Weaning FailureNCT05802745
P0.1 and Extubation Failure in Critically Ill Patients
An observational study of Weaning Failure and Mechanical Ventilation, run by Cleveland Clinic Abu Dhabi at 2 sites in France.
Trial summary
Weaning and extubation are essential steps for the management of critically ill patients when mechanical ventilation (MV) is no longer required. Extubation failure (EF) occurs in approximately 10-30% (1,2) of all patients meeting the readiness criteria and have tolerated a spontaneous breathing trial (SBT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weaning Failure, Mechanical Ventilation, Critically Ill
- What is being tested?
- Reintubation
- How many people
- 120 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Jun 2023to 30 Aug 2025
- 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: Critically ill patients with invasive mechanical ventilation.
Who may be able to join
- All patients aged 18 years or older who received mechanical ventilation for at least 48 hours and satisfied the weaning criteria will be eligible for enrollment.
- The readiness-to-wean criteria that will be employed are: (1) the resolution or improvement of the underlying cause of respiratory failure for which the patient was intubated; (2) hemodynamic stability, defined as heart rate (HR) < 140/min and systolic blood pressure between 90 and 160 mmHg with no or minimal doses of vasopressors; (3) stable respiratory status, defined as oxygen saturation > 90% with fraction of inspired oxygen (FiO2) ≤ 0.5 and positive end expiratory-pressure (PEEP) ≤8 cmH2O, respiratory rate (RR) ≤ 35/min, spontaneous tidal volume (Vt) > 5 mL/kg, and no significant respiratory acidosis; (4) adequate mental status, and (5) adequate cough.
Who cannot join
- Presence of tracheostomy
- Do-not-reintubate orders
- pregnancy
- Absence of informed consent
- Spontaneous breathing trial failure.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Airway Occlusion Pressure (P0.1) to Predict Extubation Failure in Critically Ill Patients: A Prospective Cohort Study
Weaning and extubation are essential steps for the management of critically ill patients when mechanical ventilation (MV) is no longer required. Extubation failure (EF) occurs in approximately 10-30% (1,2) of all patients meeting the readiness criteria and have tolerated a spontaneous breathing trial (SBT). EF is associated with prolonged MV, as well as increased morbidity and mortality (2). Therefore, the early identification of critically ill patients who are likely to experience EF is vital for improved outcomes.
EF can result from different factors (respiratory, metabolic, neuromuscular), particularly cardiac factor, and can be caused by the inability of the respiratory muscle pump to tolerate increases in the cardiac and respiratory load (1,3).
Read more
Respiratory drive represents the intensity of the neural stimulus to breathe. In mechanically ventilated patients, it can be abnormally low (i.e., suppressed or insufficient) or abnormally high (i.e., excessive), and thus result in excessively low or high inspiratory effort, leading to potential injury to the respiratory muscles (i.e., myotrauma) (4,5) or to the lungs. A high incidence of abnormal drive (low or high) may explain the high incidence of diaphragm dysfunction at time of separation from mechanical ventilation (6).
Airway occlusion pressure (P0.1) is the drop in airway pressure (Paw) 100 milliseconds after the onset of inspiration during an end-expiratory occlusion of the airway (7). P0.1 measurement is not perceived by the patient and does not influence respiratory pattern. It is, in theory, a reliable measure of respiratory drive because the brevity of the occlusion explains that it is not affected by patient's response to the occlusion and it is independent of respiratory mechanics (8). P0.1 has also been correlated with inspiratory effort (9, 10) and it has been shown that in patients under assisted mechanical ventilation P0.1 might be able to detect potentially excessive inspiratory effort (11).
P0.1 is a non-invasive measure and clinically available at bedside since currently nearly all modern ventilators provide a means of measuring it. Originally, a high P0.1 during a spontaneous breathing trial was associated with failure, suggesting that a high respiratory drive could predict weaning failure. However, only a few and old clinical studies investigated the association between P0.1 and extubation failure (EF) and were not conclusive (12,13). We hypothesized that patients with EF would have increased P0.1 values during spontaneous breathing trial (SBT). Therefore, the aims of our study will be to (1) to evaluate the ability of changes in P0.1 (Delta-P0.1) during SBT to predict EF and (2) to assess if Delta-P0.1 is an independent predictor of EF.
Read the detailed description
Weaning protocol SBTs will be performed in semirecumbent patients on Pressure Support Ventilation (PSV) mode with inspiratory pressure of 5 cmH2O and positive-end-expiratory pressure (PEEP) of 5 cmH2O as per ICU protocol. Inspiratory oxygen fraction (FiO2) will be adjusted for the achievement of an arterial oxygen saturation value > 90%, as measured by pulse oximetry. The SBT duration will be 30 minutes as per ICU protocol. The criteria that will be used for poor SBT tolerance are: (1) diaphoresis; (2) use of accessory respiratory muscles; (3) RR > 35/min; (4) oxygen saturation by pulse oximetry < 90% with FiO2 ≥ 50%; (5) HR > 140/min or greater than a 20% increase from baseline; (6) Systolic blood pressure >180 mmHg or <90 mmHg; (7) development of cardiac arrhythmias; and/or low level of consciousness.
The decision to stop SBT will be made by the physicians. Patients who will fail SBT will be shifted to their previous ventilator mode and not be enrolled in the study.
Patients who will complete the SBT will be extubated and followed-up for 72 hours. The medical team (physician, nurse, and respiratory therapist) involved in the extubation decision will be blinded to the P0.1 results. EF will be diagnosed if the patient is extubated but required reintubation within the following 72 hours. Criteria for acute respiratory failure after extubation are the development of at least one of the following: (a) respiratory acidosis with pH < 7.32 and arterial CO2 pressure (PaCO2) > 45 mmHg; (b) arterial oxygen saturation < 90% with FiO2 > 0.5; (c) RR > 35/min; (d) clinical signs of respiratory fatigue.
The management of post-extubation respiratory failure will not be protocolized and will be left to the physician's discretion.
Ventilatory, including P0.1 and hemodynamic parameters, including EtCO2 will be recorded as the average of at least three measurements immediately before SBT, during SBT, and at 30 minutes after SBT initiation. Arterial and central venous blood gas (if central line present) will be measured immediately before SBT and at 30 minutes after SBT initiation.
- Conditions
- Weaning Failure, Mechanical Ventilation, Critically Ill
- Being tested
- Reintubation
- Keywords
- Airway occlusion pressure, Extubation failure, Critically Ill patients, Weaning, Mechanical ventilation
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReintubationOther
Patients requiring re-intubation for acute respiratory failure.
| Study group | Role | What they receive |
|---|---|---|
| Extubation failure | Patients who will require to be re-intubated within 72 hours after extubation. Receives: Other: Reintubation | |
| Extubation success | Patients who will not require reintubation within 72 hours of extubation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extubation failure
to evaluate the ability of changes in P01 (Delta-P0.1) during SBT to predict extubation failure after 72 hours of extubation.
Measured: Within 72 hours after extubation.
Secondary outcomes (2)
Delta-P01 as independent factor of extubation failure
To assess if Delta- P0.1 during SBT is an independent predictor of extubation failure
Measured: Within 72 hours after extubation.
Extubation failure
Association between Delta-P0.1 and extubation failure after 7 days of extubation
Measured: 7 days after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start1 Jun 2023
- Primary completion25 May 2024
- Study completion30 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Weaning 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cleveland Clinic Abu Dhabi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jihad Mallat, Cleveland Clinic Abu Dhabi
- Investigators
- Jihad Mallat, MD, PhD, Principal investigator, Cleveland Clinic Abu Dhabi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05802745
- Sponsor's protocol ID
- A-2023-014
- Status last verified
- Mar 2023
- First submitted
- 25 Mar 2023
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Boles JM, Bion J, Connors A, Herridge M, Marsh B, Melot C, Pearl R, Silverman H, Stanchina M, Vieillard-Baron A, Welte T. Weaning from mechanical ventilation. Eur Respir J. 2007 May;29(5):1033-56. doi: 10.1183/09031936.00010206.
PubMed 17470624Thille AW, Richard JC, Brochard L. The decision to extubate in the intensive care unit. Am J Respir Crit Care Med. 2013 Jun 15;187(12):1294-302. doi: 10.1164/rccm.201208-1523CI.
PubMed 23641924MacIntyre N. Discontinuing mechanical ventilatory support. Chest. 2007 Sep;132(3):1049-56. doi: 10.1378/chest.06-2862.
PubMed 17873200Goligher 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 28930478Goligher 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 30455078Dres M, Dube BP, Mayaux J, Delemazure J, Reuter D, Brochard L, Similowski T, Demoule A. Coexistence and Impact of Limb Muscle and Diaphragm Weakness at Time of Liberation from Mechanical Ventilation in Medical Intensive Care Unit Patients. Am J Respir Crit Care Med. 2017 Jan 1;195(1):57-66. doi: 10.1164/rccm.201602-0367OC.
PubMed 27310484Telias I, Damiani F, Brochard L. The airway occlusion pressure (P0.1) to monitor respiratory drive during mechanical ventilation: increasing awareness of a not-so-new problem. Intensive Care Med. 2018 Sep;44(9):1532-1535. doi: 10.1007/s00134-018-5045-8. Epub 2018 Jan 19. No abstract available.
PubMed 29350241Whitelaw WA, Derenne JP, Milic-Emili J. Occlusion pressure as a measure of respiratory center output in conscious man. Respir Physiol. 1975 Mar;23(2):181-99. doi: 10.1016/0034-5687(75)90059-6.
PubMed 1144940Alberti A, Gallo F, Fongaro A, Valenti S, Rossi A. P0.1 is a useful parameter in setting the level of pressure support ventilation. Intensive Care Med. 1995 Jul;21(7):547-53. doi: 10.1007/BF01700158.
PubMed 7593895Mancebo J, Albaladejo P, Touchard D, Bak E, Subirana M, Lemaire F, Harf A, Brochard L. Airway occlusion pressure to titrate positive end-expiratory pressure in patients with dynamic hyperinflation. Anesthesiology. 2000 Jul;93(1):81-90. doi: 10.1097/00000542-200007000-00016.
PubMed 10861149Rittayamai N, Beloncle F, Goligher EC, Chen L, Mancebo J, Richard JM, Brochard L. Effect of inspiratory synchronization during pressure-controlled ventilation on lung distension and inspiratory effort. Ann Intensive Care. 2017 Oct 6;7(1):100. doi: 10.1186/s13613-017-0324-z.
PubMed 28986852Sassoon CS, Te TT, Mahutte CK, Light RW. Airway occlusion pressure. An important indicator for successful weaning in patients with chronic obstructive pulmonary disease. Am Rev Respir Dis. 1987 Jan;135(1):107-13. doi: 10.1164/arrd.1987.135.1.107.
PubMed 3800139Fernandez R, Raurich JM, Mut T, Blanco J, Santos A, Villagra A. Extubation failure: diagnostic value of occlusion pressure (P0.1) and P0.1-derived parameters. Intensive Care Med. 2004 Feb;30(2):234-240. doi: 10.1007/s00134-003-2070-y. Epub 2003 Nov 8.
PubMed 14608459Mallat J, Storme N, Askalany M, Helal M, Din MU, Samanta S, Samanta S, Hamed F, Edke U, Carvalho T, De Oliveira B, Elkambergy H, Dibu J, Bayrlee A, Siddique H, Haque R, Aljaberi N, Shoshan S, Munde D, Guilbart M, Dhundi U, Alhajri N, Babar M, Taha A, Belfegas M, Mandi A, Khan U, Ahmed I, Omer T, Varghese Y, Ghisulal P, Metzelard M, Kakar V, Charles A, Kacherintavida M, Mali CE, Beyls C, Venkatarmireddy S, Amte R, Aljasmi M, Abduljawad B, Ismail K, Mahjoub Y, Arab OA. Reliability of airway occlusion pressure (P0.1) in predicting extubation failure in critically ill patients. J Intensive Med. 2026 Feb 19;6(4):374-381. doi: 10.1016/j.jointm.2026.01.001. eCollection 2026 Aug.
PubMed 42396234Mallat J, Storme N, Askalany M, Helal M, Din MU, Samanta S, Samanta S, Hamed F, Edke U, Carvalho T, De Oliveira B, Elkambergy H, Dibu J, Bayrlee A, Siddique H, Haque R, Aljaberi N, Shoshan S, Munde D, Guilbart M, Dhundi U, Alhajri N, Babar M, Belfegas M, Mandi A, Khan U, Ahmed I, Omer T, Varghese Y, Metzelard M, Charles A, Kacherintavida M, Beyls C, Aljasmi M, Abduljawad B, Ismail K, Mahjoub Y, Abou Arab O. The Weaning Index during Spontaneous Breathing Trials for Predicting Extubation Failure in Critically Ill Patients: A Bicentric Prospective Study. Anaesth Crit Care Pain Med. 2026 Mar 20:101819. doi: 10.1016/j.accpm.2026.101819. Online ahead of print.
PubMed 41866025
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Airway Occlusion Pressure (P0.1) to Predict Extubation Failure in Critically Ill Patients: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05802745
- Acronym / sponsor ID
- A-2023-014
- Conditions
- Weaning Failure, Mechanical Ventilation, Critically Ill
- Keywords
- Airway occlusion pressure, Extubation failure, Critically Ill patients, Weaning, Mechanical ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Cleveland Clinic Abu DhabiUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 25 May 2024 (actual)
- Study completion
- 30 Aug 2025 (actual)
- First posted
- 7 Apr 2023 (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.
Weaning and extubation are essential steps for the management of critically ill patients when mechanical ventilation (MV) is no longer required. Extubation failure (EF) occurs in approximately 10-30% (1,2) of all patients meeting the readiness criteria and have tolerated a spontaneous breathing trial (SBT). EF is associated with prolonged MV, as well as increased morbidity and mortality (2). Therefore, the early identification of critically ill patients who are likely to experience EF is vital for improved outcomes.
EF can result from different factors (respiratory, metabolic, neuromuscular), particularly cardiac factor, and can be caused by the inability of the respiratory muscle pump to tolerate increases in the cardiac and respiratory load (1,3).
Respiratory drive represents the intensity of the neural stimulus to breathe. In mechanically ventilated patients, it can be abnormally low (i.e., suppressed or insufficient) or abnormally high (i.e., excessive), and thus result in excessively low or high inspiratory effort, leading to potential injury to the respiratory muscles (i.e., myotrauma) (4,5) or to the lungs. A high incidence of abnormal drive (low or high) may explain the high incidence of diaphragm dysfunction at time of separation from mechanical ventilation (6).
Airway occlusion pressure (P0.1) is the drop in airway pressure (Paw) 100 milliseconds after the onset of inspiration during an end-expiratory occlusion of the airway (7). P0.1 measurement is not perceived by the patient and does not influence respiratory pattern. It is, in theory, a reliable measure of respiratory drive because the brevity of the occlusion explains that it is not affected by patient's response to the occlusion and it is independent of respiratory mechanics (8). P0.1 has also been correlated with inspiratory effort (9, 10) and it has been shown that in patients under assisted mechanical ventilation P0.1 might be able to detect potentially excessive inspiratory effort (11).
P0.1 is a non-invasive measure and clinically available at bedside since currently nearly all modern ventilators provide a means of measuring it. Originally, a high P0.1 during a spontaneous breathing trial was associated with failure, suggesting that a high respiratory drive could predict weaning failure. However, only a few and old clinical studies investigated the association between P0.1 and extubation failure (EF) and were not conclusive (12,13). We hypothesized that patients with EF would have increased P0.1 values during spontaneous breathing trial (SBT). Therefore, the aims of our study will be to (1) to evaluate the ability of changes in P0.1 (Delta-P0.1) during SBT to predict EF and (2) to assess if Delta-P0.1 is an independent predictor of EF.
Detailed description
Weaning protocol SBTs will be performed in semirecumbent patients on Pressure Support Ventilation (PSV) mode with inspiratory pressure of 5 cmH2O and positive-end-expiratory pressure (PEEP) of 5 cmH2O as per ICU protocol. Inspiratory oxygen fraction (FiO2) will be adjusted for the achievement of an arterial oxygen saturation value > 90%, as measured by pulse oximetry. The SBT duration will be 30 minutes as per ICU protocol. The criteria that will be used for poor SBT tolerance are: (1) diaphoresis; (2) use of accessory respiratory muscles; (3) RR > 35/min; (4) oxygen saturation by pulse oximetry < 90% with FiO2 ≥ 50%; (5) HR > 140/min or greater than a 20% increase from baseline; (6) Systolic blood pressure >180 mmHg or <90 mmHg; (7) development of cardiac arrhythmias; and/or low level of consciousness.
The decision to stop SBT will be made by the physicians. Patients who will fail SBT will be shifted to their previous ventilator mode and not be enrolled in the study.
Patients who will complete the SBT will be extubated and followed-up for 72 hours. The medical team (physician, nurse, and respiratory therapist) involved in the extubation decision will be blinded to the P0.1 results. EF will be diagnosed if the patient is extubated but required reintubation within the following 72 hours. Criteria for acute respiratory failure after extubation are the development of at least one of the following: (a) respiratory acidosis with pH < 7.32 and arterial CO2 pressure (PaCO2) > 45 mmHg; (b) arterial oxygen saturation < 90% with FiO2 > 0.5; (c) RR > 35/min; (d) clinical signs of respiratory fatigue.
The management of post-extubation respiratory failure will not be protocolized and will be left to the physician's discretion.
Ventilatory, including P0.1 and hemodynamic parameters, including EtCO2 will be recorded as the average of at least three measurements immediately before SBT, during SBT, and at 30 minutes after SBT initiation. Arterial and central venous blood gas (if central line present) will be measured immediately before SBT and at 30 minutes after SBT initiation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extubation failure | – | Other: ReintubationPatients who will require to be re-intubated within 72 hours after extubation. |
| Extubation success | – | –Patients who will not require reintubation within 72 hours of extubation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients with invasive mechanical ventilation.
Key inclusion criteria (2 listed)
- All patients aged 18 years or older who received mechanical ventilation for at least 48 hours and satisfied the weaning criteria will be eligible for enrollment.
- The readiness-to-wean criteria that will be employed are: (1) the resolution or improvement of the underlying cause of respiratory failure for which the patient was intubated; (2) hemodynamic stability, defined as heart rate (HR) < 140/min and systolic blood pressure between 90 and 160 mmHg with no or minimal doses of vasopressors; (3) stable respiratory status, defined as oxygen saturation > 90% with fraction of inspired oxygen (FiO2) ≤ 0.5 and positive end expiratory-pressure (PEEP) ≤8 cmH2O, respiratory rate (RR) ≤ 35/min, spontaneous tidal volume (Vt) > 5 mL/kg, and no significant respiratory acidosis; (4) adequate mental status, and (5) adequate cough.
Key exclusion criteria (5 listed)
- Presence of tracheostomy
- Do-not-reintubate orders
- pregnancy
- Absence of informed consent
- Spontaneous breathing trial failure.
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 |
|---|---|---|
| ReintubationPatients requiring re-intubation for acute respiratory failure. | Other | Extubation failure |
Primary outcome
Extubation failure
Time frame: Within 72 hours after extubation.
to evaluate the ability of changes in P01 (Delta-P0.1) during SBT to predict extubation failure after 72 hours of extubation.
2 secondary outcomes
Delta-P01 as independent factor of extubation failure
Time frame: Within 72 hours after extubation.
Extubation failure
Time frame: 7 days after extubation
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 19 May 2026.
- Results publication: PubMed 17470624Boles JM, Bion J, Connors A, Herridge M, Marsh B, Melot C, Pearl R, Silverman H, Stanchina M, Vieillard-Baron A, Welte T. Weaning from mechanical ventilation. Eur Respir J. 2007 May;29(5):1033-56. doi: 10.1183/09031936.00010206.
- Results publication: PubMed 23641924Thille AW, Richard JC, Brochard L. The decision to extubate in the intensive care unit. Am J Respir Crit Care Med. 2013 Jun 15;187(12):1294-302. doi: 10.1164/rccm.201208-1523CI.
- Results publication: PubMed 17873200MacIntyre N. Discontinuing mechanical ventilatory support. Chest. 2007 Sep;132(3):1049-56. doi: 10.1378/chest.06-2862.
- Results publication: 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.
- Results publication: 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.
- Results publication: PubMed 27310484Dres M, Dube BP, Mayaux J, Delemazure J, Reuter D, Brochard L, Similowski T, Demoule A. Coexistence and Impact of Limb Muscle and Diaphragm Weakness at Time of Liberation from Mechanical Ventilation in Medical Intensive Care Unit Patients. Am J Respir Crit Care Med. 2017 Jan 1;195(1):57-66. doi: 10.1164/rccm.201602-0367OC.
- Results publication: PubMed 29350241Telias I, Damiani F, Brochard L. The airway occlusion pressure (P0.1) to monitor respiratory drive during mechanical ventilation: increasing awareness of a not-so-new problem. Intensive Care Med. 2018 Sep;44(9):1532-1535. doi: 10.1007/s00134-018-5045-8. Epub 2018 Jan 19. No abstract available.
- Results publication: PubMed 1144940Whitelaw WA, Derenne JP, Milic-Emili J. Occlusion pressure as a measure of respiratory center output in conscious man. Respir Physiol. 1975 Mar;23(2):181-99. doi: 10.1016/0034-5687(75)90059-6.
- Results publication: PubMed 7593895Alberti A, Gallo F, Fongaro A, Valenti S, Rossi A. P0.1 is a useful parameter in setting the level of pressure support ventilation. Intensive Care Med. 1995 Jul;21(7):547-53. doi: 10.1007/BF01700158.
- Results publication: PubMed 10861149Mancebo J, Albaladejo P, Touchard D, Bak E, Subirana M, Lemaire F, Harf A, Brochard L. Airway occlusion pressure to titrate positive end-expiratory pressure in patients with dynamic hyperinflation. Anesthesiology. 2000 Jul;93(1):81-90. doi: 10.1097/00000542-200007000-00016.
- Results publication: PubMed 28986852Rittayamai N, Beloncle F, Goligher EC, Chen L, Mancebo J, Richard JM, Brochard L. Effect of inspiratory synchronization during pressure-controlled ventilation on lung distension and inspiratory effort. Ann Intensive Care. 2017 Oct 6;7(1):100. doi: 10.1186/s13613-017-0324-z.
- Results publication: PubMed 3800139Sassoon CS, Te TT, Mahutte CK, Light RW. Airway occlusion pressure. An important indicator for successful weaning in patients with chronic obstructive pulmonary disease. Am Rev Respir Dis. 1987 Jan;135(1):107-13. doi: 10.1164/arrd.1987.135.1.107.
- 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.
Jihad Mallat, MD, PhD principal investigator
Cleveland Clinic Abu Dhabi
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Weaning Failure and Mechanical Ventilation, run by Cleveland Clinic Abu Dhabi at 2 sites in France.
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 2 inclusion and 5 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 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
Extubation failure (time frame: Within 72 hours after extubation.). 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 NCT05802745, which also lists 15 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 19 May 2026.