A Prospective Study of the Role and Accuracy of Consumer-Facing Wearable Technology in Gastrointestinal Endoscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 292
- 试验地点
- 2
- 主要终点
- Recorded Arrhythmia Events
研究概览
简要总结
Researchers are assessing the accuracy and safety of wearable technology in subjects undergoing endoscopic gastrointestinal procedures with sedation.
详细描述
This is a prospective, non-blinded, exploratory study to assess the accuracy and safety of wearable devices in the endoscopy suite with patients undergoing procedures using anesthesia assisted sedation using smart watches. We will also simultaneously perform an assessment of patient and provider preferences using narrative-driven, qualitative evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 是
入选标准
- •Adults over 18 years of age.
- •Undergoing anesthesia-assisted endoscopic procedures.
- •Able to give appropriate consent to the study or have an appropriate representative to do so.
排除标准
- •Pregnancy.
- •Physical deformity, wound, or dressing preventing placement of a wearable device on the wrist.
- •Allergy to aluminum, nickel or acrylate.
结局指标
主要结局
Recorded Arrhythmia Events
时间窗: Anesthesia Duration, approximately 30 to 45 minutes
Number of arrhythmia events recorded
Recorded Desaturation Events
时间窗: Anesthesia Duration, approximately 30 to 45 minutes
Number of desaturation events recorded as defined as peripheral O2 saturation \<88%
Recorded Bradycardia Events
时间窗: Anesthesia Duration, approximately 30 to 45 minutes
Number of bradycardia events recorded as defined as heart rate \< 60 bpm
Recorded Tachycardia Events
时间窗: Anesthesia Duration, approximately 30 to 45 minutes
Number of tachycardia events recorded as defined as heart rate \> 100 bpm
Recorded Tachypnea
时间窗: Anesthesia Duration, approximately 30 to 45 minutes
Number of tachypnea events recorded as defined as respiratory rate \>18 breaths per minute
次要结局
未报告次要终点
研究者
Vinay Chandrasekhara
Principal Investigator
Mayo Clinic