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Endotracheal Suctionning During Positive Pressure Extubation in ICU (INTENTION)

C

Centre Hospitalier Régional d'Orléans

Status

Not yet enrolling

Conditions

Weaning Invasive Mechanical Ventilation
Rox Index
Oxygen Saturation Measurement
Mechanical Ventilation With Oral Intubation
Extubation

Treatments

Procedure: Suctionning extubation
Procedure: No suctionning Extubation

Study type

Interventional

Funder types

Other

Identifiers

NCT07130123
CHUO-2025-12

Details and patient eligibility

About

The aim of this clinical trial is to evaluate endotracheal suctioning during positive pressure extubation in mechanically ventilated adult patients (over 18 years old) in the intensive care unit (ICU). The main question it aims to answer is whether the intervention improves the respiratory oxygenation index (ROX) three hours after extubation compared to no endotracheal suction during positive pressure extubation.

Participants will only need to be extubated by the nursing team in the ICU. Follow-up will consist of evaluating respiratory rate, pulse oximetry and inspired oxygen fraction for three hours following extubation.

Full description

This is a prospective, randomised, controlled trial. The aim of this study is to evaluate endotracheal suctioning during positive pressure extubation in mechanically ventilated adult patients (over 18 years old) in the intensive care unit (ICU). The main question it aims to answer is whether the intervention improves the respiratory oxygenation index (ROX) three hours after extubation compared to no endotracheal suction during positive pressure extubation.

Inclusion : Participants who meet eligibility criteria will be randomized into experimental arm (endotracheal suctioning during positive pressure extubation) or control arm (no endotracheal suction during positive pressure extubation).

Intervention and Follow-up : participants will only need to be extubated by the nursing team in the ICU. Follow-up will consist of evaluating respiratory rate, pulse oximetry and inspired oxygen fraction for three hours following extubation.

End of study : at the end of the study visit (28 days after extubation), vital status of participants will be recorded.

Enrollment

120 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Adult patient
  • Intubated for more than 48 hours
  • Patient for whom extubation is prescribed by the patient's physician

Exclusion criteria

  • Headboard restriction>30°.
  • Decision to limit active treatment in advance of reintubation
  • Protected person (under guardianship or curatorship)
  • Person under court protection
  • Persons deprived of liberty
  • Persons not affiliated to a social security scheme
  • Pregnant or breast-feeding woman
  • No co-inclusion with a study whose period of interest is follow-up within 3 hours of extubation.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

120 participants in 2 patient groups

Suctionning Extubation (experimental arm)
Experimental group
Description:
Endotracheal suctioning during positive pressure extubation in mechanically ventilated adult patients in the intensive care unit.
Treatment:
Procedure: Suctionning extubation
No Suctionning Extubation (control arm)
Sham Comparator group
Description:
No endotracheal suctioning during positive pressure extubation in mechanically ventilated adult patients in the intensive care unit.
Treatment:
Procedure: No suctionning Extubation

Trial contacts and locations

1

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Central trial contact

Fanny LOUAT; Cécile FOSSAT

Data sourced from clinicaltrials.gov

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