RespiraSense Versus Capnography & Manual Counting

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

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Rate
• Intervention / Treatment: Device: RespiraSense patient respiratory monitor system

• Study Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

• United Kingdom
  • Wales
    • Bangor, Wales, United Kingdom, LL57 2PW
      • Ysbyty Gwynedd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The population to be studied are patients that have been admitted to the Acute Medical Unit and to be measured within the first 24 hours of this admission episode either on this unit or on whichever ward they have been transferred to.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RespiraSense versus capnography	Average respiratory rate	15 minute windows for the first hour of monitoring

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RespiraSense versus manual counting	Average respiratory rate	15 minute windows for the full two hours of monitoring

Collaborators and Investigators

• Sponsor: PMD Solutions
• Investigators: Principal Investigator: Christian Subbe, BCUHB

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2017
• Primary Completion (Actual): June 30, 2017
• Study Completion (Actual): June 30, 2017

Study Registration Dates

• First Submitted: May 9, 2017
• First Submitted That Met QC Criteria: May 9, 2017
• First Posted (Actual): May 11, 2017

Study Record Updates

• Last Update Posted (Actual): August 29, 2018
• Last Update Submitted That Met QC Criteria: August 28, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: PMD-CS-007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No