The Value of Repeated BIOMarker Measurements During an SBT to Predict EXtubation Failure in Mechanically Ventilated ICU Patients
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.
Study Type
OBSERVATIONAL
Enrollment
266
Erasmus MC
Rotterdam, South Holland, Netherlands
Extubation failure
The number of patients who were re-intubated within the next 7 days after extubation
Time frame: 7 days
All-cause mortality
The number of patients who died within 7 days after extubation
Time frame: 7-days
Rescue non-invasive ventilation or high-flow nasal oxygen for post-extubation respiratory insufficiency
The number of patients with rescue non-invasive ventilation or high-flow nasal oxygen for post-extubation respiratory insufficiency
Time frame: 7 days
Extubation failure within 48 hours and 72 hours
The number of patients who re-intubated 48- and 72 hours after extubation
Time frame: 48 hours and 72 hours
ICU length of stay post-extubation for medical reasons
The length of stay that patients were admitted in the ICU after extubation
Time frame: Up to 1 year
ICU re-admission rate within current hospitalization
The number of patients who were readmitted in the ICU within the current hospitalization
Time frame: Up to 1 year
All-cause mortality: ICU, hospital, 28-days, 3 and 12 months
The number of patients that died in the ICU, hospital, at 28-days, 3- and 12-months
Time frame: 28-days, 3 and 12 months
Major adverse cardiac event
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The number of patients that had a major adverse cardiovascular events (total death, myocardial infarction, coronary revascularization, stroke, and hospitalization because of heart failure or arrhythmia)
Time frame: 3 and 12 months
Quality of life of patients after ICU and hospital admission
The quality of life will be measured using the RAND-36 (Units on a scale)
Time frame: 3 and 12 months
Quality of life of patients after ICU and hospital admission
The quality of life will be measured using the EQ-5D questionnaire (Units on a scale)
Time frame: 3 and 12 months