Sensor Validation Study - Quality Assurance

PMD Solutions

Status: Completed

Conditions: Respiratory Rate

Treatments: Device: RespiraSense Respiratory Rate Monitor

Study type: Observational

Funder types: Industry

Identifiers

NCT03306537

PMD-CS-011

Details and patient eligibility

About

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

Enrollment: 34 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≥ 18 Years

• Have a BMI ≥35

  • For the sub-group analysis at least 5 subjects with a BMI 35-49 and at least 5 BMI > 50 will be needed

• Are willing to voluntarily sign a statement of informed consent to participate in this investigation

Exclusion criteria

• Allergic to medical grade skin adhesive
• Continuous oral long term steroid use. To be free from oral steroid use this is defined as not using oral steroids in the 4 weeks previous to enrolment
• 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 accurately complete questionnaires and freely give full informed consent