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

Henrik Endeman

Status: Active, not recruiting

Conditions: Weaning Failure; Spontaneous Breathing Trial; Mechanical Ventilation; Extubation Failure

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05637099

NL77372.078.21

Details and patient eligibility

About

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

Full 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.

Enrollment: 266 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged ≥18 years
• Mechanically ventilated for more than 48 hours
• Fulfilling readiness-to wean criteria
• Written informed consent from the patient or his/her legal representative

Exclusion criteria

• Patients with risk factors for laryngeal oedema and a negative cuff leak test (indicating upper airway obstruction with need for steroid treatment)
• Planned replacement of the endotracheal tube for a tracheostomy
• Terminal illness