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

NCT05637099 | Active Not Recruiting DMC

• 1 other identifier: NL77372.078.21
• Study Type: observational
• Target: 266
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Weaning Failure; Mechanical Ventilation; Spontaneous Breathing Trial; Extubation Failure

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Rescue non-invasive ventilation or high-flow nasal oxygen for post-extubation respiratory insufficiency

  7 days

• Extubation failure within 48 hours and 72 hours

  48 hours and 72 hours

• ICU length of stay post-extubation for medical reasons

  Up to 1 year

• ICU re-admission rate within current hospitalization

  Up to 1 year

• All-cause mortality: ICU, hospital, 28-days, 3 and 12 months

  28-days, 3 and 12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Henrik Endeman: lead
• Roche Diagnostics GmbH: collaborator

Study Sites (1)

Erasmus MC

Rotterdam, South Holland, 3015 GD, Netherlands

Location

Study Officials

• H. Endeman, Dr.

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 7, 2022
• First Posted: December 5, 2022
• Study Start: August 1, 2022
• Primary Completion: May 7, 2025
• Study Completion: May 1, 2026
• Last Updated: December 16, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)