Core Warming of COVID-19 Patients Undergoing Mechanical Ventilation: a Randomized, Single Center Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- PaO2/FiO2 Ratio
研究概览
简要总结
The purpose of the proposed pilot study is to determine if core warming improves respiratory physiology of mechanically ventilated patients with COVID-19, allowing earlier weaning from ventilation, and greater overall survival.
详细描述
This is a small scale pilot study to evaluate if core warming improves respiratory physiology of mechanically ventilated patients with COVID-19, allowing earlier weaning from ventilation, and greater overall survival. This prospective, randomized study will include 20 patients diagnosed with COVID-19, and undergoing mechanical ventilation for the treatment of respiratory failure. Patients will be randomized in a 1:1 fashion with 10 patients (Group A) randomized to undergo core warming, and the other 10 patients (Group B) serving as the control group who will not have the ensoETM device used. Patients randomized to Group A will have core warming initiated in the ICU or other clinical environment in which they are being treated after enrollment and provision of informed consent from appropriate surrogate or legally authorized representative.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients above the age of 18 years old.
- •Patients with a diagnosis of COVID-19 on mechanical ventilation.
- •Patient maximum baseline temperature (within previous 12 hours) < 38.3°C.
- •Patients must have a surrogate or legally authorized representative able to understand and critically review the informed consent form.
排除标准
- •Patients without surrogate or legally authorized representative able to provide informed consent.
- •Patients with contraindication to core warming using an esophageal core warming device.
- •Patients known to be pregnant.
- •Patients with <40 kg of body mass.
- •Patients with DNR status.
- •Patients with acute stroke, post-cardiac arrest, or multiple sclerosis.
结局指标
主要结局
PaO2/FiO2 Ratio
时间窗: 0, 24, 48, and 72 hours after initiation of core warming
Determine the change in PaO2/FiO2 ratio at 0, 24, 48, and 72 hours after implementation of core warming of ventilated patients, and compare this change to patients undergoing standard care.
次要结局
- Ventilator-Free Days(Initiation of Core Warming Until Patient Weaned Off Mechanical Ventilation)
- Cycle Threshold at 72-hours(72 hours after initiation of core warming)
- 30-Day Mortality(30 days after initiation of core warming)
研究者
David Willms, MD
Director, Clinical Care Services
Sharp HealthCare