Extubation Failure, Mechanical Ventilation, Spontaneous Breathing Trial, Weaning Failure
Conditions
Brief summary
The Value of Repeated BIOMarker Measurements During an SBT to Predict EXtubation Failure in Mechanically Ventilated ICU Patients
Detailed description
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, PCT, Cystatin-C, CA-125, 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.
Interventions
None listed
Sponsors
Henrik Endeman
Roche Diagnostics GmbH
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Extubation failure | 7 days | The number of patients who were re-intubated within the next 7 days after extubation |
| All-cause mortality | 7-days | The number of patients who died within 7 days after extubation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rescue non-invasive ventilation or high-flow nasal oxygen for post-extubation respiratory insufficiency | 7 days | The number of patients with rescue non-invasive ventilation or high-flow nasal oxygen for post-extubation respiratory insufficiency |
| Extubation failure within 48 hours and 72 hours | 48 hours and 72 hours | The number of patients who re-intubated 48- and 72 hours after extubation |
| ICU length of stay post-extubation for medical reasons | Up to 1 year | The length of stay that patients were admitted in the ICU after extubation |
| ICU re-admission rate within current hospitalization | Up to 1 year | The number of patients who were readmitted in the ICU within the current hospitalization |
| All-cause mortality: ICU, hospital, 28-days, 3 and 12 months | 28-days, 3 and 12 months | The number of patients that died in the ICU, hospital, at 28-days, 3- and 12-months |
| Major adverse cardiac event | 3 and 12 months | 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) |
| Quality of life of patients after ICU and hospital admission | 3 and 12 months | The quality of life will be measured using the RAND-36 (Units on a scale) |
Countries
Netherlands
Contacts
PRINCIPAL_INVESTIGATORH. Endeman, Dr.
Erasmus Medical Center
Outcome results
None listed