KINEXTUB: Global Physiotherapy in ICU Patients With High Risk Extubation Failure
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: experimental
|
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.)
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| Active Comparator: control
|
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.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
- 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,
- 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
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients with spontaneous ventilation weaning test.
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Consent form signed by the person support.
Exclusion Criteria:
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Patients with a self-extubation,
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Patients with a tracheostomy,
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Patients with acute respiratory failure for acute lung edema (OAP),
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Patients with decision to limit or stop Active Therapeutics (LATA).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU de Bordeaux - Hopital Haut-Lévêque | Pessac | France | 33604 |
Sponsors and Collaborators
- University Hospital, Bordeaux
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CHUBX 2020/51