Clinical trial NCT05637099: The Value of Repeated BIOMarker Measurements During an SBT to Predict EXtubation Failure in ICU Patients
Official title: The Value of Repeated Biomarker Measurements During an SBT to Predict Extubation Failure in Mechanically Ventilated ICU Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Weaning Failure
Mechanical Ventilation
Spontaneous Breathing Trial
Extubation Failure
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Roche Diagnostics GmbH
First posted: 2022-12-05
Enrollment: 266
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients admitted to the ICUs of the Erasmus MC, the Franciscus Gasthuis \& Vlietland, Groene Hart ziekenhuis, Amphia ziekenhuis, and OLVG, who are mechanically ventilated for more than 48 hours.

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Extubation failure
timeFrame: 7 days
measure: All-cause mortality
timeFrame: 7-days
Secondary outcomes:
measure: Rescue non-invasive ventilation or high-flow nasal oxygen for post-extubation respiratory insufficiency
timeFrame: 7 days
measure: Extubation failure within 48 hours and 72 hours
timeFrame: 48 hours and 72 hours
measure: ICU length of stay post-extubation for medical reasons
timeFrame: Up to 1 year
measure: ICU re-admission rate within current hospitalization
timeFrame: Up to 1 year
measure: All-cause mortality: ICU, hospital, 28-days, 3 and 12 months
timeFrame: 28-days, 3 and 12 months
measure: Major adverse cardiac event
timeFrame: 3 and 12 months
measure: Quality of life of patients after ICU and hospital admission
timeFrame: 3 and 12 months
measure: Quality of life of patients after ICU and hospital admission
timeFrame: 3 and 12 months
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus MC
state: Zuid-Holland
Study officials:
affiliation: Erasmus Medical Center
name: H. Endeman, Dr.
role: PRINCIPAL_INVESTIGATOR
References: