Sensor Validation Study - Quality Assurance

NCT03306537 — Completed, 34 participants, PMD Solutions

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

Registry	NCT03306537
Status	Completed
Study type	Observational
Enrollment	34 (Actual)
Sponsor	PMD Solutions (Industry)
Conditions	Respiratory Rate
Interventions	RespiraSense Respiratory Rate Monitor (Device)
Dates	start 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 in United Kingdom

-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

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+Arms and interventions

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

+Outcome measures

Primary outcomes

Comparison of PMD RespiraSense against capnography in obese patients. [1 hour]: Analysed using a Bland Altman (BA) analysis to measure limits of agreement between both methods. The BA analysis will correct for repeated measures within each subject if required. In addition, a Deming Regression will be performed on the collected data.

Secondary outcomes

Comparison of PMD RespiraSense in obese patients with BMI below 50 and those with BMI of 50 or above. [1 hour]: Analysed using a Bland Altman (BA) analysis to measure limits of agreement between both methods. The BA analysis will correct for repeated measures within each subject if required. In addition, a Deming Regression will be performed on the collected data.
Identification of any accuracy spread patterns as BMI increases. [1 hour]: Analysed using a Bland Altman (BA) analysis to measure limits of agreement between both methods. The BA analysis will correct for repeated measures within each subject if required. In addition, a Deming Regression will be performed on the collected data.
Collection of feedback on device comfort when worn by patients with high BMI. [1 hour]: Will not be analysed formally.

Other outcomes

Exploratory: To measure RespiraSense device alarm generation and assess the rationale behind these to determine if false alarms and therefore alarm fatigue is occurring [1 hour]: Will not be analysed formally.

+Eligibility

Sex: All, ages: any to 18 Years

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

+Locations (1)

Facility	City	Country	Status
Queen Alexandra Hospital	Portsmouth	United Kingdom

+Investigators

Lorraine Albon, Principal investigator, Portsmouth Hospitals NHS Trust

My Notes

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