RespiraSense Versus Capnography & Manual Counting

Respiratory Rate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03148873
• Other study ID #: PMD-CS-007
• Status: Completed
• Start date: May 8, 2017
• Est. completion date: June 30, 2017

Study information

• Verified date: August 2018
• Source: PMD Solutions
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Rate

Intervention

Device:
• RespiraSense patient respiratory monitor system
Subjects will have their respiratory rate monitored for two hours using three different methods for capturing it

Locations

Country	Name	City	State
United Kingdom	Ysbyty Gwynedd	Bangor	Wales

Sponsors (1)

Lead Sponsor	Collaborator
PMD Solutions

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RespiraSense versus capnography	Average respiratory rate	15 minute windows for the first hour of monitoring
Secondary	RespiraSense versus manual counting	Average respiratory rate	15 minute windows for the full two hours of monitoring