Oscillating Positive Expiratory Pressure (OPEP) Therapy in Trauma Patients With Multiple Rib Fractures: A Randomized Comparative Trial Against Incentive Spirometry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Time (hours) to stable forced vital capacity
研究概览
简要总结
To determine the efficacy of oscillatory positive expiratory pressure (OPEP) therapy on patients admitted through the trauma service line for rib fractures, as compared to incentive spirometry (IS).
详细描述
Patients identified through screening procedures to fit the inclusion criteria will be approached, within 48 hours of floor admission, to participate in the study. Once written informed consent is obtained, participants will be randomized, in a 1:1 ratio, into either the IS or OPEP study group.
Each patient will be instructed on how to use the respiratory therapy device, either IS or OPEP, by research personnel and respiratory therapists. Participants will be instructed to record their compliance with the RT protocol in their respective patient diaries.
Respiratory Therapy will record FVC three times daily on all study participants until stable (FVC > 1.5L x 4), then daily for up to 7 days or until discharge.
Participants will be contacted on day 30 from discharge, and administered a short questionnaire. All participants will be followed and monitored per standard of care, under the care and supervision of their treating provider teams.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Greater than or equal to 18 years old
- •Greater than or equal to 1 Rib Fracture
- •Admitted to trauma services at Medical Center of the Rockies (MCR).
排除标准
- •Less than 18 years old
- •Any physical injury that creates inability to functionally use devices
- •Adults unable to consent or cooperate due to
- •Confusion
- •On ventilator support
- •Moderate to severe Traumatic brain injury (Glasgow Coma Scale < 12)
- •Cervical spinal cord injury
- •Women who are pregnant
结局指标
主要结局
Time (hours) to stable forced vital capacity
时间窗: 3 times daily, until FVC is >1.5 liters x 4 consecutive tests, or up to 4 weeks
Time (hours) to stable forced vital capacity (FVC) defined as \>1.5 liters x 4 tests and FVC at 7 days for both IS and OPEP participants.
次要结局
未报告次要终点
研究者
Julie Dunn, M.D.
Trauma Research Medical Director
Poudre Valley Health System