NCT02450669

Brief Summary

Airway management in intensive care unit (ICU) patients is challenging. Benefit risk ratio of extubation has to be daily assessed in intubated patients. The investigators aimed to assess incidence and risk factors of airway failure after extubation procedure in critically ill patients in a prospective multicenter study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
417

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 19, 2013

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 18, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 21, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 4, 2015

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2015

Completed
Last Updated

April 21, 2017

Status Verified

March 1, 2017

Enrollment Period

1.5 years

First QC Date

May 18, 2015

Last Update Submit

April 20, 2017

Conditions

Keywords

IntubationExtubationWeaningMechanical ventilation

Outcome Measures

Primary Outcomes (1)

  • Risk factors of airway failure (logistic regression will be used to identify risk factors)

    48 hours

Secondary Outcomes (1)

  • Risf factors of extubation failure and weaning failure (Quantitative variables will be expressed as means (standard deviation) or medians (interquartiles 25%-75%) and compared using the student t test or the Wilcoxon test as appropriate

    48 hours

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All the adult patients extubated in the ICU

You may qualify if:

  • Adult patient extubated in the ICU

You may not qualify if:

  • Decision not to reintubate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Montpellier

Montpellier, 34090, France

Location

Related Publications (18)

  • Marini JJ, Smith TC, Lamb VJ. External work output and force generation during synchronized intermittent mechanical ventilation. Effect of machine assistance on breathing effort. Am Rev Respir Dis. 1988 Nov;138(5):1169-79. doi: 10.1164/ajrccm/138.5.1169.

  • Moschietto S, Doyen D, Grech L, Dellamonica J, Hyvernat H, Bernardin G. Transthoracic Echocardiography with Doppler Tissue Imaging predicts weaning failure from mechanical ventilation: evolution of the left ventricle relaxation rate during a spontaneous breathing trial is the key factor in weaning outcome. Crit Care. 2012 May 14;16(3):R81. doi: 10.1186/cc11339.

  • Montgomery AB, Holle RH, Neagley SR, Pierson DJ, Schoene RB. Prediction of successful ventilator weaning using airway occlusion pressure and hypercapnic challenge. Chest. 1987 Apr;91(4):496-9. doi: 10.1378/chest.91.4.496.

  • Epstein SK, Ciubotaru RL. Independent effects of etiology of failure and time to reintubation on outcome for patients failing extubation. Am J Respir Crit Care Med. 1998 Aug;158(2):489-93. doi: 10.1164/ajrccm.158.2.9711045.

  • Witt NJ, Zochodne DW, Bolton CF, Grand'Maison F, Wells G, Young GB, Sibbald WJ. Peripheral nerve function in sepsis and multiple organ failure. Chest. 1991 Jan;99(1):176-84. doi: 10.1378/chest.99.1.176.

  • Ely EW, Shintani A, Truman B, Speroff T, Gordon SM, Harrell FE Jr, Inouye SK, Bernard GR, Dittus RS. Delirium as a predictor of mortality in mechanically ventilated patients in the intensive care unit. JAMA. 2004 Apr 14;291(14):1753-62. doi: 10.1001/jama.291.14.1753.

  • Annane D, Sebille V, Charpentier C, Bollaert PE, Francois B, Korach JM, Capellier G, Cohen Y, Azoulay E, Troche G, Chaumet-Riffaud P, Bellissant E. Effect of treatment with low doses of hydrocortisone and fludrocortisone on mortality in patients with septic shock. JAMA. 2002 Aug 21;288(7):862-71. doi: 10.1001/jama.288.7.862.

  • 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.

  • Epstein SK, Ciubotaru RL, Wong JB. Effect of failed extubation on the outcome of mechanical ventilation. Chest. 1997 Jul;112(1):186-92. doi: 10.1378/chest.112.1.186.

  • Rothaar RC, Epstein SK. Extubation failure: magnitude of the problem, impact on outcomes, and prevention. Curr Opin Crit Care. 2003 Feb;9(1):59-66. doi: 10.1097/00075198-200302000-00011.

  • Francon D, Jaber S, Pean D, Bally B, Marciniak B. [Difficult extubation: extubation criteria and management of risk situations: question 6. Societe Francaise d'Anesthesie et de Reanimation]. Ann Fr Anesth Reanim. 2008 Jan;27(1):46-53. doi: 10.1016/j.annfar.2007.10.026. Epub 2007 Dec 31. No abstract available. French.

  • Jaber S, Chanques G, Matecki S, Ramonatxo M, Vergne C, Souche B, Perrigault PF, Eledjam JJ. Post-extubation stridor in intensive care unit patients. Risk factors evaluation and importance of the cuff-leak test. Intensive Care Med. 2003 Jan;29(1):69-74. doi: 10.1007/s00134-002-1563-4. Epub 2002 Nov 22.

  • Tanaka A, Isono S, Ishikawa T, Nishino T. Laryngeal reflex before and after placement of airway interventions: endotracheal tube and laryngeal mask airway. Anesthesiology. 2005 Jan;102(1):20-5. doi: 10.1097/00000542-200501000-00007.

  • Jaber S, Jung B, Matecki S, Petrof BJ. Clinical review: ventilator-induced diaphragmatic dysfunction--human studies confirm animal model findings! Crit Care. 2011 Mar 11;15(2):206. doi: 10.1186/cc10023.

  • Jaber S, Petrof BJ, Jung B, Chanques G, Berthet JP, Rabuel C, Bouyabrine H, Courouble P, Koechlin-Ramonatxo C, Sebbane M, Similowski T, Scheuermann V, Mebazaa A, Capdevila X, Mornet D, Mercier J, Lacampagne A, Philips A, Matecki S. Rapidly progressive diaphragmatic weakness and injury during mechanical ventilation in humans. Am J Respir Crit Care Med. 2011 Feb 1;183(3):364-71. doi: 10.1164/rccm.201004-0670OC. Epub 2010 Sep 2.

  • Aarab Y, Pensier J, Garnier F, Monet C, Lakbar I, Chanques G, de Jong A, Capdevila M, Jaber S; FreeRea study group. Incidence and outcomes of extubation failure in mechanically ventilated patients with cirrhosis: a post-hoc analysis of a prospective multicenter study. Ann Intensive Care. 2025 Oct 16;15(1):160. doi: 10.1186/s13613-025-01576-3.

  • De Jong A, Capdevila M, Aarab Y, Cros M, Pensier J, Lakbar I, Monet C, Quintard H, Cinotti R, Asehnoune K, Arnal JM, Guitton C, Paugam-Burtz C, Abback P, Mekontso-Dessap A, Lakhal K, Lasocki S, Plantefeve G, Claud B, Pottecher J, Corne P, Ichai C, Molinari N, Chanques G, Papazian L, Azoulay E, Jaber S; FREE-REA Study Group. Incidence, Risk Factors, and Long-Term Outcomes for Extubation Failure in ICU in Patients With Obesity: A Retrospective Analysis of a Multicenter Prospective Observational Study. Chest. 2025 Jan;167(1):139-151. doi: 10.1016/j.chest.2024.07.171. Epub 2024 Sep 7.

  • Jaber S, Quintard H, Cinotti R, Asehnoune K, Arnal JM, Guitton C, Paugam-Burtz C, Abback P, Mekontso Dessap A, Lakhal K, Lasocki S, Plantefeve G, Claud B, Pottecher J, Corne P, Ichai C, Hajjej Z, Molinari N, Chanques G, Papazian L, Azoulay E, De Jong A. Risk factors and outcomes for airway failure versus non-airway failure in the intensive care unit: a multicenter observational study of 1514 extubation procedures. Crit Care. 2018 Sep 23;22(1):236. doi: 10.1186/s13054-018-2150-6.

Study Officials

  • Samir JABER, PU-PH

    Hospital of Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2015

First Posted

May 21, 2015

Study Start

December 19, 2013

Primary Completion

July 4, 2015

Study Completion

July 30, 2015

Last Updated

April 21, 2017

Record last verified: 2017-03

Locations