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临床试验/NCT07537478
NCT07537478已完成不适用

Respiration Measured Via End-tidal CO2 and Spirometry Study

Boston Scientific Corporation2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年5月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Respiratory rate detection - end tidal CO2

研究概览

简要总结

To collect respiration data via end-tidal CO2 and spirometry and compare respiration rates measured via the two methods.

详细描述

This is a non-randomized, data collection study that will enroll up to 50 participants.

There will be one study visit per participant and no follow up period.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Willing and able to provide informed consent
  • Age 18 or above
  • Full time or part time BSC employee
  • Willing and able to participate in the required testing

排除标准

  • Currently enrolled in another clinical trial that might interfere with data collection or placement of the study system
  • Subject is pregnant as indicated by subject report
  • Known allergy or sensitivity to materials used in the study (Neoprene, Nylon)
  • Any past or current medical event that could represent a risk for the subject to perform the study required activities in the opinion of the investigator

研究组 & 干预措施

Wearable respiration mask - Exercise

Healthy control subjects eligible for exercise.

干预措施: Wearable Respiration mask - exercise (Device)

Wearable respiration mask

Healthy control subjects not eligible for exercise.

干预措施: Wearable respiration Mask (Device)

结局指标

主要结局

Respiratory rate detection - end tidal CO2

时间窗: From enrollment through the end of the data collection visit, expected to take up to 3 hours.

End-Tidal CO2 will be measured as a fractional concentration (volume percent of CO₂ in exhaled gas).

次要结局

  • Respiratory rate detection - spirometry(From enrollment through the data collection visit, up to 3 hours.)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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