Acute Hypoxic Respiratory FailureNCT06490523
Analysis of Advanced Physiological Ventilatory Parameters During Spontaneous Breathing Effort in Patients with Acute Hypoxemic Respiratory Failure
An observational study of Acute Hypoxic Respiratory Failure, run by Hospital del Mar Research Institute (IMIM) at 1 site in Spain.
Trial summary
The aim of this prospective physiological cohort study conducted in a medical intensive care unit (ICU) at Hospital del Mar in Barcelona, Spain, was to analyze the proportion of time spent within the "safe" range of respiratory effort (including esophageal pressure swing (ΔPes), respiratory muscular pressure (Pmus)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Hypoxic Respiratory Failure
- How many people
- 31 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2020to 30 Nov 2022
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients aged 18 years or older who were admitted to the ICU and required invasive mechanical ventilation (IMV) for acute hypoxemic respiratory failure (AHRF) were eligible for the study. Patients were excluded if they had chest drains, a contraindication to esophageal catheterization (e.g., recent upper gastrointestinal surgery, bleeding esophageal varices), or a concomitant acute exacerbation of obstructive airways disease.
Who may be able to join
- Acute hypoxemic respiratory failure patients requiring invasive mechanical ventialtion
Who cannot join
- Presence of chest drains
- Contraindication to esophageal catheterization (e.g., recent upper gastrointestinal surgery, bleeding esophageal varices)
- Concomitant acute exacerbation of obstructive airways disease
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this prospective physiological cohort study conducted in a medical intensive care unit (ICU) at Hospital del Mar in Barcelona, Spain, was to analyze the proportion of time spent within the "safe" range of respiratory effort (including esophageal pressure swing (ΔPes), respiratory muscular pressure (Pmus), and transdiaphragmatic pressure swing (ΔPdi)) in patients with acute hypoxemic respiratory failure (AHRF) undergoing invasive mechanical ventilation (IMV), during the active breathing phase in relation to ICU survival.
The investigators hypothesized that AHRF patients on IMV with better outcome (i.e., ICU survivors) spend more time within the "safe" range of respiratory effort during the active breathing phase compared to non-survivors.
AHRF patients on IMV were continuously monitored with esophageal and gastric manometry from the detection of the onset of respiratory effort for up to 7 days, or until extubation, or until death, whichever occurred first.
Read the detailed description
To characterize in detail the evolution of respiratory effort over time, the investigators conducted a prospective observational cohort study with continuous recordings of airway pressure, flow, esophageal and gastric pressures for up to 7 days after the onset of respiratory effort in AHRF patients on IMV.
Patients were classified into two groups: ICU survivors and ICU non-survivors. The primary objective of the study was to analyze the proportion of time spent within a specified "safe" range for Pmus, ΔPes, and ΔPdi (respiratory effort physiological variables), during spontaneous breathing, comparing both groups during the first 7 days after the initiation of respiratory effort. The secondary objective was to analyze the median values of ΔPes, Pmus, and ΔPdi during the monitorization period (active breathing phase) between the two groups.
- Conditions
- Acute Hypoxic Respiratory Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ICU survivors | Acute hypoxemic respiratory failure patients on invasive mechanical ventilation who survive to ICU discharge | |
| ICU non-survivors | Acute hypoxemic respiratory failure patients on invasive mechanical ventilation who do not survive to ICU discharge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of time spent in different ranges of ΔPes (low, safe, and high) during the active breathing phase between the two groups
The defined "safe" range for ΔPes was -5 to -10 cm H2O. Effort outside the defined "safe" range was categorized as "low" if it fell below the lower limit, or "high" if it exceeded the upper limit of the safe range for the variable.
Measured: From the start the start of respiratory effort up to 7 days (or until extubation or death, if earlier)
Proportion of time spent in different ranges of Pmus (low, safe, and high) during the active breathing phase between the two groups
The defined "safe" range for Pmus was 5 to 15 cm H2O. Effort outside the defined "safe" range was categorized as "low" if it fell below the lower limit, or "high" if it exceeded the upper limit of the safe range for the variable.
Measured: From the start the start of respiratory effort up to 7 days (or until extubation or death, if earlier)
Proportion of time spent in different ranges of ΔPdi (low, safe, and high) during the active breathing phase between the two groups
The defined "safe" range for ΔPdi was 3 to 12 cm H2O. Effort outside the defined "safe" range was categorized as "low" if it fell below the lower limit, or "high" if it exceeded the upper limit of the safe range for the variable.
Measured: From the start the start of respiratory effort up to 7 days (or until extubation or death, if earlier)
Median value of ΔPes during the active breathing phase between the two groups
To analyze the median value of ΔPes during the active breathing phase between the two groups in cm H20.
Measured: From the start the start of respiratory effort up to 7 days (or until extubation or death, if earlier)
Median value of Pmus during the active breathing phase between the two groups
To analyze the median value of Pmus during the active breathing phase between the two groups in cm H20.
Measured: From the start the start of respiratory effort up to 7 days (or until extubation or death, if earlier)
Median value of ΔPdi during the active breathing phase between the two groups
To analyze the median value of ΔPdi during the active breathing phase between the two groups in cm H20.
Measured: From the start the start of respiratory effort up to 7 days (or until extubation or death, if earlier)
Secondary outcomes (6)
The need for the use of venovenous (VV) extracorporeal membrane oxygenation (ECMO)
Initiation of VV ECMO during the mechanical ventilation period (yes or no)
Measured: From date of initiation of invasive mechanical ventilation until extubation or date of death from any cause, whichever came first, assessed up to 24 months
The need for the use of extracorporeal CO2 removal (ECCO2R)
Initiation of ECCO2R during the mechanical ventilation period (yes or no)
Measured: From date of initiation of invasive mechanical ventilation until extubation or date of death from any cause, whichever came first, assessed up to 24 months
The need for a Tracheostomy
The need to perfom a tracheostomy duduring the mechanical ventilation period (yes or no)
Measured: From date of initiation of invasive mechanical ventilation until extubation or date of death from any cause, whichever came first, assessed up to 24 months
Duration of invasive mechanical ventilation (IMV)
Duration of IMV measured in days
Measured: From date of initiation of invasive mechanical ventilation until extubation or date of death from any cause, whichever came first, assessed up to 24 months
Intensive care Unit (ICU) Length of stay
Duration of the ICU admission measured in days
Measured: From date of ICU admission until date of ICU discharge or date of death from any cause, whichever came first, assessed up to 24 months
Hospital Length of stay
Duration of the Hospital admission measured in days
Measured: From date of Hospital admission until date of Hospital discharge or date of death from any cause, whichever came first, assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start1 Dec 2020
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Acute Hypoxic 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital del Mar Research Institute (IMIM)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Castellvi, Hospital del Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06490523
- Sponsor's protocol ID
- 2021/9742
- Status last verified
- Jun 2024
- First submitted
- 25 Jun 2024
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291.
PubMed 26903337Telias I, Brochard LJ, Gattarello S, Wunsch H, Junhasavasdikul D, Bosma KJ, Camporota L, Brodie D, Marini JJ, Slutsky AS, Gattinoni L. The physiological underpinnings of life-saving respiratory support. Intensive Care Med. 2022 Oct;48(10):1274-1286. doi: 10.1007/s00134-022-06749-3. Epub 2022 Jun 12.
PubMed 35690953Sklar MC, Madotto F, Jonkman A, Rauseo M, Soliman I, Damiani LF, Telias I, Dubo S, Chen L, Rittayamai N, Chen GQ, Goligher EC, Dres M, Coudroy R, Pham T, Artigas RM, Friedrich JO, Sinderby C, Heunks L, Brochard L. Duration of diaphragmatic inactivity after endotracheal intubation of critically ill patients. Crit Care. 2021 Jan 11;25(1):26. doi: 10.1186/s13054-020-03435-y.
PubMed 33430930Yoshida T, Fujino Y, Amato MB, Kavanagh BP. Fifty Years of Research in ARDS. Spontaneous Breathing during Mechanical Ventilation. Risks, Mechanisms, and Management. Am J Respir Crit Care Med. 2017 Apr 15;195(8):985-992. doi: 10.1164/rccm.201604-0748CP.
PubMed 27786562Yoshida T, Uchiyama A, Matsuura N, Mashimo T, Fujino Y. Spontaneous breathing during lung-protective ventilation in an experimental acute lung injury model: high transpulmonary pressure associated with strong spontaneous breathing effort may worsen lung injury. Crit Care Med. 2012 May;40(5):1578-85. doi: 10.1097/CCM.0b013e3182451c40.
PubMed 22430241Goligher EC. Myotrauma in mechanically ventilated patients. Intensive Care Med. 2019 Jun;45(6):881-884. doi: 10.1007/s00134-019-05557-6. Epub 2019 Feb 11. No abstract available.
PubMed 30741329Goligher EC, Brochard LJ, Reid WD, Fan E, Saarela O, Slutsky AS, Kavanagh BP, Rubenfeld GD, Ferguson ND. Diaphragmatic myotrauma: a mediator of prolonged ventilation and poor patient outcomes in acute respiratory failure. Lancet Respir Med. 2019 Jan;7(1):90-98. doi: 10.1016/S2213-2600(18)30366-7. Epub 2018 Nov 16.
PubMed 30455078Goligher EC, Dres M, Fan E, Rubenfeld GD, Scales DC, Herridge MS, Vorona S, Sklar MC, Rittayamai N, Lanys A, Murray A, Brace D, Urrea C, Reid WD, Tomlinson G, Slutsky AS, Kavanagh BP, Brochard LJ, Ferguson ND. Mechanical Ventilation-induced Diaphragm Atrophy Strongly Impacts Clinical Outcomes. Am J Respir Crit Care Med. 2018 Jan 15;197(2):204-213. doi: 10.1164/rccm.201703-0536OC.
PubMed 28930478Kondili E, Alexopoulou C, Xirouchaki N, Vaporidi K, Georgopoulos D. Estimation of inspiratory muscle pressure in critically ill patients. Intensive Care Med. 2010 Apr;36(4):648-55. doi: 10.1007/s00134-010-1753-4. Epub 2010 Jan 28.
PubMed 20107765Mauri T, Yoshida T, Bellani G, Goligher EC, Carteaux G, Rittayamai N, Mojoli F, Chiumello D, Piquilloud L, Grasso S, Jubran A, Laghi F, Magder S, Pesenti A, Loring S, Gattinoni L, Talmor D, Blanch L, Amato M, Chen L, Brochard L, Mancebo J; PLeUral pressure working Group (PLUG-Acute Respiratory Failure section of the European Society of Intensive Care Medicine). Esophageal and transpulmonary pressure in the clinical setting: meaning, usefulness and perspectives. Intensive Care Med. 2016 Sep;42(9):1360-73. doi: 10.1007/s00134-016-4400-x. Epub 2016 Jun 22.
PubMed 27334266Akoumianaki E, Maggiore SM, Valenza F, Bellani G, Jubran A, Loring SH, Pelosi P, Talmor D, Grasso S, Chiumello D, Guerin C, Patroniti N, Ranieri VM, Gattinoni L, Nava S, Terragni PP, Pesenti A, Tobin M, Mancebo J, Brochard L; PLUG Working Group (Acute Respiratory Failure Section of the European Society of Intensive Care Medicine). The application of esophageal pressure measurement in patients with respiratory failure. Am J Respir Crit Care Med. 2014 Mar 1;189(5):520-31. doi: 10.1164/rccm.201312-2193CI.
PubMed 24467647Jonkman AH, Telias I, Spinelli E, Akoumianaki E, Piquilloud L. The oesophageal balloon for respiratory monitoring in ventilated patients: updated clinical review and practical aspects. Eur Respir Rev. 2023 May 17;32(168):220186. doi: 10.1183/16000617.0186-2022. Print 2023 Jun 30.
PubMed 37197768Chiumello D, Consonni D, Coppola S, Froio S, Crimella F, Colombo A. The occlusion tests and end-expiratory esophageal pressure: measurements and comparison in controlled and assisted ventilation. Ann Intensive Care. 2016 Dec;6(1):13. doi: 10.1186/s13613-016-0112-1. Epub 2016 Feb 12.
PubMed 26868503Goligher EC, Dres M, Patel BK, Sahetya SK, Beitler JR, Telias I, Yoshida T, Vaporidi K, Grieco DL, Schepens T, Grasselli G, Spadaro S, Dianti J, Amato M, Bellani G, Demoule A, Fan E, Ferguson ND, Georgopoulos D, Guerin C, Khemani RG, Laghi F, Mercat A, Mojoli F, Ottenheijm CAC, Jaber S, Heunks L, Mancebo J, Mauri T, Pesenti A, Brochard L. Lung- and Diaphragm-Protective Ventilation. Am J Respir Crit Care Med. 2020 Oct 1;202(7):950-961. doi: 10.1164/rccm.202003-0655CP.
PubMed 32516052Carteaux G, Mancebo J, Mercat A, Dellamonica J, Richard JC, Aguirre-Bermeo H, Kouatchet A, Beduneau G, Thille AW, Brochard L. Bedside adjustment of proportional assist ventilation to target a predefined range of respiratory effort. Crit Care Med. 2013 Sep;41(9):2125-32. doi: 10.1097/CCM.0b013e31828a42e5.
PubMed 23787397
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Advanced Physiological Ventilatory Parameters During Spontaneous Breathing Effort in Patients with Acute Hypoxemic Respiratory Failure
- ClinicalTrials.gov ID
- NCT06490523
- Acronym / sponsor ID
- 2021/9742
- Conditions
- Acute Hypoxic Respiratory Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Hospital del Mar Research Institute (IMIM)University, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 8 Jul 2024 (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.
The aim of this prospective physiological cohort study conducted in a medical intensive care unit (ICU) at Hospital del Mar in Barcelona, Spain, was to analyze the proportion of time spent within the "safe" range of respiratory effort (including esophageal pressure swing (ΔPes), respiratory muscular pressure (Pmus), and transdiaphragmatic pressure swing (ΔPdi)) in patients with acute hypoxemic respiratory failure (AHRF) undergoing invasive mechanical ventilation (IMV), during the active breathing phase in relation to ICU survival.
The investigators hypothesized that AHRF patients on IMV with better outcome (i.e., ICU survivors) spend more time within the "safe" range of respiratory effort during the active breathing phase compared to non-survivors.
AHRF patients on IMV were continuously monitored with esophageal and gastric manometry from the detection of the onset of respiratory effort for up to 7 days, or until extubation, or until death, whichever occurred first.
Detailed description
To characterize in detail the evolution of respiratory effort over time, the investigators conducted a prospective observational cohort study with continuous recordings of airway pressure, flow, esophageal and gastric pressures for up to 7 days after the onset of respiratory effort in AHRF patients on IMV.
Patients were classified into two groups: ICU survivors and ICU non-survivors. The primary objective of the study was to analyze the proportion of time spent within a specified "safe" range for Pmus, ΔPes, and ΔPdi (respiratory effort physiological variables), during spontaneous breathing, comparing both groups during the first 7 days after the initiation of respiratory effort. The secondary objective was to analyze the median values of ΔPes, Pmus, and ΔPdi during the monitorization period (active breathing phase) between the two groups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICU survivors | – | –Acute hypoxemic respiratory failure patients on invasive mechanical ventilation who survive to ICU discharge |
| ICU non-survivors | – | –Acute hypoxemic respiratory failure patients on invasive mechanical ventilation who do not survive to ICU discharge |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients aged 18 years or older who were admitted to the ICU and required invasive mechanical ventilation (IMV) for acute hypoxemic respiratory failure (AHRF) were eligible for the study. Patients were excluded if they had chest drains, a contraindication to esophageal catheterization (e.g., recent upper gastrointestinal surgery, bleeding esophageal varices), or a concomitant acute exacerbation of obstructive airways disease.
Key inclusion criteria (1 listed)
- Acute hypoxemic respiratory failure patients requiring invasive mechanical ventialtion
Key exclusion criteria (3 listed)
- Presence of chest drains
- Contraindication to esophageal catheterization (e.g., recent upper gastrointestinal surgery, bleeding esophageal varices)
- Concomitant acute exacerbation of obstructive airways disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of time spent in different ranges of ΔPes (low, safe, and high) during the active breathing phase between the two groups
Time frame: From the start the start of respiratory effort up to 7 days (or until extubation or death, if earlier)
The defined "safe" range for ΔPes was -5 to -10 cm H2O. Effort outside the defined "safe" range was categorized as "low" if it fell below the lower limit, or "high" if it exceeded the upper limit of the safe range for the variable.
Proportion of time spent in different ranges of Pmus (low, safe, and high) during the active breathing phase between the two groups
Time frame: From the start the start of respiratory effort up to 7 days (or until extubation or death, if earlier)
The defined "safe" range for Pmus was 5 to 15 cm H2O. Effort outside the defined "safe" range was categorized as "low" if it fell below the lower limit, or "high" if it exceeded the upper limit of the safe range for the variable.
Proportion of time spent in different ranges of ΔPdi (low, safe, and high) during the active breathing phase between the two groups
Time frame: From the start the start of respiratory effort up to 7 days (or until extubation or death, if earlier)
The defined "safe" range for ΔPdi was 3 to 12 cm H2O. Effort outside the defined "safe" range was categorized as "low" if it fell below the lower limit, or "high" if it exceeded the upper limit of the safe range for the variable.
Median value of ΔPes during the active breathing phase between the two groups
Time frame: From the start the start of respiratory effort up to 7 days (or until extubation or death, if earlier)
To analyze the median value of ΔPes during the active breathing phase between the two groups in cm H20.
Median value of Pmus during the active breathing phase between the two groups
Time frame: From the start the start of respiratory effort up to 7 days (or until extubation or death, if earlier)
To analyze the median value of Pmus during the active breathing phase between the two groups in cm H20.
Median value of ΔPdi during the active breathing phase between the two groups
Time frame: From the start the start of respiratory effort up to 7 days (or until extubation or death, if earlier)
To analyze the median value of ΔPdi during the active breathing phase between the two groups in cm H20.
6 secondary outcomes
The need for the use of venovenous (VV) extracorporeal membrane oxygenation (ECMO)
Time frame: From date of initiation of invasive mechanical ventilation until extubation or date of death from any cause, whichever came first, assessed up to 24 months
The need for the use of extracorporeal CO2 removal (ECCO2R)
Time frame: From date of initiation of invasive mechanical ventilation until extubation or date of death from any cause, whichever came first, assessed up to 24 months
The need for a Tracheostomy
Time frame: From date of initiation of invasive mechanical ventilation until extubation or date of death from any cause, whichever came first, assessed up to 24 months
Duration of invasive mechanical ventilation (IMV)
Time frame: From date of initiation of invasive mechanical ventilation until extubation or date of death from any cause, whichever came first, assessed up to 24 months
Intensive care Unit (ICU) Length of stay
Time frame: From date of ICU admission until date of ICU discharge or date of death from any cause, whichever came first, assessed up to 24 months
Hospital Length of stay
Time frame: From date of Hospital admission until date of Hospital discharge or date of death from any cause, whichever came first, assessed up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Background: PubMed 26903337Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291.
- Background: PubMed 35690953Telias I, Brochard LJ, Gattarello S, Wunsch H, Junhasavasdikul D, Bosma KJ, Camporota L, Brodie D, Marini JJ, Slutsky AS, Gattinoni L. The physiological underpinnings of life-saving respiratory support. Intensive Care Med. 2022 Oct;48(10):1274-1286. doi: 10.1007/s00134-022-06749-3. Epub 2022 Jun 12.
- Background: PubMed 33430930Sklar MC, Madotto F, Jonkman A, Rauseo M, Soliman I, Damiani LF, Telias I, Dubo S, Chen L, Rittayamai N, Chen GQ, Goligher EC, Dres M, Coudroy R, Pham T, Artigas RM, Friedrich JO, Sinderby C, Heunks L, Brochard L. Duration of diaphragmatic inactivity after endotracheal intubation of critically ill patients. Crit Care. 2021 Jan 11;25(1):26. doi: 10.1186/s13054-020-03435-y.
- Background: PubMed 27786562Yoshida T, Fujino Y, Amato MB, Kavanagh BP. Fifty Years of Research in ARDS. Spontaneous Breathing during Mechanical Ventilation. Risks, Mechanisms, and Management. Am J Respir Crit Care Med. 2017 Apr 15;195(8):985-992. doi: 10.1164/rccm.201604-0748CP.
- Background: PubMed 22430241Yoshida T, Uchiyama A, Matsuura N, Mashimo T, Fujino Y. Spontaneous breathing during lung-protective ventilation in an experimental acute lung injury model: high transpulmonary pressure associated with strong spontaneous breathing effort may worsen lung injury. Crit Care Med. 2012 May;40(5):1578-85. doi: 10.1097/CCM.0b013e3182451c40.
- Background: PubMed 30741329Goligher EC. Myotrauma in mechanically ventilated patients. Intensive Care Med. 2019 Jun;45(6):881-884. doi: 10.1007/s00134-019-05557-6. Epub 2019 Feb 11. No abstract available.
- Background: PubMed 30455078Goligher EC, Brochard LJ, Reid WD, Fan E, Saarela O, Slutsky AS, Kavanagh BP, Rubenfeld GD, Ferguson ND. Diaphragmatic myotrauma: a mediator of prolonged ventilation and poor patient outcomes in acute respiratory failure. Lancet Respir Med. 2019 Jan;7(1):90-98. doi: 10.1016/S2213-2600(18)30366-7. Epub 2018 Nov 16.
- Background: PubMed 28930478Goligher EC, Dres M, Fan E, Rubenfeld GD, Scales DC, Herridge MS, Vorona S, Sklar MC, Rittayamai N, Lanys A, Murray A, Brace D, Urrea C, Reid WD, Tomlinson G, Slutsky AS, Kavanagh BP, Brochard LJ, Ferguson ND. Mechanical Ventilation-induced Diaphragm Atrophy Strongly Impacts Clinical Outcomes. Am J Respir Crit Care Med. 2018 Jan 15;197(2):204-213. doi: 10.1164/rccm.201703-0536OC.
- Background: PubMed 20107765Kondili E, Alexopoulou C, Xirouchaki N, Vaporidi K, Georgopoulos D. Estimation of inspiratory muscle pressure in critically ill patients. Intensive Care Med. 2010 Apr;36(4):648-55. doi: 10.1007/s00134-010-1753-4. Epub 2010 Jan 28.
- Background: PubMed 27334266Mauri T, Yoshida T, Bellani G, Goligher EC, Carteaux G, Rittayamai N, Mojoli F, Chiumello D, Piquilloud L, Grasso S, Jubran A, Laghi F, Magder S, Pesenti A, Loring S, Gattinoni L, Talmor D, Blanch L, Amato M, Chen L, Brochard L, Mancebo J; PLeUral pressure working Group (PLUG-Acute Respiratory Failure section of the European Society of Intensive Care Medicine). Esophageal and transpulmonary pressure in the clinical setting: meaning, usefulness and perspectives. Intensive Care Med. 2016 Sep;42(9):1360-73. doi: 10.1007/s00134-016-4400-x. Epub 2016 Jun 22.
- Background: PubMed 24467647Akoumianaki E, Maggiore SM, Valenza F, Bellani G, Jubran A, Loring SH, Pelosi P, Talmor D, Grasso S, Chiumello D, Guerin C, Patroniti N, Ranieri VM, Gattinoni L, Nava S, Terragni PP, Pesenti A, Tobin M, Mancebo J, Brochard L; PLUG Working Group (Acute Respiratory Failure Section of the European Society of Intensive Care Medicine). The application of esophageal pressure measurement in patients with respiratory failure. Am J Respir Crit Care Med. 2014 Mar 1;189(5):520-31. doi: 10.1164/rccm.201312-2193CI.
- Background: PubMed 37197768Jonkman AH, Telias I, Spinelli E, Akoumianaki E, Piquilloud L. The oesophageal balloon for respiratory monitoring in ventilated patients: updated clinical review and practical aspects. Eur Respir Rev. 2023 May 17;32(168):220186. doi: 10.1183/16000617.0186-2022. Print 2023 Jun 30.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Hypoxic Respiratory Failure, run by Hospital del Mar Research Institute (IMIM) at 1 site in Spain.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of time spent in different ranges of ΔPes (low, safe, and high) during the active breathing phase between the two groups (time frame: From the start the start of respiratory effort up to 7 days (or until extubation or death, if earlier)). The study lists 6 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 NCT06490523, which also lists 17 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 20 Nov 2024.