RespiraSense Versus Capnography & Manual Counting

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.

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Key information

Conditions

Respiratory Rate

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ysbyty Gwynedd

Bangor, Wales, LL57 2PW, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

≥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

Exclusion criteria

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

Treatment and study plan

RespiraSense patient respiratory monitor system

Device

Subjects will have their respiratory rate monitored for two hours using three different methods for capturing it

Other names: Capnograph as comparator - Nonin LifeSense Model LS1-9R

Primary outcomes

RespiraSense versus capnography

Time frame: 15 minute windows for the first hour of monitoring

Average respiratory rate

Secondary outcomes

RespiraSense versus manual counting

Time frame: 15 minute windows for the full two hours of monitoring

Average respiratory rate

Sponsors and collaborators

Lead sponsor

PMD Solutions

Industry

Registry information

Official study title

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

Important dates

Study start: 2017
Primary completion: 2017
Study completion: 2017
First posted: May 11, 2017
Registry last updated: Aug 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed