Incidence and Risk Factors of Weaning-induced Cardiac Dysfunction: Results From a Multicenter, Observational Study

NCT05318261 | Completed

• 1 other identifier: 2017-A00392-51
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

During weaning from mechanical ventilation, the shift from positive to negative pressure ventilation may be responsible for a cardiac dysfunction that can lead to the development of pulmonary oedema (weaning-induced pulmonary oedema, WIPO) and to the failure of spontaneous breathing trials. However, the incidence and risk factors for WIPO development are not well defined and have been investigated only by a few studies.

Conditions

Weaning Failure; Weaning-induced Pulmonary Edema; Spontaneous Breathing Trial

Outcome Measures

Primary Outcomes (1)

• The incidence of WIPO

  The diagnosis of WIPO will be done a posteriori by a group of experts. They will establish the diagnosis of WIPO, based on the following elements: * Failure or success of SBT * Clinical examination at the end of SBT * Variation during SBT of arterial blood gas variables, plasmatic protein and blood haemoglobin concentration, extravascular lung water (optional), B-type natriuretic peptide (optional), echocardiographic estimation of left ventricular preload (E and A waves of mitral flow, e' wave of the mitral valve annulus), pulmonary arterial occlusion pressure (optional).

  30-120 mins during the Spontaneous Breathing Trial

Secondary Outcomes (1)

• Risk factors for developing WIPO

  The risk factors for WIPO will be done a posteriori by multivaraite analysis

Interventions

Spontaneous breathing trial PROCEDURE

A spontaneous breathing trial (SBT) is used to identify patients who are likely to fail liberation from mechanical ventilation. The test can be done according to the usual modalities of the participating centre, following the international recommendations, meaning either by disconnecting the endotracheal tube from the ventilator and connecting it to a source of oxygen through the T-tube or by setting pressure support with low positive end-expiratory pressure (PEEP). The choice of the method will not be determined according to the participation in this study but will be done according to the habits of the participating centre.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All the intubated patients who need to do a Spontaneous Breathing Trial

You may qualify if:

• Age ≥ 18 years.
• Social coverage from health insurance (in France).
• Decision of the attending physicians to perform an SBT.

You may not qualify if:

• Presence of tracheostomy (in this case at the end of the test the patient could be connected to the ventilator, even in case of positivity of the weaning test. Thus, it is not possible to test the absence of reintubation at 48 hours, which is one of the criteria defining the success of weaning).
• Refusal of the patient or, if the case, one of the relatives to participate to the study.

Sponsors & Collaborators

• Bicetre Hospital: lead

Study Sites (1)

Medical Intensive Care Unit

Le Kremlin-Bicêtre, France

Location

Related Publications (13)

• Dres M, Teboul JL, Monnet X. Weaning the cardiac patient from mechanical ventilation. Curr Opin Crit Care. 2014 Oct;20(5):493-8. doi: 10.1097/MCC.0000000000000131.

  PMID: 25159477 RESULT

• Teboul JL. Weaning-induced cardiac dysfunction: where are we today? Intensive Care Med. 2014 Aug;40(8):1069-79. doi: 10.1007/s00134-014-3334-4. Epub 2014 May 27.

  PMID: 24861350 RESULT

• Lemaire F, Teboul JL, Cinotti L, Giotto G, Abrouk F, Steg G, Macquin-Mavier I, Zapol WM. Acute left ventricular dysfunction during unsuccessful weaning from mechanical ventilation. Anesthesiology. 1988 Aug;69(2):171-9. doi: 10.1097/00000542-198808000-00004.

  PMID: 3044189 RESULT

• Liu J, Shen F, Teboul JL, Anguel N, Beurton A, Bezaz N, Richard C, Monnet X. Cardiac dysfunction induced by weaning from mechanical ventilation: incidence, risk factors, and effects of fluid removal. Crit Care. 2016 Nov 12;20(1):369. doi: 10.1186/s13054-016-1533-9.

  PMID: 27836002 RESULT

• Lamia B, Maizel J, Ochagavia A, Chemla D, Osman D, Richard C, Teboul JL. Echocardiographic diagnosis of pulmonary artery occlusion pressure elevation during weaning from mechanical ventilation. Crit Care Med. 2009 May;37(5):1696-701. doi: 10.1097/CCM.0b013e31819f13d0.

  PMID: 19325473 RESULT

• Grasso S, Leone A, De Michele M, Anaclerio R, Cafarelli A, Ancona G, Stripoli T, Bruno F, Pugliese P, Dambrosio M, Dalfino L, Di Serio F, Fiore T. Use of N-terminal pro-brain natriuretic peptide to detect acute cardiac dysfunction during weaning failure in difficult-to-wean patients with chronic obstructive pulmonary disease. Crit Care Med. 2007 Jan;35(1):96-105. doi: 10.1097/01.CCM.0000250391.89780.64.

  PMID: 17095948 RESULT

• Dres M, Teboul JL, Anguel N, Guerin L, Richard C, Monnet X. Extravascular lung water, B-type natriuretic peptide, and blood volume contraction enable diagnosis of weaning-induced pulmonary edema. Crit Care Med. 2014 Aug;42(8):1882-9. doi: 10.1097/CCM.0000000000000295.

  PMID: 24717458 RESULT

• Perren A, Domenighetti G, Mauri S, Genini F, Vizzardi N. Protocol-directed weaning from mechanical ventilation: clinical outcome in patients randomized for a 30-min or 120-min trial with pressure support ventilation. Intensive Care Med. 2002 Aug;28(8):1058-63. doi: 10.1007/s00134-002-1353-z. Epub 2002 Jul 13.

  PMID: 12185425 RESULT

• 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.

  PMID: 17470624 RESULT

• Cabello B, Thille AW, Roche-Campo F, Brochard L, Gomez FJ, Mancebo J. Physiological comparison of three spontaneous breathing trials in difficult-to-wean patients. Intensive Care Med. 2010 Jul;36(7):1171-9. doi: 10.1007/s00134-010-1870-0. Epub 2010 Mar 30.

  PMID: 20352189 RESULT

• Dres M, Teboul JL, Anguel N, Guerin L, Richard C, Monnet X. Passive leg raising performed before a spontaneous breathing trial predicts weaning-induced cardiac dysfunction. Intensive Care Med. 2015 Mar;41(3):487-94. doi: 10.1007/s00134-015-3653-0. Epub 2015 Jan 24.

  PMID: 25617264 RESULT

• Caille V, Amiel JB, Charron C, Belliard G, Vieillard-Baron A, Vignon P. Echocardiography: a help in the weaning process. Crit Care. 2010;14(3):R120. doi: 10.1186/cc9076. Epub 2010 Jun 22.

  PMID: 20569504 RESULT

• Shi R, Ayed S, Beuzelin M, Persichini R, Legouge M, Vita NDE, Levy B, Beurton A, Mangal K, Hullin T, Labbe V, Guillot M, Harrois A, Cecconi M, Anguel N, Osman D, Moretto F, Lai C, Pham T, Teboul JL, Monnet X. Incidence and risk factors of weaning-induced pulmonary oedema: results from a multicentre, observational study. Crit Care. 2025 Mar 31;29(1):140. doi: 10.1186/s13054-025-05350-6.

  PMID: 40165223 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 31, 2022
• First Posted: April 8, 2022
• Study Start: July 1, 2019
• Primary Completion: February 28, 2021
• Study Completion: June 3, 2022
• Last Updated: November 16, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)