JF, Corral J, Romero A, Caballero C, Teran-Santos J, Alonso-Alvarez ML, Gomez-Garcia T, Gonzalez M, Lopez-Martin S, De Lucas P, Marin JM, Marti S, Diaz-Cambriles T, Chiner E, Merchan M, Egea C, Obeso A, Mokhlesi B; Spanish Sleep Network( *). Protective Cardiovascular Effect of Sleep Apnea Severity in Obesity Hypoventilation Syndrome. Chest. 2016 Jul;150(1):68-79. doi: 10.1016/j.chest.2016.02.647. Epub 2016 Feb 27.
- Individual participant dataSharing planned: Yes. Additional related documents such as study protocol, statistical analysis plan, and informed consent form will be available upon request from the Project principal investigator (Dr. Juan Fernando Masa). Deidentified patients' data can be requested by researchers for use in independent scientific research and will be provided following review and approval of the research proposal (including statistical analysis plan) and completion of a data sharing agreement with the Project Publications Committee. Investigator Data requests can be made anytime from 1 to 2 years after the publication of this trial. Requests should be sent to the corresponding author (Dr. Juan Fernando Masa- fmasa@separ.es).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan F Masa, MD, Phd principal investigator
Servicio Extremeño de Salud
Babak Mokhlesi, MD, Prof principal investigator
Rush University Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Automatic NIV, CPAP treatment group and NIV treatment groups in people with Acute on Chronic Hypercapnic Respiratory Failure and Obesity Hypoventilation Syndrome (OHS), run by Juan F. Masa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medium-term composite hospital resource utilization-mortality (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04317326, which also lists 35 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2023.