Global Physiotherapy in ICU Patients With High Risk Extubation Failure

NCT05423301 | Completed

• 1 other identifier: CHUBX 2020/51
• Study Type: interventional
• Target: 245
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare care provided by physiotherapists, combining respiratory care and early rehabilitation in intensive care unit, with standard care on the rate of acute respiratory failure within 7 days after extubation, in patients with high risk of extubation failure.

Conditions

Acute Respiratory Failure

Keywords

Physiotherapy; Intensive care unit; Extubation; High-risk patients; Acute respiratory failure

Outcome Measures

Primary Outcomes (1)

• Rate of acute respiratory failure

  The primary endpoint is the proportion of patients with post-extubation acute respiratory failure, defined as the occurrence within 7 days of extubation of at least two of the following criteria: respiratory acidosis (pH \<7.35, PaCO2 \>45 mmHg), hypoxemia (PaO2 \<60 mmHg with a FiO2 \>40% or PaO2/FiO2\<150) and respiratory rate \>35/min.

  During 7 days post extubation

Secondary Outcomes (4)

• ROX index

  8 hours during 7 days post extubation

• Rate of reintubation

  During 7 days post extubation

• Rate of pneumopathy

  During 7 days post extubation

• Time for respiratory care

  During 7 days post extubation

Study Arms (2)

experimental

EXPERIMENTAL

Procedure: Experimental

control

ACTIVE COMPARATOR

Procedure: Control

Interventions

Experimental PROCEDURE

Respiratory care consists of manual and instrumental bronchial clearance techniques: Expiratory Flow Enhancement (EFE), suctioning, manual cough assist techniques, instrumental clearance techniques (suctioning and Cough Assist) and swallowing disorder management.)

experimental

Control PROCEDURE

The control group will receive early respiratory care and rehabilitation by nurses, nurses' aides and doctors until D7. Respiratory care includes aerosol therapy, oral and pharyngeal clearance with aspirations, verbal coughing and sputum removal, and possibly bronchial fibroscopy for clearance if necessary. Early rehabilitation consists of alternating postures in bed, passive chair positioning (patient lift), or active positioning via a bed rail and standing.

control

Eligibility Criteria

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

You may qualify if:

• Patients with spontaneous ventilation weaning test.
• Consent form signed by the person support.

You may not qualify if:

• Patients with a self-extubation,
• Patients with a tracheostomy,
• Patients with acute respiratory failure for acute lung edema (OAP),
• Patients with decision to limit or stop Active Therapeutics (LATA).

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU de Bordeaux - Hopital Haut-Lévêque

Pessac, 33604, France

Location

Study Design

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

Model Details: The proposed study will be a single-center open-label comparative randomized clinical study, in two parallel arms, at the Bordeaux University Hospital. Patients extubated during working hours on Mondays to Friday in the presence of the physiotherapy team will be included in the study and randomized with a 1: 1 ratio between the experimental arm and the control arm. In both groups, patients are routinely alternated between high-flow oxygenation and NIV, adjusted to patient-specific goals, as recommended for these patients.

Study Record Dates

• First Submitted: June 14, 2022
• First Posted: June 21, 2022
• Study Start: October 3, 2023
• Primary Completion: May 7, 2026
• Study Completion: May 7, 2026
• Last Updated: May 14, 2026

Record last verified: 2026-05

Locations

FR (1)