NCT05423301

Global Physiotherapy in ICU Patients With High Risk Extubation Failure

Impact of Global Physiotherapy on Acute Respiratory Failure Within 7 Days After Extubation in Intensive Care Unit Patients With High Risk of Extubation Failure.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 256 (estimated)
• Sponsor: University Hospital, Bordeaux · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Respiratory Failure

Interventions

Type	Name	Description
PROCEDURE	Experimental	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.)
PROCEDURE	Control	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.

Timeline

• Start date: 2023-10-03
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2022-06-21
• Last updated: 2026-01-21

Locations

1 site across 1 country: France