NCT04887922终止不适用
The Effect of Preoperative and Postoperative Incentive Spirometry in Patients Undergoing Major Abdominal Surgery
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Change in Forced Expiratory Volume in One Second Parameter (FEV1)
研究概览
简要总结
The goal of this study is to determine the efficacy of incentive spirometry (IS) to improve pulmonary function in the preoperative and postoperative surgical setting. The investigators hypothesize that IS will improve pulmonary function for patients undergoing major abdominal surgery when controlling for protocol compliance. Additionally, the investigators hypothesize that a digital IS device enabled with a text message-based mobile health intervention will improve pulmonary pre-habilitation and rehabilitation, as well as postoperative compliance with the IS device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 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
- •Patients scheduled to undergo major abdominal surgery with expected postoperative length of stay of 48 hours or more.
- •Access to a smartphone.
- •At least 18 years of age.
- •Ability to understand and willingness to sign an IRB approved written informed consent document.
排除标准
- •Younger than 18 years of age
- •No access to a smartphone
研究组 & 干预措施
Pre-Surgery: No Incentive Spirometry (IS)
No Intervention
-Will not receive a incentive spirometer prior to surgery
Pre-Surgery: Standard Incentive Spirometry (IS)
Experimental
- Will receive a conventional spirometer prior to surgery
- Will be asked to perform spirometry 30 times per day.
干预措施: Conventional spirometer (Device)
Pre-Surgery: Digital Incentive Spirometry (IS) + Text Message
Experimental
- Will receive the digital incentive spirometer (Spirobank G) that is compatible with health monitoring software developed by ZEPHYRx®. The digital spirometer couples with a HIPAA-compliant mobile application that calculates and stores pulmonary function test (PFT) results.
- Will be asked to perform spirometry 10 times per hour, every hour while awake, every day for at least 7 days prior to surgery. Absence of spirometry for 24 hours will trigger a text message reminder to encourage compliance with IS.
干预措施: MIR Spirobank G (Device)
Pre-Surgery: Digital Incentive Spirometry (IS) + Text Message
Experimental
- Will receive the digital incentive spirometer (Spirobank G) that is compatible with health monitoring software developed by ZEPHYRx®. The digital spirometer couples with a HIPAA-compliant mobile application that calculates and stores pulmonary function test (PFT) results.
- Will be asked to perform spirometry 10 times per hour, every hour while awake, every day for at least 7 days prior to surgery. Absence of spirometry for 24 hours will trigger a text message reminder to encourage compliance with IS.
干预措施: ZEPHYRx® (Device)
Post-Surgery: Standard Incentive Spirometry (IS)
Active Comparator
- After surgery, the participants will receive a conventional spirometer.
- Will be instructed to perform spirometry 10 times per hour, every hour while awake through postoperative Day 3
- The conventional spirometer will be equipped with an accelerometer that will allow the research team to determine whether the spirometer moves throughout the patients' postoperative stay (as a proxy for IS use)
干预措施: Conventional spirometer (Device)
Post-Surgery: Digital Incentive Spirometry (IS) + Text Message
Experimental
- After surgery, the participants will receive the digital incentive spirometer (Spirobank G) that is compatible with health monitoring software developed by ZEPHYRx®. The digital spirometer couples with a HIPAA-compliant mobile application that calculates and stores pulmonary function test (PFT) results.
- Will be instructed to perform spirometry 10 times per hour, every hour while awake through postoperative Day 3
- Will receive text reminders to perform spirometry if they do not perform spirometry in a 24-hour period.
干预措施: MIR Spirobank G (Device)
Post-Surgery: Digital Incentive Spirometry (IS) + Text Message
Experimental
- After surgery, the participants will receive the digital incentive spirometer (Spirobank G) that is compatible with health monitoring software developed by ZEPHYRx®. The digital spirometer couples with a HIPAA-compliant mobile application that calculates and stores pulmonary function test (PFT) results.
- Will be instructed to perform spirometry 10 times per hour, every hour while awake through postoperative Day 3
- Will receive text reminders to perform spirometry if they do not perform spirometry in a 24-hour period.
干预措施: ZEPHYRx® (Device)
结局指标
主要结局
Change in Forced Expiratory Volume in One Second Parameter (FEV1)
时间窗: From baseline to day-of-surgery preoperative
次要结局
- Change in Pulse Oximetry(From day 1 to postoperative day 3)
- Change in Forced Vital Capacity (FVC)(From day 1 to postoperative day 3)
- Change in Forced Expiratory Volume in One Second Parameter (FEV1)(From day 1 to postoperative day 3)
- Change in Forced Vital Capacity (FVC)(From baseline to day-of-surgery preoperative)
- Change in Pulse Oximetry(From baseline to day-of-surgery preoperative)
研究者
研究点 (1)
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