Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2025 Feb 13;15(2):e092354.
doi: 10.1136/bmjopen-2024-092354.

Applying positive end-expiratory pressure before and during endotracheal tube removal versus extubation with concomitant aspiration: protocol for the randomised controlled multicentre EXSUPEEP trial

Nicholas Sedillot  1 , Hela Kallel  2 , Adrien Robine  2 , Jose Arturo Pineda  3   4 , Jean-Pierre Quenot  3   4 , Marion Servant  5 , Albrice Levrat  5 , Clovis Damieux-Verdeau  6 , Mehdi Mezidi  6 , Nathalie Thibert  7 , Julien Bohé  7 , Alvaro Ballesteros-Calzado  8 , Neven Stevic  8 , Lena Mahi  9 , Florian Sigaud  9 , Margaux Maisonneuve  10 , Guillaume Thiery  10 , Paul Prat  11 , Arnaud W Thille  11 , Safia Haouat  12 , Gaetan Plantefeve  12 , Evelyne Decullier  13 , Muriel Rabilloud  13 , Pauline Bernon  2 , Yves Poncelin  2 , Julie Catherine Bonnici  2
Affiliations

Applying positive end-expiratory pressure before and during endotracheal tube removal versus extubation with concomitant aspiration: protocol for the randomised controlled multicentre EXSUPEEP trial

Nicholas Sedillot et al. BMJ Open. .

Abstract

Introduction: The optimal method for removing the endotracheal tube (ETT) during extubation in the intensive care unit (ICU) remains uncertain. Two methods are described for removing the ETT in ICU, namely the 'Traditional technique' with continuous aspiration during cuff deflation and ETT removal; and the 'PEEP' method, which consists in applying positive end-expiratory pressure (PEEP) before and during cuff deflation and ETT removal. Our hypothesis is that applying PEEP during extubation in the ICU would improve clinical outcome.

Methods and analysis: This is a prospective, multicentre, randomised, open-label, controlled, superiority trial, analysed by intention-to-treat, comparing ETT removal with concomitant suction vs application of PEEP before and during ETT removal. In total, 424 patients will be recruited and randomly assigned in a 1:1 ratio to one of two groups, according to the strategy of ETT removal. The primary outcome is the number of days free from any mechanical ventilation within 28 days following extubation. Secondary outcomes include the reintubation rate up to 7 days after ETT removal, the cumulative duration of non-invasive ventilation up to 7 days following extubation, the rate of acute respiratory failure, the rate of acquired pneumonia during the first 7 days following ETT removal, the length of stay in ICU and in hospital and all-cause mortality at 28 days following ETT removal.

Ethics and dissemination: The study was approved by the Ethics Committee 'CPP Ile de France II'. Patients will be included after providing written informed consent. The results will be submitted for publication in peer-reviewed journals, and in national and international congresses.

Trial registration number: NCT05147636.

Keywords: Adult intensive & critical care; Clinical Trial; Respiratory Therapy.

PubMed Disclaimer

Conflict of interest statement

Competing interests: The EXSUPEEP team and all investigators do not have any conflicts of interest to declare in connection with the study.

Figures

Figure 1
Figure 1. Flow chart of the patients and study design. ETT, endotracheal tube; HFO, high flow oxygen; ICU, intensive care unit; NIV, non-invasive ventilation; PEEP, positive end-expiratory pressure.
Figure 2
Figure 2. Flow chart of study showing variables collected at each timepoint. HFO, high flow oxygen; ICU, intensive care unit.
See this image and copyright information in PMC

References

    1. Esteban A, Anzueto A, Frutos F, et al. Characteristics and outcomes in adult patients receiving mechanical ventilation: a 28-day international study. JAMA. 2002;287:345–55. doi: 10.1001/jama.287.3.345. - DOI - PubMed
    1. Thille AW, Richard JCM, Brochard L. The decision to extubate in the intensive care unit. Am J Respir Crit Care Med. 2013;187:1294–302. doi: 10.1164/rccm.201208-1523CI. - DOI - PubMed
    1. Thille AW, Gacouin A, Coudroy R, et al. Spontaneous-Breathing Trials with Pressure-Support Ventilation or a T-Piece. N Engl J Med. 2022;387:1843–54. doi: 10.1056/NEJMoa2209041. - DOI - PubMed
    1. Esteban A, Alía I, Gordo F, et al. Extubation outcome after spontaneous breathing trials with T-tube or pressure support ventilation. The Spanish Lung Failure Collaborative Group. Am J Respir Crit Care Med. 1997;156:459–65. doi: 10.1164/ajrccm.156.2.9610109. - DOI - PubMed
    1. Pham T, Heunks L, Bellani G, et al. Weaning from mechanical ventilation in intensive care units across 50 countries (WEAN SAFE): a multicentre, prospective, observational cohort study. Lancet Respir Med. 2023;11:465–76. doi: 10.1016/S2213-2600(22)00449-0. - DOI - PubMed

Publication types

MeSH terms

Associated data

LinkOut - more resources