Global Physiotherapy in ICU Patients With High Risk Extubation Failure

Acute Respiratory Failure Clinical Trial

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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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05423301
• Other study ID #: CHUBX 2020/51
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2023
• Est. completion date: October 2025

Study information

• Verified date: April 2024
• Source: University Hospital, Bordeaux
• Contact: Anne FREYNET
• Phone: 6 63 12 01 63
• Email: anne.freynet[@]chu-bordeaux.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 256
• Est. completion date: October 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Respiratory Distress Syndrome
• Respiratory Insufficiency

Intervention

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.)
• 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.

Locations

Country	Name	City	State
France	CHU de Bordeaux - Hopital Haut-Lévêque	Pessac

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of acute respiratory failure	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.	During 7 days post extubation
Secondary	ROX index	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.	8 hours during 7 days post extubation
Secondary	Rate of reintubation	The rate of reintubation within 7 days post-extubation, with reintubation occurring contemporaneously with the onset of acute respiratory failure, without expected clinical improvement,	During 7 days post extubation
Secondary	Rate of pneumopathy	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	During 7 days post extubation
Secondary	Time for respiratory care	The mean time spent on respiratory care or mobilisation of patients estimated daily in the 7 days following extubation. Time estimated in minutes.	During 7 days post extubation