Multi-site Randomized Clinical Trial of Horizontal Positioning to Prevent and Treat Pulmonary Complications in Mechanically Ventilated Critically Ill Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 主要终点
- Incidence of Pulmonary Complications.
研究概览
简要总结
Intensive care unit (ICU) patients on respirators are at high risk for preventable pulmonary complications (PPC). Turning these patients from side to side may reduce PPC, but carries the burden of decreases in blood pressure and oxygenation. The investigators hypothesize that there will be no difference in PPC or adverse events when ICU patients on respirators are turned by nurses or by an automated turning bed.
详细描述
The purpose of this pilot study is to test the feasibility of two turning protocols and study procedures for a multi-site randomized clinical trial to evaluate efficacy and safety of horizontal positioning interventions to reduce pulmonary complications in mechanically ventilated critically ill adult patients. The hypothesis of the randomized controlled trial (RCT) is no difference in pulmonary complications between manual, 2-hourly lateral rotation to > 45 degrees (control), and continuous automated turning to 45 degrees (experimental) groups.
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
- Single (Outcomes Assessor)
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
- •receiving mechanical ventilation
- •ability to place on study protocol within 8 hours of intubation
排除标准
- •pulmonary mass, pneumothorax, hemothorax, pleural effusion, or other source of compression atelectasis at time of assessment for eligibility
- •systolic blood pressure < 90 mmHg with vasopressor support
- •orthopedic injuries requiring limited or complete immobilization
- •head injury requiring intracranial pressure monitoring
- •unstable spinal injuries
- •rib fractures
- •body weight > 350 lbs
- •intubation within the previous 2 weeks
结局指标
主要结局
Incidence of Pulmonary Complications.
时间窗: Participants were followed for the duration of ICU stay, an average of 10 days.
Number of participants who did not have preventable pulmonary complications (PPC) on pre-study chest radiograph (CXR) and developed PPC during the study period. Pearson Chi-Square test used to test significance of difference between turning groups.
次要结局
- ICU Length of Stay.(Participants were followed for the duration of ICU stay, an average of 10 days.)
- Mechanical Ventilation Duration.(Participants were followed for the duration of mechanical ventilation, an average of 5.5 days.)
- ICU All-cause Mortality.(Participants were followed for the duration of ICU stay, an average of 10 days.)
- Turning-related Events(Participants were followed for the duration of time on protocol, an average of 3.5 days.)
研究者
Sandra K. Hanneman
Professor - UT School of Nursing
The University of Texas Health Science Center, Houston