The Effect of Postoperative Incentive Spirometry on Pulmonary Function and Pulmonary Complications in Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Lahey Clinic
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- Hypoxia 6 Hours Postoperative
研究概览
简要总结
This study evaluates the omission of incentive spirometry use following bariatric surgery. Half of participants will receive an incentive spirometer while the other half will not. Oxygen saturation and pulmonary complications after surgery will be measured to examine the effectiveness of incentive spirometry.
详细描述
Incentive spirometry is speculated to improve pulmonary function in the postoperative period, though data to support this is lacking. Patients undergoing bariatric surgery are at increased risk for pulmonary compromise as they are obese and undergoing foregut surgery.
This study aims to examine the effect of incentive spirometry after bariatric surgery by performing a prospective randomized trial. Subjects will be randomized to either receive an incentive spirometer or not. The primary outcome measure of oxygen saturation off of supplemental oxygen will be taken preoperatively and at 6,12, and 24 hours postoperatively. Secondary outcome measures include rate of pulmonary complications, and time to wean off of supplemental oxygen.
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
- 是
入选标准
- •Patients medically cleared to undergo bariatric surgery per the usual screening process
排除标准
- 未提供
研究组 & 干预措施
Incentive Spirometry
Incentive spirometry 10 times per hour while awake
干预措施: Incentive spirometer (Device)
No Incentive Spirometry
No incentive spirometer provided
干预措施: No incentive spirometer (Device)
结局指标
主要结局
Hypoxia 6 Hours Postoperative
时间窗: 6 hours postoperative
Number of subjects with pulse oximetry reading of \< 92% with subject off of supplemental oxygen for 5 minutes with head of bed at 30°, 6 hours postoperative.
Hypoxia 12 Hours Postoperative
时间窗: 12 hours postoperative
Number of subjects with pulse oximetry reading of \< 92% with subject off of supplemental oxygen for 5 minutes with head of bed at 30°, 12 hours postoperative.
Hypoxia 24 Hours Postoperative
时间窗: 24 hours postoperative
Number of subjects with pulse oximetry reading of \< 92% with subject off of supplemental oxygen for 5 minutes with head of bed at 30°, 24 hours postoperative.
次要结局
- Postoperative Respiratory Complication(entire inpatient say, usually 1 to 7 days)
研究者
Dmitry Nepomnayshy
Assistant Professor of Surgery TUFTS Medical School
Lahey Clinic