Global Physiotherapy in ICU Patients With High Risk Extubation Failure

Not Applicable

Recruiting

• Conditions: Acute Respiratory Failure
• Interventions: Procedure: Experimental; Procedure: Control

• Registration Number: NCT05423301
• Lead Sponsor: University Hospital, Bordeaux

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.

Detailed Description

The extubation failure rate is 15% on average in intensive care units, but can reach 30% within 48 hours after extubation in high risk patients. Their characteristics are : age \> 65 years, respiratory disease, body mass index \> 30 kg / m², intubation for more than 7 days, first extubation failure, and patient with ineffective cough associated with bronchial obstruction. The main reason for reintubation in these patients is acute respiratory failure with an ineffective cough, a bronchial obstruction, and neuromyopathy. On these three components, the physiotherapist can apply specific techniques. Even though scientific literature recommends the presence of a physiotherapist before, during and after extubation in patients intubated for more than 48 hours, the benefits of physiotherapy in this context remains poorly explored.

The main objective of this study is to compare the rate of acute respiratory failure within 7 days post-extubation in high-risk intensive care patients. The secondary objectives are to compare the ROX index, the reintubation rate for acute respiratory failure within 7 days after extubation, the rate of pneumonia at 7 days, time spent on respiratory and mobilization care.

Study Timeline

• Study First Submitted: 2022-06-14
• Study First Submitted QC: 2022-06-14
• Study First Posted: 2022-06-21
• Study Start: 2023-09-15
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-24
• Last Update Posted: 2024-04-26
• Primary Completion: 2025-09
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 256

Inclusion Criteria

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

Exclusion Criteria

• 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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental	Experimental	-
control	Control	-

Primary Outcome Measures

Name	Time	Method
Rate of acute respiratory failure	During 7 days post extubation	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.

Secondary Outcome Measures

Name	Time	Method
Rate of pneumopathy	During 7 days post extubation	Lung disease is defined by the following criteria: o Radiological signs : Two successive films from which the appearance of a focus of lung disease is suspected, If there is no history of heart or lung disease: one scan is sufficient.; o At least one of the following signs: temperature \> 38.5° without other cause leukocytes \< 4000/mm3 or \> 12000/mm3; o And at least two of the following signs: Purulent secretions Cough or dyspnoea Desaturation or increased oxygen requirement or need for ventilatory support
ROX index	8 hours during 7 days post extubation	ROX index is calculated every 8 hours during the 7 days post-extubation, ROX index is defined by the ratio of oxygen saturation measured by pulse oximetry/FiO2 to respiratory rate.
Time for respiratory care	During 7 days post extubation	The mean time spent on respiratory care or mobilisation of patients estimated daily in the 7 days following extubation. Time estimated in minutes.
Rate of reintubation	During 7 days post extubation	The rate of reintubation within 7 days post-extubation, with reintubation occurring contemporaneously with the onset of acute respiratory failure, without expected clinical improvement,

Trial Locations

Locations (1)

CHU de Bordeaux - Hopital Haut-Lévêque; 🇫🇷 Pessac, France