Global Physiotherapy in ICU Patients With High Risk Extubation Failure (KINEXTUB)

University Hospital of Bordeaux

Status: Enrolling

Conditions: Acute Respiratory Failure

Treatments: Procedure: Control; Procedure: Experimental

Study type: Interventional

Funder types: Other

Identifiers

NCT05423301

CHUBX 2020/51

Details and patient eligibility

About

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.

Full 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.

Enrollment: 256 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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256 participants in 2 patient groups

experimental

Experimental group

Treatment:

Procedure: Experimental

control

Active Comparator group

Treatment:

Procedure: Control