MedTrace Logo

Sensor Validation Study - Quality Assurance

NCT03306537 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 34

Last updated 2019-03-20

No results posted yet for this study

Summary

The respiratory rate is an important parameter in clinical medicine. It is defined as the number of breaths per minute. Currently this is measured at the bedside in clinical practice by counting the breaths, however the gold standard for measuring this vital sign is the 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 that the measurements can be taken.

A new respiratory rate monitor, RespiraSense, is non-invasive and measures the respiratory rate by measuring the displacement between the ribs and abdomen. This research study is intended to validate that this technology is effective and accurate on people with a bigger body mass.

Subjects with a BMI \> 35 will be invited to participate should they meet all of the eligibility criteria. If patients agree to participate, following informed consent, subjects will be monitored for one hour with both the capnograph and RespiraSense measuring at the same time so their results can be compared

Conditions

  • Respiratory Rate

Interventions

DEVICE

RespiraSense Respiratory Rate Monitor

RespiraSense device will be attached at the same time as the capnograph (gold standard) and both will measure simultaneously for one hour

Sponsors & Collaborators

  • PMD Solutions

    lead INDUSTRY

Principal Investigators

  • Lorraine Albon · Portsmouth Hospitals NHS Trust

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-28
Primary Completion
2018-08-07
Completion
2018-09-07

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03306537 on ClinicalTrials.gov