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临床试验/NCT03148873
NCT03148873已完成不适用

Evaluation of a Continuous Monitoring Device in Capturing Respiratory Rate Compared to Industry Standard & Gold Standard

PMD Solutions1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2017年5月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
PMD Solutions
入组人数
24
试验地点
1
主要终点
RespiraSense versus capnography

研究概览

简要总结

Your respiratory rate is your number of breaths per minute. The standard way for this to be measured is by a nurse looking at you for one minute and manually counting your breaths over this time. They normally do this once every few hours. At times, it can be useful to have your respiratory rate continuously monitored. A device that can do this is a capnograph. For the patient, this involves wearing a tube in their nose and around their ears while trying to minimise their movement and talking so the measurements can be taken.

This research study is looking at a new respiratory rate monitor and comparing how well it works against the current accepted methods.

Patients who are admitted to the Acute Medical Unit will be invited to participate should they meet all eligibility criteria.

Subjects will be monitored for two hours:

(i) For the first hour subjects will wear a capnograph, RespiraSense and have their respiratory rate manually counted by a research nurse. During this time the subject will be asked to keep talking and moving to a minimum.

(ii) For the second hour subjects will wear RespiraSense and have their respiratory rate manually counted by a research nurse. During this time the subject can talk and move as they wish.

研究设计

研究类型
Observational
观察模型
Other
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

  • ≥18 years
  • Acute admission to be measured within the first 24 hours of this admission episode
  • Are willing to voluntarily sign a statement of informed consent to participate in this investigation

排除标准

  • Allergic to medical grade skin adhesive
  • Pregnant women during second and third trimester
  • Patients who are determined by the medical team to have fragile skin unsuitable for application of the adhesive of the RespiraSense sensor. Patients under the influence of substance abuse (drug or alcohol) that may interfere with their ability to cooperate and comply with the investigation procedures
  • Any disorder, including cognitive dysfunction, which would affect the ability to freely give full informed consent
  • Patients whose health is deteriorating and unstable
  • Patients with predominant palliative care needs
  • Patients with a National Early Warning Score (NEWS) of > 5

结局指标

主要结局

RespiraSense versus capnography

时间窗: 15 minute windows for the first hour of monitoring

Average respiratory rate

次要结局

  • RespiraSense versus manual counting(15 minute windows for the full two hours of monitoring)

研究者

发起方
PMD Solutions
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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