Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-24 @ 11:40 PM
NCT ID:
NCT05114551
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:
NCT05114551
Study Brief:
Protocol Section:
NCT05114551