NCT05637099

The Value of Repeated BIOMarker Measurements During an SBT to Predict EXtubation Failure in ICU Patients

The Value of Repeated Biomarker Measurements During an SBT to Predict Extubation Failure in Mechanically Ventilated ICU Patients

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 266 (estimated)
• Sponsor: Henrik Endeman · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The Value of Repeated BIOMarker Measurements During an SBT to Predict EXtubation Failure in Mechanically Ventilated ICU Patients

Detailed description

Rationale: In order to prevent extubation failure or unnecessary prolonged ventilation, accurately predicting readiness for extubation is of key importance in ICU care. Currently, clinical criteria and spontaneous breathing trials (SBTs) are used to assess readiness for extubation. Data on the prognostic value of biomarkers in this setting are limited. Objective: To investigate the association of biomarker measurements (NT-proBNP, hsTroponin-T, CKMB, myoglobin, GDF-15, CRP, IL-6, PCT, Cystatin-C, CA-125, galectin-3, ST-2, albumin) during an SBT with extubation failure in mechanically ventilated ICU patients. Study design: Multi-centre prospective observational cohort study. Study population: Adult ICU patients who are mechanically ventilated for more than 48 hours and fulfil readiness-to wean criteria. Main study parameters/endpoints: Extubation failure (the need for reintubation within 7-days). Nature and extent of the burden and risks associated with participation, benefit and group relatedness: This study will collect data that is clinically available, but also encompasses repeated biomarker measurements, cardiopulmonary echographic examination and electrocardiography. Because almost all mechanically ventilated ICU patients have an arterial line, blood can be easily sampled without venepuncture and poses negligible risks for the study patients.

Conditions

• Weaning Failure
• Mechanical Ventilation
• Spontaneous Breathing Trial
• Extubation Failure

Timeline

• Start date: 2022-08-01
• Primary completion: 2025-05-07
• Completion: 2026-05-01
• First posted: 2022-12-05
• Last updated: 2025-12-16

Locations

1 site across 1 country: Netherlands