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

NCT05147636 | Completed DMC

• 2 other identifiers: CHB20-0012022-A00334-39
• Study Type: interventional
• Target: 425
• Locations: 1 country
• Sites: 11

Brief Summary

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.

Conditions

Extubation in Intensive Care Unit

Keywords

extubation; intensive care; endotracheal aspiration; positive end expiratory pressure; non invasive ventilation

Outcome Measures

Primary Outcomes (1)

• Ventilator free days at the 28th day

  The primary endpoint is the number of mechanical ventilation-free days (invasive and non-invasive) after the first extubation procedure

  From DZéro to D27

Secondary Outcomes (6)

• Re-intubation rate

  7 days (from Dzéro to D6)

• Cumulated duration of non invasive ventilation (NIV) and High flow oxygenation (HFO)

  7 days (from Dzéro to D6)

• Proportion of patients with pneumonia and/or atelectasis

  within 72 hours ( D2) and within 7 days ( D6)

• Rate of Respiratory acute failure (RAF)

  Within 7 days (from Dzéro to D6)

• Lenght of stay in Intensive care unit (ICU) and in hospital

  within 28 days

Study Arms (2)

PEEP Extubation With Positive End-Expiratory Pressure

EXPERIMENTAL

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

Aspiration Extubation With SUctioning

ACTIVE COMPARATOR

endo-tracheal aspiration concomitant with removal of extubation. Suction is maintained throughout the intubation tube ablation procedure

Procedure: Endotracheal Aspiration

Interventions

Extubation with PEEP PROCEDURE

No aspiration within the 3 minutes before extubation and extubation with 10cmH2O PEEP

PEEP Extubation With Positive End-Expiratory Pressure

Endotracheal Aspiration PROCEDURE

Aspiration during cuff deflation

Aspiration Extubation With SUctioning

Eligibility Criteria

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

You may qualify if:

• Firstly, the decision to extubate must be made by the treating clinicians after having validated that the clinical criteria for weaning are met, namely: according to the international conference consensus on weaning , patients will be considered as ready for an initial SBT as soon as they meet all of the following criteria:
• respiratory rate ≤35 breaths per minute,
• adequate oxygenation defined as pulse oximetry (SpO2 ≥90%) with a fraction of inspired oxygen (FiO2) ≤0.4 or PaO2/FiO2 ≥150 mmHg with positive end-expiratory pressure ≤8 cm H2O,
• hemodynamic stability with no need for vasopressors (or doses ≤0.3 μg/kg/min),
• adequate cough,
• patient awake with a Richmond Agitation-Sedation Scale between +1 and -2
• Patients meeting any of the following criteria will be included in the EXSUPEEP trial:
• ICU Hospitalization
• Oro-tracheal intubation
• Mechanical ventilation for more than 24 h
• First extubation procedure during the stay in the including unit
• Consent collected from a relative of the patient. Once it has been verified that the patient meets all the eligibility criteria listed above, the patient may be extubated after a successful SBT and after obtaining consent from the patient or family.

You may not qualify if:

• Patients meeting any of the following criteria will be excluded from the EXSUPEEP trial:
• Patients receiving ventilation via tracheostomy.
• Patients with underlying chronic neuromuscular disease
• Patients with severe head injury
• Patients with a decision to withhold and/or withdraw life support
• Patients not affiliated to or beneficiary of any social security scheme.
• Person benefiting from enhanced protection, namely minors, pregnant or nursing women, persons deprived of their liberty by a judicial or administrative decision, persons residing in a healthcare or social establishment, adults under legal protection (safeguard of justice, guardianship or curatorship)
• Weanability criteria not met within 72 hours following the signing of consent by the relatives.
• Unsuccessful weaning test within 72 hours following the signing of consent by the relatives

Sponsors & Collaborators

• Centre Hospitalier de Bourg en Bresse: lead
• Direction Générale de l'Offre de Soins: collaborator
• Hospices Civils de Lyon: collaborator
• the EXSUPEEP study was supported by a grant from the French Ministry of Health (MoH-fr): collaborator

Study Sites (11)

CHU Orléans

Orléans, Orléans, France

Location

CH Annecy Genevois

Annecy, France

Location

CH Victor Dupouy

Argenteuil, France

Location

CH Bourg en Bresse

Bourg-en-Bresse, France

Location

CHU Francois Mitterand

Dijon, France

Location

CHU Michallon

Grenoble, France

Location

HCL Croix Rousse

Lyon, France

Location

HCL Edouard Herriot

Lyon, France

Location

HCL Lyon Sud

Lyon, France

Location

CHU La Miletrie

Poitiers, France

Location

Hopital Nord

Saint-Etienne, France

Location

Related Publications (1)

• Sedillot N, Kallel H, Robine A, Pineda JA, Quenot JP, Servant M, Levrat A, Damieux-Verdeau C, Mezidi M, Thibert N, Bohe J, Ballesteros-Calzado A, Stevic N, Mahi L, Sigaud F, Maisonneuve M, Thiery G, Prat P, Thille AW, Haouat S, Plantefeve G, Decullier E, Rabilloud M, Bernon P, Poncelin Y, Bonnici JC. Applying positive end-expiratory pressure before and during endotracheal tube removal versus extubation with concomitant aspiration: protocol for the randomised controlled multicentre EXSUPEEP trial. BMJ Open. 2025 Feb 13;15(2):e092354. doi: 10.1136/bmjopen-2024-092354.

  PMID: 39947817 DERIVED

MeSH Terms

Interventions

Airway Extubation; Positive-Pressure Respiration

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Investigative Techniques; Respiration, Artificial; Respiratory Therapy

Study Officials

• Nicholas SEDILLOT

  CH Bourg en Bresse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: December 7, 2021
• Study Start: March 22, 2023
• Primary Completion: March 19, 2025
• Study Completion: March 19, 2025
• Last Updated: December 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (11)