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

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

Detailed Description
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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, IL-10, PCT, 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.

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

Conditions
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Weaning Failure, Mechanical Ventilation, Spontaneous Breathing Trial, Extubation Failure

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extubation failure | The number of patients who were re-intubated within the next 7 days after extubation | 7 days | 
| All-cause mortality | The number of patients who died within 7 days after extubation | 7-days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 7 days | 
| Extubation failure within 48 hours and 72 hours | The number of patients who re-intubated 48- and 72 hours after extubation | 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 | 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 | 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 | 28-days, 3 and 12 months | 
| Major adverse cardiac event | 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) | 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) | 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) | 3 and 12 months |