Clinical trial NCT03306537: Sensor Validation Study - Quality Assurance
Official title: A Quality Assurance Study of Respiratory Rate Measurements on Obese Patients With a Novel Monitoring Technology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Rate
Lead sponsor: PMD Solutions
Sponsor class: INDUSTRY
First posted: 2017-10-11
Enrollment: 34
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Obese patients with a BMI ≥35

Brief 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


Eligibility criteria: 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

Primary outcomes:
measure: Comparison of PMD RespiraSense against capnography in obese patients.
timeFrame: 1 hour
Secondary outcomes:
measure: Comparison of PMD RespiraSense in obese patients with BMI below 50 and those with BMI of 50 or above.
timeFrame: 1 hour
measure: Identification of any accuracy spread patterns as BMI increases.
timeFrame: 1 hour
measure: Collection of feedback on device comfort when worn by patients with high BMI.
timeFrame: 1 hour
Other outcomes:
measure: Exploratory: To measure RespiraSense device alarm generation and assess the rationale behind these to determine if false alarms and therefore alarm fatigue is occurring
timeFrame: 1 hour
Locations:
city: Portsmouth
country: United Kingdom
facility: Queen Alexandra Hospital
Study officials:
affiliation: Portsmouth Hospitals NHS Trust
name: Lorraine Albon
role: PRINCIPAL_INVESTIGATOR
References: