Lower or higher oxygenation targets for acute Hypoxaemic respiratory failure: Protocol for an individual patient data meta-analysis.
Acta Anaesthesiol Scand
; 67(6): 811-819, 2023 Jul.
Artículo
en Inglés
| MEDLINE | ID: covidwho-2272639
ABSTRACT
BACKGROUND:
Supplemental oxygen therapy is central to the treatment of acute hypoxaemic respiratory failure, a condition which remains a major driver for morbidity and mortality in intensive care. Despite several large randomised clinical trials comparing a higher versus a lower oxygenation target for these patients, significant differences in study design impede analysis of aggregate data and final clinical recommendations.METHODS:
This paper presents the protocol for conducting an individual patient data meta-analysis where full individual patient data according to the intention-to-treat principle will be pooled from the HOT-ICU and HOT-COVID trials in a one-step procedure. The two trials are near-identical in design. We plan to use a hierarchical general linear mixed model that accounts for data clustering at a trial and site level. The primary outcome will be 90-day all-cause mortality while the secondary outcome will be days alive without life-support at 90 days. Further, we outline 14 clinically relevant predefined subgroups which we will analyse for heterogeneity in the intervention effects and interactions, and we present a plan for assessing the credibility of the subgroup analyses.CONCLUSION:
The presented individual patient data meta-analysis will synthesise individual level patient data from two of the largest randomised clinical trials on targeted oxygen therapy in intensive care. The results will provide a re-analysis of the intervention effects on the pooled intention-to-treat populations and facilitate subgroup analyses with an increased power to detect clinically important effect modifications.Palabras clave
Texto completo:
Disponible
Colección:
Bases de datos internacionales
Base de datos:
MEDLINE
Asunto principal:
Insuficiencia Respiratoria
/
COVID-19
Tipo de estudio:
Estudio experimental
/
Estudio pronóstico
/
Ensayo controlado aleatorizado
/
Revisiones
Límite:
Humanos
Idioma:
Inglés
Revista:
Acta Anaesthesiol Scand
Año:
2023
Tipo del documento:
Artículo
País de afiliación:
Aas.14220
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