Sensor Validation Study - Quality Assurance

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

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

Study Overview

• Status: Completed
• Conditions: Respiratory Rate
• Intervention / Treatment: Device: RespiraSense Respiratory Rate Monitor

• Study Type: Observational
• Enrollment (Actual): 34

Contacts and Locations

Study Locations

• United Kingdom
  • Portsmouth, United Kingdom, PO6 3LY
    • Queen Alexandra Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Obese patients with a BMI ≥35

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of PMD RespiraSense against capnography in obese patients.	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.	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of PMD RespiraSense in obese patients with BMI below 50 and those with BMI of 50 or above.	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.	1 hour
Identification of any accuracy spread patterns as BMI increases.	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.	1 hour
Collection of feedback on device comfort when worn by patients with high BMI.	Will not be analysed formally.	1 hour

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: PMD Solutions
• Investigators: Principal Investigator: Lorraine Albon, Portsmouth Hospitals NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2017
• Primary Completion (Actual): August 7, 2018
• Study Completion (Actual): September 7, 2018

Study Registration Dates

• First Submitted: September 29, 2017
• First Submitted That Met QC Criteria: October 10, 2017
• First Posted (Actual): October 11, 2017

Study Record Updates

• Last Update Posted (Actual): March 20, 2019
• Last Update Submitted That Met QC Criteria: March 19, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: PMD-CS-011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No