Herhaalde biomarker metingen rondom extubatie op de Intensive Care
- Conditions
- Adult patients admitted to the ICU who are mechanically ventilated for >24h.
- Registration Number
- NL-OMON25054
- Lead Sponsor
- Roche Diagnostics International Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 266
Inclusion Criteria
Aged =18 years
-Mechanically ventilated for >24h
-Fulfilling readiness-to wean criteria
-Written informed consent from the patient or his/her first representative
Exclusion Criteria
-Patients with risk factors for laryngeal oedema and a negative cuff leak test, performed after a successful SBT (indicating upper airway obstruction with need for steroid treatment)
-Planned replacement of the endotracheal tube for a tracheostomy
-Terminal illness
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Extubation failure within 48 hours, composed of:<br>-Reintubation, or<br>-Rescue non-invasive ventilation or high-flow nasal oxygen for post-extubation respiratory insuf-ficiency, or<br>-All-cause mortality
- Secondary Outcome Measures
Name Time Method -Extubation failure within 72h and 1 week<br>-ICU length of stay post-extubation for medical reasons<br>-ICU re-admission rate within current hospitalisation<br>-All-cause mortality: ICU, 28-days, hospital, 3 and 12 months<br>-Long-term follow-up at 3 and 12 months: major adverse cardiovascular events (total death, myocardial infarction, coronary revascularization, stroke, and hospitalization because of heart failure or arrhythmia), Quality of life (RAND-36 and EQ-5D).