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

Critical Care Clinical Trial

— I-SWEAR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05114551
• Other study ID #: I -Swear (RNI 2021 AUDARD)
• Status: Recruiting
• Start date: September 28, 2021
• Est. completion date: September 28, 2023

Study information

• Verified date: January 2023
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise Laclautre
• Phone: +33 4 73 754963
• Email: promo_interne_drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: September 28, 2023
• Est. primary completion date: September 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Airway Extubation
• Area Under Curve
• Critical Care
• Echocardiography, Transthoracic
• Hypersensitivity
• Mechanical Ventilator Weaning
• Predictive Value of Tests
• Prospective Studies
• Sensitivity and Specificity
• Ultrasonography
• Ventilator Weaning

Locations

Country	Name	City	State
France	CHU	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome measure is extubation failure, defined as the need for reintubation within 72 hours of extubation.		72 hours
Secondary	Mortality at day 7, 28 and 90		90 days
Secondary	Length of stay in intensive care		90 days
Secondary	Number of days without mechanical ventilation from study inclusion to day 28		28 days
Secondary	Time frame and reasons for reintubation in case of failed extubation.		28 days
Secondary	Use of non-invasive post-extubation ventilation		7 days
Secondary	Use of High Flow Nasal Oxygenation post-extubation		7 days