ICU Predictive Score of WEaning Success in Patients At Risk of Extubation Failure (I-SWEAR)

University Hospital, Clermont-Ferrand

Status: Enrolling

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

Study type: Observational

Funder types: Other

Identifiers

NCT05114551

I -Swear (RNI 2021 AUDARD)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

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