EXtubation With SUctioning or With Positive End-Expiratory Pressure in Intensive Care Unit (EXSUPEEP)

March 7, 2024 updated by: Centre Hospitalier de Bourg en Bresse

EXtubation With SUctioning or With Positive End-Expiratory Pressure in Intensive Care Unit: a Multicentre Randomised Controlled Trial.

Extubation in intensive care unit is a risky situation. Its failure is associated with an increase in the duration of mechanical ventilation and high morbidity and mortality.

Our hypothesis is that the extubation procedure associating prior endotracheal aspiration followed by ablation of the intubation probe under the application of a PEEP, would make it possible both to avoid the leakage of secretions towards the lower airways and the alveolar recruitment, compared to extubation with concomitant endotracheal aspiration.

By these mechanisms, this extubation procedure combining prior endotracheal aspiration followed by ablation of the tube under the application of a PEEP, would make it possible to increase the ventilator free days from any mechanical ventilation.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Extubation consists of several distinct phases: obtaining the weaning criteria, succeeding weaning test and then removing the intubation tube.

While the first two stages are the subject of numerous publications, the last one is rarely studied. To reduce the risk of failure of extubation, the scientific societies of intensive care medicine have published recommendations. They relate to patient weaning and weaning testing, but there are no clear recommendations for the procedure for removing the intubation tube.

The ablation of the tube, performed by the chest physiotherapist or nurse, typically involves endotracheal aspiration, from deflation of the cuff to removal of the intubation tube.

The objective is theoretically to prevent the secretions accumulated above the cuff, at the pharyngeal level, from falling into the lower airways.

Laboratory data show that inhalation of secretions appears to be greater during ablation of the tube with concomitant endotracheal aspiration, which creates a reverse pressure gradient, propelling the secretions into the lower airways. The application of Positive Expiratory Pressure during the ablation of the tube would help to combat this phenomenon. At the same time, this Positive Expiratory Pressure could have a beneficial effect on alveolar recruitment.

Recent work proves the non-inferiority of the ablation of the tube with the application of a Positive Expiratory Pressure versus the so-called "reference" method, consisting of endotracheal aspiration during the ablation of the tube.

We wish to conduct a comparative, prospective, randomized, multicenter study comparing extubation with concomitant endotracheal aspiration versus ablation of the intubation tube under the application of a PEEP.

Study Type

Interventional

Enrollment (Estimated)

424

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ICU Hospitalization
  • Oro-tracheal intubation
  • Mechanical ventilation for more than 24 h
  • First extubation procedure within the stay in the inclusion unit
  • Consent collected from a relative of the patient

Non-Inclusion Criteria:

  • Tracheostomy
  • Neuro-muscular pre-existant disease or severe head injury
  • Limitation of active therapeutics
  • Inclusion in an other research interfering with our outcomes
  • Non affiliated with an healthcare insurance
  • Person benefiting from enhanced protection, namely minors, pregnant or nursing women, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social establishment, adults under legal protection (safeguard of justice, guardianship or curatorship)

Exclusion Criteria:

Impossibility of extubation considered by the clinician, on:

  • Weanability criteria not met (including ineffective cough or significant bronchopulmonary congestion)
  • Unsuccessful weaning test within 72 hours of close consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PEEP Extubation With Positive End-Expiratory Pressure
endo-tracheal aspiration followed by the application of PEEP = 10 cm of H2O, maintained for 3 minutes (reventilation and rest time) and continued until the end of the procedure removal of the extubation
Procedure: Extubation with PEEP
No aspiration within the 3 minutes before extubation and extubation with 10cmH2O PEEP
Active Comparator: Aspiration Extubation With SUctioning
endo-tracheal aspiration concomitant with removal of extubation. Suction is maintained throughout the intubation tube ablation procedure
Procedure: Endotracheal Aspiration
Aspiration during cuff deflation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ventilator free days at the 28th day
Time Frame: From D day to 28th day
Number of days, totally free of any type of mechanical ventilation (invasive ou non invasive) after the extubation procedure
From D day to 28th day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Re-intubation rate
Time Frame: 3 days and 7 days
Percentage of extubation failure needing re-intubation over all patients included
3 days and 7 days
Cumulated duration of non invasive ventilation (NIV) and High flow oxygenation (HFO)
Time Frame: within 7 days
Duration marked in hours , same for NIV and HFO
within 7 days
Rate of Respiratory acute failure (RAF)
Time Frame: Within 7 days
Percentage of included patients who with clinical RAF after extubation procedure
Within 7 days
Lenght of stay in Intensive care unit (ICU) and in hospital
Time Frame: within 28 days
Marked in days.
within 28 days
Rate of death
Time Frame: Within 28 days
Whatever the cause of death for included patients
Within 28 days
Proportion of patients with pneumonia and/or atelectasis
Time Frame: within 7 days
radiological assessment of pneumonia and/or atelectasis. A systematic chest radiography is to be done at 3 days and 7 days after extubation procedure.
within 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier de Bourg en Bresse

Collaborators

Hospices Civils de Lyon
Direction Générale de l'Offre de Soins

Investigators

  • Principal Investigator: Nicholas SEDILLOT, CH Bourg en Bresse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 22, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

November 29, 2021

First Submitted That Met QC Criteria

November 29, 2021

First Posted (Actual)

December 7, 2021

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CHB20-001
  • 2022-A00334-39 (Other Identifier: ID RCB/ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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