The value of repeated BIOMarker measurements during an SBT to predict EXtubation failure in mechanically ventilated ICU patients

Recruiting

• Conditions: extubation failure; Mechanical ventilation; 10019280; 10024967

• Registration Number: NL-OMON54189
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 266

Inclusion Criteria

- Aged >=18 years
- Mechanically ventilated for more than 48 hours
- Fulfilling readiness-to wean criteria (ref. no. 12 in C1 research protocol)
- Written informed consent from the patient or his/her legal representative

Exclusion Criteria

- Patients with risk factors for laryngeal edema 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
- Pregnancy

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Extubation failure within 7 days, composed of:<br /><br>- Reintubation, or<br /><br>- All-cause mortality</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Extubation failure within 48 and 72 hours<br />- Rescue non-invasive ventilation or high-flow nasal oxygen for post-extubation<br />respiratory insufficiency, or<br />- ICU length of stay post-extubation for medical reasons<br />- ICU re-admission rate within current hospitalization<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<br />(total death, myocardial infarction, coronary revascularization, stroke, and<br />hospitalization because of heart failure or arrhythmia), Quality of life<br />(RAND-36 and EQ-5D questionnaires).</p>