Physiotherapy for ICU patients at high risk of 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.
This study is testing if physiotherapy can help older ICU patients with breathing problems do better after being taken off a ventilator compared to standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 256 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Bordeaux Academic / other |
| Locations | 1 site (Pessac) |
| Trial ID | NCT05423301 on ClinicalTrials.gov |
What this trial studies
This study compares the effectiveness of physiotherapy, which includes respiratory care and early rehabilitation, against standard care for patients in the intensive care unit who are at high risk of extubation failure. The focus is on patients who have specific risk factors such as age over 65, respiratory diseases, and prolonged intubation. The primary goal is to assess the rate of acute respiratory failure within 7 days after extubation. Secondary objectives include evaluating reintubation rates, pneumonia incidence, and the time spent on respiratory and mobilization care.
Who should consider this trial
Good fit: Ideal candidates are ICU patients over 65 years old with specific risk factors for extubation failure who are undergoing spontaneous ventilation weaning.
Not a fit: Patients who have self-extubated, have a tracheostomy, or are experiencing acute respiratory failure due to acute lung edema will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the rate of acute respiratory failure and improve recovery outcomes for high-risk ICU patients.
How similar studies have performed: While the benefits of physiotherapy in this context are poorly explored, other studies have indicated potential advantages in similar high-risk patient populations.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Pessac
- CHU de Bordeaux - Hopital Haut-Lévêque — Pessac, France (Recruiting)
Study contacts
- Study coordinator: Anne FREYNET
- Email: anne.freynet@chu-bordeaux.fr
- Phone: 6 63 12 01 63
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.