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.
ID
Source
Brief title
Condition
- Heart failures
- Lower respiratory tract disorders (excl obstruction and infection)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Extubation failure within 7 days, composed of:
- Reintubation, or
- All-cause mortality
Secondary outcome
- Extubation failure within 48 and 72 hours
- Rescue non-invasive ventilation or high-flow nasal oxygen for post-extubation
respiratory insufficiency, or
- ICU length of stay post-extubation for medical reasons
- ICU re-admission rate within current hospitalization
- All-cause mortality: ICU, 28-days, hospital, 3 and 12 months
- 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 questionnaires).
Background summary
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.
A more detailed description of the study background is provided on page 8 of
the C1 research protocol.
Study 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 burden and risks
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.
Hoevestraat 25B
Rotterdam 3033 GB
NL
Hoevestraat 25B
Rotterdam 3033 GB
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT05637099 |
| CCMO | NL77372.078.21 |