Sensor Validation Study - Quality Assurance

NCT03306537 | Completed

• 1 other identifier: PMD-CS-011
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

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

Conditions

Respiratory Rate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Comparison of PMD RespiraSense in obese patients with BMI below 50 and those with BMI of 50 or above.

  1 hour

• Identification of any accuracy spread patterns as BMI increases.

  1 hour

• Collection of feedback on device comfort when worn by patients with high BMI.

  1 hour

Other Outcomes (1)

• 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

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

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Obese patients with a BMI ≥35

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• PMD Solutions: lead

Study Sites (1)

Queen Alexandra Hospital

Portsmouth, PO6 3LY, United Kingdom

Location

Study Officials

• Lorraine Albon

  Portsmouth Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2017
• First Posted: October 11, 2017
• Study Start: July 28, 2017
• Primary Completion: August 7, 2018
• Study Completion: September 7, 2018
• Last Updated: March 20, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)