RespiraSense Versus Capnography & Manual Counting

NCT03148873 | Completed

• 1 other identifier: PMD-CS-007
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Respiratory Rate

Outcome Measures

Primary Outcomes (1)

• RespiraSense versus capnography

  Average respiratory rate

  15 minute windows for the first hour of monitoring

Secondary Outcomes (1)

• RespiraSense versus manual counting

  15 minute windows for the full two hours of monitoring

Interventions

RespiraSense patient respiratory monitor system DEVICE

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

Also known as: Capnograph as comparator - Nonin LifeSense Model LS1-9R

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• PMD Solutions: lead

Study Sites (1)

Ysbyty Gwynedd

Bangor, Wales, LL57 2PW, United Kingdom

Location

Study Officials

• Christian Subbe

  BCUHB

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2017
• First Posted: May 11, 2017
• Study Start: May 8, 2017
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: August 29, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)