Clinical trial NCT05423301: Global Physiotherapy in ICU Patients With High Risk Extubation Failure
Official title: Impact of Global Physiotherapy on Acute Respiratory Failure Within 7 Days After Extubation in Intensive Care Unit Patients With High Risk of Extubation Failure.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Respiratory Failure
Keywords: Physiotherapy
Intensive care unit
Extubation
High-risk patients
Acute respiratory failure
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2022-06-21
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Rate of acute respiratory failure
timeFrame: During 7 days post extubation
Secondary outcomes:
measure: ROX index
timeFrame: 8 hours during 7 days post extubation
measure: Rate of reintubation
timeFrame: During 7 days post extubation
measure: Rate of pneumopathy
timeFrame: During 7 days post extubation
measure: Time for respiratory care
timeFrame: During 7 days post extubation
Other outcomes:
Locations:
city: Pessac
country: France
facility: CHU de Bordeaux - Hopital Haut-Lévêque
Study officials:
References: