NCT03306537

Sensor Validation Study - Quality Assurance

A Quality Assurance Study of Respiratory Rate Measurements on Obese Patients With a Novel Monitoring Technology

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 34 (actual)
• Sponsor: PMD Solutions · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2017-07-28
• Primary completion: 2018-08-07
• Completion: 2018-09-07
• First posted: 2017-10-11
• Last updated: 2019-03-20

Locations

1 site across 1 country: United Kingdom