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

NCT05114551 | Unknown

• 1 other identifier: I -Swear (RNI 2021 AUDARD)
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

  72 hours

Secondary Outcomes (6)

• Mortality at day 7, 28 and 90

  90 days

• Length of stay in intensive care

  90 days

• Number of days without mechanical ventilation from study inclusion to day 28

  28 days

• Time frame and reasons for reintubation in case of failed extubation.

  28 days

• Use of non-invasive post-extubation ventilation

  7 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patients included in this study will be all the patients hospitalized in our 2 intensive care units, under mechanical ventilation for at least 48h, meeting the criteria of weanability and for whom a T-piece SBT will be planned.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU

Clermont-Ferrand, 63000, France

RECRUITING

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Central Study Contacts

Lise Laclautre

CONTACT

+33 4 73 754963; promo_interne_drci@chu-clermontferrand.fr

Jules Audard

CONTACT

jaudard@chu-clermontferrand.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2021
• First Posted: November 10, 2021
• Study Start: September 28, 2021
• Primary Completion: September 28, 2023
• Study Completion: September 28, 2023
• Last Updated: January 31, 2023

Record last verified: 2023-01

Locations

FR (1)