期刊
PEDIATRIC CRITICAL CARE MEDICINE
卷 23, 期 9, 页码 736-744出版社
LIPPINCOTT WILLIAMS & WILKINS
DOI: 10.1097/PCC.0000000000003008
关键词
child; critical care; hyperoxia; hypoxia; mechanical ventilation; oxygen saturation
资金
- National Institute for Health Research (NIHR) Health Technology Assessment Programme [12/75/47]
- Intensive Care National Audit & Research Centre (ICNARC)
This study aims to evaluate the clinical effectiveness and cost-effectiveness of conservative and liberal oxygen saturation targets in pediatric critical care. It will be conducted in 15 PICUs across England, Wales, and Scotland, with measurements and outcomes recorded to assess the impact of the two targets.
OBJECTIVES: Oxygen administration is a fundamental part of pediatric critical care, with supplemental oxygen offered to nearly every acutely unwell child. However, optimal targets for systemic oxygenation are unknown. Oxy-PICU aims to evaluate the clinical effectiveness and cost-effectiveness of a conservative peripheral oxygen saturation (Spo(2)) target of 88-92% compared with a liberal target of more than 94%. DESIGN: Pragmatic, open, multiple-center, parallel group randomized control trial with integrated economic evaluation. SETTING: Fifteen PICUs across England, Wales, and Scotland. PATIENTS: Infants and children age more than 38 week-corrected gestational age to 16 years who are accepted to a participating PICU as an unplanned admission and receiving invasive mechanical ventilation with supplemental oxygen for abnormal gas exchange. INTERVENTION: Adjustment of ventilation and inspired oxygen settings to achieve an Spo(2) target of 88-92% during invasive mechanical ventilation. MEASUREMENTS and MAIN RESULTS: Randomization is 1:1 to a liberal Spo(2) target of more than 94% or a conservative Spo(2) target of 88-92% (inclusive), using minimization with a random component. Minimization will be performed on: age, site, primary reason for admission, and severity of abnormality of gas exchange. Due to the emergency nature of the treatment, approaching patients for written informed consent will be deferred to after randomization. The primary clinical outcome is a composite of death and days of organ support at 30 days. Baseline demographics and clinical status will be recorded as well as daily measures of oxygenation and organ support, and discharge outcomes. This trial received Health Research Authority approval on December 23, 2019 (reference: 272768), including a favorable ethical opinion from the East of England-Cambridge South Research Ethics Committee (reference number: 19/EE/0362). Trial findings will be disseminated in national and international conferences and peer-reviewed journals.
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据