Endotracheal Suctionning During Positive Pressure Extubation in ICU

NCT07130123 | Recruiting

• 1 other identifier: CHUO-2025-12
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

rox index; extubation; Suctionning

Outcome Measures

Primary Outcomes (1)

• Respiratoy/oxygenation index (ROX index)

  Rox index will be assessed 3 hours after extubation by an investigator with no information about randomization (blind assessment)

  3 hours after extubation

Secondary Outcomes (4)

• Mechanical ventilation weaning failure

  During 7 days after extubation

• ROX index evolution

  During 3 hours after extubation

• Pneumonia after extubation

  During 7 days after extubation

• Airway clearance technique

  During 24 hours after extubation

Study Arms (2)

Suctionning Extubation (experimental arm)

EXPERIMENTAL

Endotracheal suctioning during positive pressure extubation in mechanically ventilated adult patients in the intensive care unit.

Procedure: Suctionning extubation

No Suctionning Extubation (control arm)

SHAM COMPARATOR

No endotracheal suctioning during positive pressure extubation in mechanically ventilated adult patients in the intensive care unit.

Procedure: No suctionning Extubation

Interventions

Suctionning extubation PROCEDURE

We will remove the intubation tube with endotracheal suctioning during the extubation procedure and maintain positive end expiratory pressure (PEEP) and pressure support. The PEEP level will be 10 cmH2O and the pressure support 7 cmH2O for 2 minutes prior to extubation. The vacuum level will be the maximum level (standard procedure in the unit), i.e. 450 mmHg. The closed-system suction probe is inserted up to the last mark corresponding to 40cm. The size of our closed system is identical for all patients, i.e. 14 french.

Suctionning Extubation (experimental arm)

No suctionning Extubation PROCEDURE

In the control group, removal of the intubation tube during the extubation procedure is performed with PEEP maintained, without endotracheal suctioning. The PEEP level will be set at 10 cmH2O and the pressure at 7 cmH2O in the 2 minutes prior to extubation.

No Suctionning Extubation (control arm)

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Régional d'Orléans: lead

Study Sites (1)

Centre Hospitalier Universitaire d'Orléans

Orléans, Loiret, 45067, France

RECRUITING

Related Publications (5)

• Chastre J, Fagon JY. Ventilator-associated pneumonia. Am J Respir Crit Care Med. 2002 Apr 1;165(7):867-903. doi: 10.1164/ajrccm.165.7.2105078.

  PMID: 11934711 BACKGROUND

• Levine S, Nguyen T, Taylor N, Friscia ME, Budak MT, Rothenberg P, Zhu J, Sachdeva R, Sonnad S, Kaiser LR, Rubinstein NA, Powers SK, Shrager JB. Rapid disuse atrophy of diaphragm fibers in mechanically ventilated humans. N Engl J Med. 2008 Mar 27;358(13):1327-35. doi: 10.1056/NEJMoa070447.

  PMID: 18367735 BACKGROUND

• 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 BACKGROUND

• Frutos-Vivar F, Esteban A, Apezteguia C, Gonzalez M, Arabi Y, Restrepo MI, Gordo F, Santos C, Alhashemi JA, Perez F, Penuelas O, Anzueto A. Outcome of reintubated patients after scheduled extubation. J Crit Care. 2011 Oct;26(5):502-509. doi: 10.1016/j.jcrc.2010.12.015. Epub 2011 Mar 3.

  PMID: 21376523 BACKGROUND

• Fossat G, Desmalles E, Courtes L, Fossat C, Boulain T. Cough Peak Flow Assessment Without Disconnection From the ICU Ventilator in Mechanically Ventilated Patients. Respir Care. 2023 Apr;68(4):470-477. doi: 10.4187/respcare.10412. Epub 2023 Mar 6.

  PMID: 36878644 BACKGROUND

Study Officials

• Cécile FOSSAT

  Centre Hospitalier Universitaire d'Orléans

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cécile FOSSAT

CONTACT

+33238575252; fanny.louat@chu-orleans.fr

Fanny LOUAT

CONTACT

+33238744295; fanny.louat@chu-orleans.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: August 19, 2025
• Study Start: October 3, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

FR (1)