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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05114551
Acronym
I-SWEAR
Enrollment
300
Registered
2021-11-10
Start date
2021-09-28
Completion date
2023-09-28
Last updated
2023-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

None listed

Sponsors

University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
The primary outcome measure is extubation failure, defined as the need for reintubation within 72 hours of extubation.72 hours

Secondary

MeasureTime frame
Length of stay in intensive care90 days
Number of days without mechanical ventilation from study inclusion to day 2828 days
Mortality at day 7, 28 and 9090 days
Use of non-invasive post-extubation ventilation7 days
Use of High Flow Nasal Oxygenation post-extubation7 days
Time frame and reasons for reintubation in case of failed extubation.28 days

Countries

France

Contacts

Primary ContactLise Laclautre
promo_interne_drci@chu-clermontferrand.fr+33 4 73 754963
Backup ContactJules Audard
jaudard@chu-clermontferrand.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026