Evaluating the Effectiveness of Incentive Spirometry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Lifespan
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Compliance - Does the alarm improve IS use compliance?
研究概览
简要总结
Post-operative pulmonary complications (PPCs) have a major impact on patients and healthcare expenses. The goal of perioperative respiratory therapy is to improve airway clearance, increase lung volume, and mitigate atelectasis. Incentive spirometers (IS) are ubiquitously used to prevent atelectasis and PPCs-implementation of which requires substantial provider time and healthcare expenses. However, meta-analyses have demonstrated that the effectiveness of ISs is unclear due to poor patient compliance in past studies.
The goal of this investigation is evaluate the effectiveness of IS on post-operative clinical outcomes. The aims of this investigation are to evaluate 1) if IS use compliance can be improved by adding a use-recording patient reminder alarm, and 2) the clinical outcomes of the more compliant IS users vs. the less-compliant IS users.
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
- Triple (Participant, Care Provider, 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
- •Undergoes any cardiothoracic surgery
- •Is transferred to the cardiothoracic surgery intermediate (step-down) unit at Rhode Island Hospital
- •Already prescribed an incentive spirometer as standard-of-care
- •Followed by any healthcare provider
- •Ability to sign informed consent and comply with all study procedures including follow-up for up to 1 year
排除标准
- •<18 years of age
- •Vulnerable population who in the judgment of the investigator is unable to give Informed Consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy.
研究组 & 干预措施
Bell On
Subjects in the Bell On arm will receive a timer where the alarm will sound every hour.
干预措施: Use-recording, patient-reminder alarm for incentive spirometry (Behavioral)
Bell Off
Subjects in the Bell Off arm will receive a timer where the alarm will not sound, but still record incentive spirometer usage
干预措施: Use-recording, patient-reminder alarm for incentive spirometry (Behavioral)
结局指标
主要结局
Compliance - Does the alarm improve IS use compliance?
时间窗: up to 1 week postoperatively
The primary outcome will be to compare subjects' absolute IS usage count and hourly percent compliance in the Bell On arm vs the Bell Off arms.
次要结局
- Outcomes - Does IS use compliance improve clinical outcomes?(up to 1 week postoperatively)