ICU Predictive Score of WEaning Success in Patients At Risk of Extubation Failure

Recruiting

• Conditions: Mechanical Ventilator Weaning; Predictive Value of Tests; Ventilator Weaning; Airway Extubation; Prospective Studies; Sensitivity and Specificity; Logistic Models; Echocardiography, Transthoracic; Biomarkers / Blood; Area Under Curve

• Registration Number: NCT05114551
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief Summary

Observational study in two medical-surgical intensive care units of the Clermont-Ferrand University Hospital to develop a composite score for prediction of 72h-extubation failure in patients at risk of extubation failure.

Detailed Description

In our intensive care units, when a patient does not have risk factors for extubation failure, SBT (Spontaneous Breathing Trial) in PSV (Pressure Support Ventilation) is usually performed first as recommended. If patient fails the first SBT in PSV or extubation, weaning is considered difficult (WIND study group AJRCCM 2017). In this case, the service protocol provides a T-piece SBT for the following SBT. In addition, this same protocol proposes to perform T-piece SBT from the first weaning event in patients with risk factors for WiPO (Weaning-induced Pulmonary Oedema), defined as obesity (BMI \>30 kg/m2), COPD (Chronic Obstructive Pulmonary Disease) (suspected or known), or heart disease (structural \[hypertrophic, dilated, valvular\], functional \[diastolic or systolic dysfunction\], ischemic, or dysrhythmic).

Our study population concerns patients for whom a T-piece trial is performed according to the service protocol.

A patient is potentially includible in the study if he has been under mechanical ventilation for at least 48h and if he presents criteria of weanability with a planned T-piece SBT. As long as the inclusion and non-inclusion criteria are respected (see inclusion/non-inclusion criteria), clinical, biological and ultrasound data will be collected before and at the end of the ventilatory weaning test. If the patient fails the weaning test and/or is not extubated following the test, data from each new T-piece SBT will be collected within 7 days of inclusion.

The global management of the patient, before, during and after the inclusion of the patient in the study is the one usually practiced in our intensive care units, based on the national and international recommendations as well as the literature exposed in the protocol.

During the patient's stay in the ICU, data from the medical record will be collected (demographic, clinical, treatment, vital status,...). A follow-up at D7, D28 and D90 will be performed.

Study Timeline

• Study Start: 2021-09-28
• Study First Submitted: 2021-10-29
• Study First Submitted QC: 2021-10-29
• Study First Posted: 2021-11-10
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-30
• Last Update Posted: 2023-01-31
• Primary Completion: 2023-09-28
• Study Completion: 2023-09-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Age > 18 years
• Invasive mechanical ventilation for at least 48 hours
• Criteria for ventilatory weaning are present
• T-piece spontaneous breathing trial planned
• Patients with a social security program

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Exclusion Criteria

• Patients already included in this study during the same stay in intensive care
• Resuscitation neuromyopathy defined by an MRC (Medical Research Council) score < 48/60
• Surgery planned within 72 hours
• Prolonged ventilatory weaning (>7 days after the first SBT)
• Patients with tracheostomy
• Patients with non-reintubation decision or terminal extubation
• Brain damaged patients
• Patients with ECMO/ECLS
• Tetraplegic or paraplegic patients with lesion level higher than T8
• Nasotracheal intubated patients
• Pregnant or breastfeeding women
• Refusal to participate in the study (refusal by patient or family member/trusted person).
• Patients under guardianship

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome measure is extubation failure, defined as the need for reintubation within 72 hours of extubation.	72 hours

Secondary Outcome Measures

Name	Time	Method
Mortality at day 7, 28 and 90	90 days
Length of stay in intensive care	90 days
Use of High Flow Nasal Oxygenation post-extubation	7 days
Time frame and reasons for reintubation in case of failed extubation.	28 days
Use of non-invasive post-extubation ventilation	7 days
Number of days without mechanical ventilation from study inclusion to day 28	28 days

Trial Locations

Locations (1)

CHU; 🇫🇷 Clermont-Ferrand, France