Respiratory EffortEFFORT-1NCT06433076
The Association Between Respiratory Effort Parameters During the First 48 Hours With Clinical Outcomes in Mechanically Ventilated Patients: A Prospective Observational Study.
An observational study of Respiratory Effort and Respiratory Distress Syndrome, run by Ramathibodi Hospital at 1 site in Thailand.
Trial summary
Over-assisted mechanical ventilation (MV) is linked to respiratory muscle disuse atrophy, while under-assisted MV can lead to patient self-inflicted lung injury (P-SILI) or respiratory muscle injuries. Both scenarios result in poor outcomes. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Respiratory Effort, Respiratory Distress Syndrome, Lung Mechanics
- How many people
- 163 participants
- Where
- 1 siteThailand
- Study dates
- 8 Jun 2022to 30 Apr 2024
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A single-center analytical observational prospective study was conducted between June 2022 and April 2024. We enrolled acute respiratory failure patients who required mechanical ventilation from the intensive care units (ICUs) at Ramathibodi Hospital, Mahidol University.
Who may be able to join
- Participants must be aged between 18-75 years.
- Admitted to the critical care and semi-critical care units (ICUs) of the Department of -Internal Medicine, Ramathibodi Hospital (ICUs 9IC, 8IK, and 7NW).
- Patients with acute respiratory failure admitted to the hospital with the following conditions within the first 48 hours:
- PaO2/FiO2 greater than 150 or
- PaO2 less than 60 mm Hg or
- SaO2 less than 90 mm Hg or
Show all 10Show fewer
- Work of breathing more than 25 breaths per minute or requiring respiratory muscle assistance
- Permission obtained from the attending physician.
- Research participants or their direct relatives must sign informed consent.
- The research can commence and data can be recorded within 48 hours after the patient has received treatment with the mechanical ventilator.
Who cannot join
- Admitted to the hospital or had a history of hospital admission within a month before recruitment.
- History of cardiovascular or cerebrovascular events within the last 12 months.
- Pregnant.
- Terminal-stage cancer patient, terminal illness-stage of disease who desire palliative care.
- Active neurological or muscular disorders affecting stability.
- Brain coma, brain death, or status epilepticus.
Show all 10Show fewer
- Severe mental health conditions, including active depression with psychotic features, bipolar disorder, or schizophrenia.
- Uncontrolled thyroid conditions within a month before recruitment.
- Uncorrectable patients with severe hypoxemia (P/F ratio less than 150).
- Patients receiving neuromuscular blocking agents.
Trial locations and contacts
1 site in 1 country.
About this study
Over-assisted mechanical ventilation (MV) is linked to respiratory muscle disuse atrophy, while under-assisted MV can lead to patient self-inflicted lung injury (P-SILI) or respiratory muscle injuries. Both scenarios result in poor outcomes. This hypothesis aims to demonstrate the association between the degree of respiratory effort which was measured by P0.1, predicted Pmus, and predicted Δtranspulmonary pressure (ΔPL) with ventilator-free days (VFD) and 28-day mortality.
Read the detailed description
Recently, the lung and diaphragm protective strategy is an important consideration when providing mechanical ventilation to critically ill patients. Although mechanical ventilation can be life-saving, improper management can cause harm. The harmful mechanical ventilator setting can result from over-assisted or under-assisted ventilation. Over-assisted ventilation can be caused by too much ventilatory support or calming down patients with high dosages of sedative drugs or muscle relaxants, which negatively affect the operation of the diaphragm leading to diaphragm muscle atrophy and weakness. This can make it more difficult to weaning and lead to prolonged use of mechanical ventilation. It appears that previous study found a correlation between percentage change in diaphragm thickness fraction, as measured by ultrasound, during the first week of mechanical ventilation and prolonged duration of mechanical ventilation, extended length of stay in the ICU, and complications. Additionally, in the study conclusions, a diaphragm thickness fraction of 15-30% during the first three days of mechanical ventilation was associated with the shortest duration of mechanical ventilation and this may potentially help guide the management of respiratory support.
On the other hand, the effect of under-assist breathing or allowing excessive respiratory effort could be harmful. Some reported in chronic obstructive pulmonary disease (COPD) exacerbation patients found that the increased negative intra-thoracic pressure potentially causes injury to the diaphragm sarcomeres, which are the muscle fibers responsible for generating force during breathing and it was proportional to the degree of obstruction. And compared light microscopy of the diaphragmatic muscles necropsy in patients who died of COPD with normal subjects. They found muscular necrosis and accumulation of fibrosis and collagen deposits. The cytoplasm was scattered, disrupted, and lipofuscin accumulation with hyper-eosinophilia was observed.
In addition, an excessive high respiratory effort can cause lung injury by patient-self known as patient self-inflicted lung injury (P-SILI), a theory first mentioned that the increased magnitude of negative intrathoracic pressure during inhalation may cause the fluid shift from the pulmonary capillaries to the alveoli causing pulmonary edema. This is relevant to the observational studies that the occurrence of negative intrathoracic pressure during large inhalations in obstruction airway patients, such as tracheal stenosis, also results in pulmonary edema. In latterly confirmed this hypothesis. Subsequent studies have supported this phenomenon and overall could be explained through the increase of transpulmonary pressure, pendelluft phenomenon and patient-ventilator asynchrony (PVA).
However, no current studies determine the relationship between respiratory effort measurement during mechanical ventilation and clinical outcomes. Therefore, we conduct the study to determine the relationship between respiratory effort parameters and clinical outcomes.
- Keywords
- Respiratory effort, Acute respiratory distress syndrome (ARDS), Dynamic transpulmonary pressure swing (Predicted ΔPL), Patient self-inflicted lung injury (P-SILI), Patient ventilator asynchrony (PVA)
- Medical subject headings
- Respiratory Distress Syndrome, Patient-Ventilator Asynchrony
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 |
|---|---|---|
| Preference respiratory effort | The preference respiratory effort group was defined by either 1.5≤P0.1≤3.5 cmH2O, 5≤ predicted Pmus≤10 cmH2O, or predicted ΔPL≤20 cmH2O. | |
| Insufficiency respiratory effort | The insufficiency respiratory effort group was defined by either P0.1<1.5 cmH2O or predicted Pmus < 5 cmH2O. | |
| Excessive respiratory effort | The excessive respiratory effort group was defined by either P0.1 > 3.5 cmH2O, predicted Pmus > 10 cmH2O, or predicted ΔPL > 20 cmH2O. |
What is being measured
The primary outcome is the main question the study is designed to answer.
28 days ventilator-free days (VFDs)
The number of VFDs was defined as the number of days from the last day of mechanical ventilation to day 28. If a patient died during the first 28 days, their number of VFDs is equal to zero.
Measured: After intubated patients were recruited until successful extubation or dead/failed extubation with in 28 days.
Secondary outcomes (1)
28 days all-cause mortality
Short-term mortality was defined as death occurring within 28 days from the start of enrollment, documented as either alive or deceased 28 days after intubation.
Measured: After intubated patients were recruited until alive or dead with in 28 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study start8 Jun 2022
- Primary completion31 Mar 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Respiratory EffortStudies 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
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ramathibodi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Phruet Soipetkasem, Ramathibodi Hospital
- Investigators
- Mr. Phruet Soipetkasem, Critical care doctor, Principal investigator, Doctor of Critical care medicine Ramathibodi hospitalPongdhep Theerawit, Assoc. Prof., Study chair, Head of Critical care medicine Ramathibodi hospitalYuda Sutherasan, Assoc. Prof., Study director, Clinical professor of Pulmonary and Critical care medicine Ramathibodi hospitalMr. Detajin Junhasavasdikul, Asst.Prof., Study director, Clinical professor of Pulmonary and Critical care medicine Ramathibodi hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06433076
- Sponsor's protocol ID
- COA. MURA2022/317
- Acronym
- EFFORT-1
- Status last verified
- May 2024
- First submitted
- 19 May 2024
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Beduneau G, Pham T, Schortgen F, Piquilloud L, Zogheib E, Jonas M, Grelon F, Runge I, Nicolas Terzi, Grange S, Barberet G, Guitard PG, Frat JP, Constan A, Chretien JM, Mancebo J, Mercat A, Richard JM, Brochard L; WIND (Weaning according to a New Definition) Study Group and the REVA (Reseau Europeen de Recherche en Ventilation Artificielle) Network double dagger. Epidemiology of Weaning Outcome according to a New Definition. The WIND Study. Am J Respir Crit Care Med. 2017 Mar 15;195(6):772-783. doi: 10.1164/rccm.201602-0320OC.
PubMed 27626706Goligher 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 28930478Orozco-Levi M, Lloreta J, Minguella J, Serrano S, Broquetas JM, Gea J. Injury of the human diaphragm associated with exertion and chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2001 Nov 1;164(9):1734-9. doi: 10.1164/ajrccm.164.9.2011150.
PubMed 11719318Scott A, Wang X, Road JD, Reid WD. Increased injury and intramuscular collagen of the diaphragm in COPD: autopsy observations. Eur Respir J. 2006 Jan;27(1):51-9. doi: 10.1183/09031936.06.00143004.
PubMed 16387935Loeb L. The Mechanism in the Development of Pulmonary Edema. Proceedings of the Society for Experimental Biology and Medicine. 1928;25(5):321-323. doi:10.3181/00379727-25-3837
Moore RL, Binger CA. THE RESPONSE TO RESPIRATORY RESISTANCE : A COMPARISON OF THE EFFECTS PRODUCED BY PARTIAL OBSTRUCTION IN THE INSPIRATORY AND EXPIRATORY PHASES OF RESPIRATION. J Exp Med. 1927 May 31;45(6):1065-80. doi: 10.1084/jem.45.6.1065.
PubMed 19869306Barach AL, Eckman M. THE EFFECTS OF INHALATION OF HELIUM MIXED WITH OXYGEN ON THE MECHANICS OF RESPIRATION. J Clin Invest. 1936 Jan;15(1):47-61. doi: 10.1172/JCI100758. No abstract available.
PubMed 16694380Dreyfuss D, Soler P, Basset G, Saumon G. High inflation pressure pulmonary edema. Respective effects of high airway pressure, high tidal volume, and positive end-expiratory pressure. Am Rev Respir Dis. 1988 May;137(5):1159-64. doi: 10.1164/ajrccm/137.5.1159.
PubMed 3057957Yoshida T, Uchiyama A, Matsuura N, Mashimo T, Fujino Y. The comparison of spontaneous breathing and muscle paralysis in two different severities of experimental lung injury. Crit Care Med. 2013 Feb;41(2):536-45. doi: 10.1097/CCM.0b013e3182711972.
PubMed 23263584Bertoni M, Telias I, Urner M, Long M, Del Sorbo L, Fan E, Sinderby C, Beck J, Liu L, Qiu H, Wong J, Slutsky AS, Ferguson ND, Brochard LJ, Goligher EC. A novel non-invasive method to detect excessively high respiratory effort and dynamic transpulmonary driving pressure during mechanical ventilation. Crit Care. 2019 Nov 6;23(1):346. doi: 10.1186/s13054-019-2617-0.
PubMed 31694692Mascheroni D, Kolobow T, Fumagalli R, Moretti MP, Chen V, Buckhold D. Acute respiratory failure following pharmacologically induced hyperventilation: an experimental animal study. Intensive Care Med. 1988;15(1):8-14. doi: 10.1007/BF00255628.
PubMed 3230208Yoshida T, Torsani V, Gomes S, De Santis RR, Beraldo MA, Costa EL, Tucci MR, Zin WA, Kavanagh BP, Amato MB. Spontaneous effort causes occult pendelluft during mechanical ventilation. Am J Respir Crit Care Med. 2013 Dec 15;188(12):1420-7. doi: 10.1164/rccm.201303-0539OC.
PubMed 24199628Dzierba AL, Khalil AM, Derry KL, Madahar P, Beitler JR. Discordance Between Respiratory Drive and Sedation Depth in Critically Ill Patients Receiving Mechanical Ventilation. Crit Care Med. 2021 Dec 1;49(12):2090-2101. doi: 10.1097/CCM.0000000000005113.
PubMed 34115638Mauri 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 27334266Loring SH, O'Donnell CR, Behazin N, Malhotra A, Sarge T, Ritz R, Novack V, Talmor D. Esophageal pressures in acute lung injury: do they represent artifact or useful information about transpulmonary pressure, chest wall mechanics, and lung stress? J Appl Physiol (1985). 2010 Mar;108(3):515-22. doi: 10.1152/japplphysiol.00835.2009. Epub 2009 Dec 17.
PubMed 20019160
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Respiratory Effort Parameters During the First 48 Hours With Clinical Outcomes in Mechanically Ventilated Patients: A Prospective Observational Study.
- ClinicalTrials.gov ID
- NCT06433076
- Acronym / sponsor ID
- EFFORT-1 / COA. MURA2022/317
- Keywords
- Respiratory effort, Acute respiratory distress syndrome (ARDS), Dynamic transpulmonary pressure swing (Predicted ΔPL), Patient self-inflicted lung injury (P-SILI), Patient ventilator asynchrony (PVA)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Ramathibodi HospitalUniversity, hospital or other
- Study start
- 8 Jun 2022 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 29 May 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.
Over-assisted mechanical ventilation (MV) is linked to respiratory muscle disuse atrophy, while under-assisted MV can lead to patient self-inflicted lung injury (P-SILI) or respiratory muscle injuries. Both scenarios result in poor outcomes. This hypothesis aims to demonstrate the association between the degree of respiratory effort which was measured by P0.1, predicted Pmus, and predicted Δtranspulmonary pressure (ΔPL) with ventilator-free days (VFD) and 28-day mortality.
Detailed description
Recently, the lung and diaphragm protective strategy is an important consideration when providing mechanical ventilation to critically ill patients. Although mechanical ventilation can be life-saving, improper management can cause harm. The harmful mechanical ventilator setting can result from over-assisted or under-assisted ventilation. Over-assisted ventilation can be caused by too much ventilatory support or calming down patients with high dosages of sedative drugs or muscle relaxants, which negatively affect the operation of the diaphragm leading to diaphragm muscle atrophy and weakness. This can make it more difficult to weaning and lead to prolonged use of mechanical ventilation. It appears that previous study found a correlation between percentage change in diaphragm thickness fraction, as measured by ultrasound, during the first week of mechanical ventilation and prolonged duration of mechanical ventilation, extended length of stay in the ICU, and complications. Additionally, in the study conclusions, a diaphragm thickness fraction of 15-30% during the first three days of mechanical ventilation was associated with the shortest duration of mechanical ventilation and this may potentially help guide the management of respiratory support.
On the other hand, the effect of under-assist breathing or allowing excessive respiratory effort could be harmful. Some reported in chronic obstructive pulmonary disease (COPD) exacerbation patients found that the increased negative intra-thoracic pressure potentially causes injury to the diaphragm sarcomeres, which are the muscle fibers responsible for generating force during breathing and it was proportional to the degree of obstruction. And compared light microscopy of the diaphragmatic muscles necropsy in patients who died of COPD with normal subjects. They found muscular necrosis and accumulation of fibrosis and collagen deposits. The cytoplasm was scattered, disrupted, and lipofuscin accumulation with hyper-eosinophilia was observed.
In addition, an excessive high respiratory effort can cause lung injury by patient-self known as patient self-inflicted lung injury (P-SILI), a theory first mentioned that the increased magnitude of negative intrathoracic pressure during inhalation may cause the fluid shift from the pulmonary capillaries to the alveoli causing pulmonary edema. This is relevant to the observational studies that the occurrence of negative intrathoracic pressure during large inhalations in obstruction airway patients, such as tracheal stenosis, also results in pulmonary edema. In latterly confirmed this hypothesis. Subsequent studies have supported this phenomenon and overall could be explained through the increase of transpulmonary pressure, pendelluft phenomenon and patient-ventilator asynchrony (PVA).
However, no current studies determine the relationship between respiratory effort measurement during mechanical ventilation and clinical outcomes. Therefore, we conduct the study to determine the relationship between respiratory effort parameters and clinical outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Preference respiratory effort | – | –The preference respiratory effort group was defined by either 1.5≤P0.1≤3.5 cmH2O, 5≤ predicted Pmus≤10 cmH2O, or predicted ΔPL≤20 cmH2O. |
| Insufficiency respiratory effort | – | –The insufficiency respiratory effort group was defined by either P0.1<1.5 cmH2O or predicted Pmus < 5 cmH2O. |
| Excessive respiratory effort | – | –The excessive respiratory effort group was defined by either P0.1 > 3.5 cmH2O, predicted Pmus > 10 cmH2O, or predicted ΔPL > 20 cmH2O. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A single-center analytical observational prospective study was conducted between June 2022 and April 2024. We enrolled acute respiratory failure patients who required mechanical ventilation from the intensive care units (ICUs) at Ramathibodi Hospital, Mahidol University.
Key inclusion criteria (10 listed)
- Participants must be aged between 18-75 years.
- Admitted to the critical care and semi-critical care units (ICUs) of the Department of -Internal Medicine, Ramathibodi Hospital (ICUs 9IC, 8IK, and 7NW).
- Patients with acute respiratory failure admitted to the hospital with the following conditions within the first 48 hours:
- Permission obtained from the attending physician.
- Research participants or their direct relatives must sign informed consent.
Key exclusion criteria (10 listed)
- Admitted to the hospital or had a history of hospital admission within a month before recruitment.
- History of cardiovascular or cerebrovascular events within the last 12 months.
- Pregnant.
- Terminal-stage cancer patient, terminal illness-stage of disease who desire palliative care.
- Active neurological or muscular disorders affecting stability.
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
28 days ventilator-free days (VFDs)
Time frame: After intubated patients were recruited until successful extubation or dead/failed extubation with in 28 days.
The number of VFDs was defined as the number of days from the last day of mechanical ventilation to day 28. If a patient died during the first 28 days, their number of VFDs is equal to zero.
1 secondary outcome
28 days all-cause mortality
Time frame: After intubated patients were recruited until alive or dead with in 28 days.
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 29 May 2024.
- Background: PubMed 27626706Beduneau G, Pham T, Schortgen F, Piquilloud L, Zogheib E, Jonas M, Grelon F, Runge I, Nicolas Terzi, Grange S, Barberet G, Guitard PG, Frat JP, Constan A, Chretien JM, Mancebo J, Mercat A, Richard JM, Brochard L; WIND (Weaning according to a New Definition) Study Group and the REVA (Reseau Europeen de Recherche en Ventilation Artificielle) Network double dagger. Epidemiology of Weaning Outcome according to a New Definition. The WIND Study. Am J Respir Crit Care Med. 2017 Mar 15;195(6):772-783. doi: 10.1164/rccm.201602-0320OC.
- 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 11719318Orozco-Levi M, Lloreta J, Minguella J, Serrano S, Broquetas JM, Gea J. Injury of the human diaphragm associated with exertion and chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2001 Nov 1;164(9):1734-9. doi: 10.1164/ajrccm.164.9.2011150.
- Background: PubMed 16387935Scott A, Wang X, Road JD, Reid WD. Increased injury and intramuscular collagen of the diaphragm in COPD: autopsy observations. Eur Respir J. 2006 Jan;27(1):51-9. doi: 10.1183/09031936.06.00143004.
- BackgroundLoeb L. The Mechanism in the Development of Pulmonary Edema. Proceedings of the Society for Experimental Biology and Medicine. 1928;25(5):321-323. doi:10.3181/00379727-25-3837
- Background: PubMed 19869306Moore RL, Binger CA. THE RESPONSE TO RESPIRATORY RESISTANCE : A COMPARISON OF THE EFFECTS PRODUCED BY PARTIAL OBSTRUCTION IN THE INSPIRATORY AND EXPIRATORY PHASES OF RESPIRATION. J Exp Med. 1927 May 31;45(6):1065-80. doi: 10.1084/jem.45.6.1065.
- Background: PubMed 16694380Barach AL, Eckman M. THE EFFECTS OF INHALATION OF HELIUM MIXED WITH OXYGEN ON THE MECHANICS OF RESPIRATION. J Clin Invest. 1936 Jan;15(1):47-61. doi: 10.1172/JCI100758. No abstract available.
- Background: PubMed 3057957Dreyfuss D, Soler P, Basset G, Saumon G. High inflation pressure pulmonary edema. Respective effects of high airway pressure, high tidal volume, and positive end-expiratory pressure. Am Rev Respir Dis. 1988 May;137(5):1159-64. doi: 10.1164/ajrccm/137.5.1159.
- Background: PubMed 23263584Yoshida T, Uchiyama A, Matsuura N, Mashimo T, Fujino Y. The comparison of spontaneous breathing and muscle paralysis in two different severities of experimental lung injury. Crit Care Med. 2013 Feb;41(2):536-45. doi: 10.1097/CCM.0b013e3182711972.
- Background: PubMed 31694692Bertoni M, Telias I, Urner M, Long M, Del Sorbo L, Fan E, Sinderby C, Beck J, Liu L, Qiu H, Wong J, Slutsky AS, Ferguson ND, Brochard LJ, Goligher EC. A novel non-invasive method to detect excessively high respiratory effort and dynamic transpulmonary driving pressure during mechanical ventilation. Crit Care. 2019 Nov 6;23(1):346. doi: 10.1186/s13054-019-2617-0.
- Results publication: PubMed 3230208Mascheroni D, Kolobow T, Fumagalli R, Moretti MP, Chen V, Buckhold D. Acute respiratory failure following pharmacologically induced hyperventilation: an experimental animal study. Intensive Care Med. 1988;15(1):8-14. doi: 10.1007/BF00255628.
- Results publication: PubMed 24199628Yoshida T, Torsani V, Gomes S, De Santis RR, Beraldo MA, Costa EL, Tucci MR, Zin WA, Kavanagh BP, Amato MB. Spontaneous effort causes occult pendelluft during mechanical ventilation. Am J Respir Crit Care Med. 2013 Dec 15;188(12):1420-7. doi: 10.1164/rccm.201303-0539OC.
- Individual participant dataSharing planned: Undecided
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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.
Mr. Phruet Soipetkasem, Critical care doctor principal investigator
Doctor of Critical care medicine Ramathibodi hospital
Pongdhep Theerawit, Assoc. Prof. study chair
Head of Critical care medicine Ramathibodi hospital
Yuda Sutherasan, Assoc. Prof. study director
Clinical professor of Pulmonary and Critical care medicine Ramathibodi hospital
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 Respiratory Effort and Respiratory Distress Syndrome, run by Ramathibodi Hospital at 1 site in Thailand.
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 10 inclusion and 10 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 29 May 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 Thailand. 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?
28 days ventilator-free days (VFDs) (time frame: After intubated patients were recruited until successful extubation or dead/failed extubation with in 28 days.). 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 NCT06433076, which also lists 18 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 29 May 2024.