Sensor Validation Study - Quality Assurance

Respiratory Rate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03306537
• Other study ID #: PMD-CS-011
• Status: Completed
• Start date: July 28, 2017
• Est. completion date: September 7, 2018

Study information

• Verified date: March 2019
• Source: PMD Solutions
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: September 7, 2018
• Est. primary completion date: August 7, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Rate

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Queen Alexandra Hospital	Portsmouth

Sponsors (1)

Lead Sponsor	Collaborator
PMD Solutions

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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
Secondary	Collection of feedback on device comfort when worn by patients with high BMI.	Will not be analysed formally.	1 hour