Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07130123

Removal of the Intubation Tube Under Positive Pressure With or Without Endotracheal Suctioning During Extubation in Intensive Care: a Prospective Randomised Controlled Trial

Led by Centre Hospitalier Régional d'Orléans · Updated on 2025-12-19

120

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating endotracheal suctioning during positive pressure extubation in adults who are mechanically ventilated in the intensive care unit (ICU). This study aims to determine if using suction during extubation improves the respiratory oxygenation index (ROX) measured three hours later compared to extubation without suction. The study is prospective, randomized, and controlled, focusing on patients intubated for more than 48 hours and ready for extubation as prescribed by their physician. Participants will be randomly assigned to one of two groups: one group will have the intubation tube removed using endotracheal suctioning while maintaining positive end expiratory pressure (PEEP) and pressure support, with specific settings for vacuum and pressure; the other group will have the tube removed without suctioning but with the same PEEP and pressure support settings. The suctioning device used is a closed-system probe with a standard size. Extubation will be performed by the nursing team in the ICU. After extubation, participants will be monitored for three hours with assessments including respiratory rate, pulse oximetry, and inspired oxygen fraction to evaluate respiratory function. The primary outcome is the ROX index measured three hours after extubation. Secondary outcomes include mechanical ventilation weaning failure and pneumonia occurrence within seven days, as well as airway clearance within 24 hours. Vital status will be recorded 28 days after extubation to complete the study follow-up.

CONDITIONS

Brief Title

Endotracheal Suctionning During Positive Pressure Extubation in ICU

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patient
  • Intubated for more than 48 hours
  • Patient scheduled for extubation as prescribed by their physician
Not Eligible

You will not qualify if you...

  • Headboard restriction greater than 30 degrees
  • Decision to limit active treatment before reintubation
  • Under guardianship, curatorship, or court protection
  • Persons deprived of liberty
  • Not affiliated with a social security scheme
  • Pregnant or breastfeeding women
  • Participation in another study involving follow-up within 3 hours of extubation

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Single procedure on the day of extubation

Participants undergo extubation in the intensive care unit with or without endotracheal suctioning during positive pressure extubation as per their assigned group.

1 extubation procedure visit (in ICU)

Follow-up

Duration - 28 days post-extubation

Participants are monitored for respiratory rate, pulse oximetry, inspired oxygen fraction for three hours after extubation, and their vital status is recorded 28 days after extubation.

Continuous monitoring for 3 hours post-extubation and 1 study completion visit at 28 days

Trial Site Locations

Total: 1 location

1

Centre Hospitalier Universitaire d'Orléans

Orléans, Loiret, France, 45067

Actively Recruiting

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Research Team

C

Cécile FOSSAT

F

Fanny LOUAT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Cough Peak Flow Assessment Without Disconnection From the ICU Ventilator in Mechanically Ventilated Patients.

Guillaume Fossat, Emmanuelle Desmalles, Léa Courtes...

https://pubmed.ncbi.nlm.nih.gov/36878644