Prevention of Long-Term Respiratory Complications of Spinal Cord Injury: a Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Reductions in episodes of community acquired pneumonia (CAP) and related severe respiratory complications
研究概览
简要总结
It is known that individuals with spinal cord injury are at increased risk for respiratory tract infections like pneumonia. Part of this risk is due to weakened chest and abdominal muscles that are vital to deep breathing and the ability to cough. The purpose of this study is to look at the effectiveness of two different treatments in preventing pneumonia and other respiratory problems in persons with SCI.
This is a randomized controlled trial investigating the effectiveness of two different treatments. Participants will be randomly assigned to one of the two treatment groups. They will not be told the details of the other intervention since this could influence or change their activities during the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic spinal cord injury that occurred more than 6 months ago
- •An impaired ability to cough (cough peak flow less than 300 L/min)
- •Oxygen saturation greater than or equal to 95% when awake and not receiving supplemental oxygen
- •End-tidal carbon dioxide level less than 43 mm Hg
- •Without a fever or other signs of an acute illness for the previous 2 weeks
- •Able to learn the treatment protocol and have someone available at home to assist if needed to help set-up and use the equipment
排除标准
- •Under 18 years of age
- •Currently have a tracheotomy tube
- •Have a history of an acute illness in the last 2 weeks
- •Have lung disease as seen on chest x-ray that results in a baseline oxygen saturation decreasing below 95% during daytime hours and cannot be normalized by usual way of coughing
- •Already utilizing an oximetry protocol
- •Have a significant medical complication and psychiatric condition that would interfere with the conduct of the study or interpretation of the study results.
结局指标
主要结局
Reductions in episodes of community acquired pneumonia (CAP) and related severe respiratory complications
时间窗: 3 years
次要结局
- Impact of respiratory complications on quality of life and participation(3 years)
- Reductions in hospitalizations due to a primary diagnosis of a respiratory complications(3 years)
- Duration of illness and hospitalization(3 years)
研究者
Trevor Dyson-Hudson, M.D.
Interim-Director, Spinal Cord Injury Research
Kessler Foundation