The aim of this study is to investigate the association between biomarkers that reflect various pathophysiological mechanisms (NT-proBNP, hsTroponin-T, CKMB, myoglobin, GDF-15, CRP, IL-6, IL-10, PCT, galectin-3, ST-2, albumin) during an SBT with…
ID
Bron
Verkorte titel
Aandoening
Adult patients admitted to the ICU who are mechanically ventilated for >24h.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Extubation failure within 48 hours, composed of:
- Reintubation, or
- Rescue non-invasive ventilation or high-flow nasal oxygen for post-extubation respiratory insuf-ficiency, or
- All-cause mortality
Achtergrond van het onderzoek
Rationale: In order to prevent extubation failure or unnecessary prolonged ventilation, accurately predicting readiness for extubation is of key importance in the ICU. 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, 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 population: Adult ICU patients who are mechanically ventilated for >24h and fulfil readiness-to wean criteria.
Main study parameters/endpoints: Extubation failure (the need for reintubation within 48 hours).
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 and cardiopulmonary echographic examination. 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.
Doel van het onderzoek
The aim of this study is to investigate the association between biomarkers that reflect various pathophysiological mechanisms (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. Moreover, we will investigate the association of these biomarkers with long-term outcome after extubation. This could improve the prediction of readiness for extubation, and may direct post-ICU care in this vulnerable population.
The temporal evolution of these biomarkers during an SBT and extubation will be related to cardiopulmonary echography, in order to further elucidate the structural and functional changes in the failure-to-wean heart. Ultimately, this may direct novel treatment strategies to safely shorten duration of mechanical ventilation and to improve outcome after extubation.
Onderzoeksopzet
- 48 hours, 72 hours, 1 week, 28 days, 3 and 12 months after extubation
- ICU discharge, hospital discharge
Onderzoeksproduct en/of interventie
Not applicable.
Algemeen / deelnemers
Wetenschappers
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Aged ≥18 years
- Mechanically ventilated for >24h
- Fulfilling readiness-to wean criteria
- Written informed consent from the patient or his/her first representative
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL9286 |
| CCMO | NL77372.078.21 |
| OMON | NL-OMON54189 |