Reminder-enhanced Incentive Spirometry Evaluation (RISE)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 88
- 主要终点
- Median IS breaths per hour
研究概览
简要总结
The purpose of this study is to test whether automatic reminders with a light and a soft sound help patients improve deep breathing exercises after surgery. These breathing exercises are routinely done with the help of a plastic device that you attach to your mouth and you take a deep breath. These exercises are routinely recommended after major surgery to improve the oxygen level in your blood and reduce other respiratory problems.
详细描述
The goal of this project is to evaluate whether automatic reminders increase incentive spirometry performance (IS) and reduce hypoxemia during the first three postoperative days after inpatient non-cardiac surgery in patients with a preoperative ARISCAT risk score ≥26.
This three-center pilot study will first test the effectiveness of automatic IS reminders, compared to no reminders, on the quality of performance for three postoperative days after inpatient non-cardiac surgery. Then we will estimate the effect size of IS reminders on postoperative hypoxemia and other complications.
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
- Single (Outcomes Assessor)
盲法说明
The data analyst will be blinded of which participants received breathing exercise reminders and those who did not.
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
- •≥18 years
- •Planned non-cardiac surgery under general anesthesia with at least one night of hospitalization expected
- •Preoperative ARISCAT risk score ≥26
- •Signed informed consent
排除标准
- •Inability to perform IS due to refusal, cognitive impairment, neuromuscular weakness, anatomical, or any other reasons (e.g., tracheotomy, oral surgery, unable to hold incentive spirometer)
- •Have a severe hearing or visual acuity impairment that prevents them from hearing or seeing the audible and visual IS reminders
- •Are part of a vulnerable population (minors, pregnant, prisoners)
- •Lack of informed consent
研究组 & 干预措施
Alarms ON
A soft buzz and blinking light emitted from the incentive spirometer base attachment (monitor) will go off every twenty minutes during waking hours after major surgery.
干预措施: Alarms ON (Device)
Alarms OFF
The patient will be given an incentive spirometer with the base attachment (monitor). No light or soft buzz will be emitted from the device.
结局指标
主要结局
Median IS breaths per hour
时间窗: Post-Anesthesia Care Unit (PACU) admission to postoperative day 3 (POD3)
Median adequate IS breaths per hour within eligible hours of all patients in each reminder group
次要结局
未报告次要终点
研究者
Ana Fernandez-Bustamante, MD, PhD
Ana Fernandez-Bustamante, MD, PhD
University of Colorado, Denver