Titration of Inspired Oxygen During Mechanical Ventilation Using a Bedside Decision Support Tool
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Duration of Hyperoxemia
研究概览
简要总结
Fractional oxygen during mechanical ventilation, is a life sustaining therapy in the intensive care unit , used for about a million patients annually. Oxygen therapy needs to be tightly balanced as both hypoxia and hyperoxia are harmful. Establishing precision in oxygenation has significant implications for improving patient outcomes, resource utilization and reducing iatrogenic harm to a vulnerable population. The investigators propose an approach using a oxygen titration protocol consisting of electronic health records based alerts to guide oxygen adjustment.
详细描述
The investigators will conduct a prospective randomized, clinical trial in the Medical Intensive Care Unit at Ohio State University Medical Center. In the intervention arm, respiratory therapists' will conduct oxygen titration with the help of a novel, high fidelity, electronic health records based, protocol consisting of electronic alerts and decision support tool. Oxygen titration in the control arm will be done without alerts and will be per "current standard of care".
Participants for this study will be identified and recruited from patients admitted to the Ohio State University, Wexner Medical Center and James Cancer Hospital, Medical Intensive Care Unit.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
In this study providers cannot be masked, outcome assessors and investigators will be blinded
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Critically ill subjects who require mechanical ventilation for at least 24 hours.
排除标准
- •Subjects without research authorization,
- •Pregnancy,
- •Pneumothorax,
- •Carbon monoxide poisoning,
- •Hyperbaric oxygen therapy
- •Acute ST elevation Myocardial Infarction
研究组 & 干预措施
Intervention arm- Oxygen titration with electronic alerts
Oxygen titration will be done based on electronic alerts and decisions support tool by Respiratory Therapists, if FiO2=> 0.4 and SpO2 =>94% for more than 45 minutes
干预措施: Electronic Alerts (Other)
Control Arm- Oxygen titration by one time physician orders
Oxygen titration will be done ventilator management guidelines for the medical intensive care unit. Titration is done by one-time orders.
结局指标
主要结局
Duration of Hyperoxemia
时间窗: Duration of Mechanical Ventilation, an average of 10-14 days
The degree of excess exposure will be recorded as percent FiO2 \>0.4 when saturation continued to remain above 94%. Primary outcome will be determined by the proportion of time the patient will be "exposed to excessive supplied oxygen" divided by the total time under mechanical ventilation.
次要结局
- Ventilator Free days(28 days)
- Duration of stay in the hospital after patient enrollment(Current Hospital Stay, upto 30 days)
- ICU length of stay(days of ICU stay within hospitalization, average of 20-25 days)
研究者
Sonal Pannu
Assistant Professor
Ohio State University