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

NCT ID: NCT05147636

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 425 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-22
• Study Completion Date: 2025-03-19

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.

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.

Conditions

Extubation in Intensive Care Unit

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Extubation with PEEP

Intervention Type: PROCEDURE

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

Aspiration Extubation With SUctioning

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

Group Type: ACTIVE_COMPARATOR

Endotracheal Aspiration

Intervention Type: PROCEDURE

Aspiration during cuff deflation

Interventions

Extubation with PEEP

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

Intervention Type: PROCEDURE

Endotracheal Aspiration

Aspiration during cuff deflation

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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)
• Inclusion in another research project that interferes with the outcomes of the present study
• 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

Patients with personal NIV or continuous positive airway pressure at home will be included if Pressure Support (PS) and/or PEEP used in the ICU unit are different from the usual settings at home. Regarding infection by SARS-CoV-2 or use of endotracheal tubes with subglottic suction, they do not constitute an exclusion criterion.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Direction Générale de l'Offre de Soins

OTHER_GOV

Sponsor Role: collaborator

Hospices Civils de Lyon

OTHER

Sponsor Role: collaborator

the EXSUPEEP study was supported by a grant from the French Ministry of Health (MoH-fr)

UNKNOWN

Sponsor Role: collaborator

Centre Hospitalier de Bourg en Bresse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicholas SEDILLOT

Role: PRINCIPAL_INVESTIGATOR

CH Bourg en Bresse

Locations

CHU Orléans

Orléans, Orléans, France

CH Annecy Genevois

Annecy, , France

CH Victor Dupouy

Argenteuil, , France

CH Bourg en Bresse

Bourg-en-Bresse, , France

CHU Francois Mitterand

Dijon, , France

CHU Michallon

Grenoble, , France

HCL Croix Rousse

Lyon, , France

HCL Edouard Herriot

Lyon, , France

HCL Lyon Sud

Lyon, , France

CHU La Miletrie

Poitiers, , France

Hopital Nord

Saint-Etienne, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 39947817 (View on PubMed)

Other Identifiers

2022-A00334-39

Identifier Type: OTHER

Identifier Source: secondary_id

CHB20-001

Identifier Type: -

Identifier Source: org_study_id