Clinical trial NCT04868630: Calibration of the Average Breathing Rate Measurement of the Cloud DX Pulsewave Health Monitor (PAD-2A) Device (CCV-3)
Official title: Calibration of the Average Breathing Rate Measurement of the Cloud DX Pulsewave Health Monitor (PAD-2A) Device (CCV-3)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Outpatients
Keywords: average breathing rate (breath per minute)
vital sign monitoring
telemedicine
non-invasive device
Lead sponsor: Cardiovascular Research New Brunswick
Sponsor class: OTHER
Collaborators: name: Cloud DX Inc.
name: Horizon Health Network
name: Atlantic Sleep Center
name: New Brunswick Health Research Foundation
name: Dalhousie University
First posted: 2021-05-03
Enrollment: 80
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: For the PAD-2A device calibration phase of the study, we will recruit and consent approximately 80 adult male and female patient participants (≥ 19 years of age; minimum 30% male/female) who are referred to the Atlantic Sleep Centre or the Respiratory Clinic at the Saint John Regional Hospital (SJRH) and who are willing to volunteer to participate in the study. Eligibility of participants will be determined based on the inclusion/exclusion criteria of the study, as described below.

Brief summary: The purpose of this study is to calibrate the average breathing rate measurement of the PAD-2A device to be within ±2 breaths per minute of clinical capnography breathing rate measurements.

Detailed description: The plan for this study is to calibrate the average breathing rate measurement of the PAD-2A device with the breathing rate measurement of a standard clinical capnography device. The data will be collected and analyzed in order to calibrate the PAD-2A device via the capnography measures by adjusting the device algorithm for the breathing rate measurements to be within ±2 breaths per minute. Additionally, the secondary objective of this study is to compare the clinical standard respiratory rate measurement of capnography with the respiratory rate measurements of other standard clinical respiratory devices (i.e. nasal pressure transducer, thermistor, and the respiratory inductance plethysmography (RIP) belts of the chest and abdomen).

Eligibility criteria: Inclusion Criteria:

* Adults ≥ 19 years of age (minimum 30% male/female)
* Wrist circumference between 13.5cm - 23cm (5.3 in. - 9.1in.)

  * Specifically for this test device, the wrist size of the consented participants will be distributed accordingly for a Gaussian distribution:

Lowest Octile: ≥ 13.5cm to \< 14.7cm Lower Quarter: ≥ 13.5cm to \< 15.9cm Lower-Middle Quarter: ≥ 15.9cm to \< 18.3cm Upper-Middle Quarter: ≥ 18.3cm to \< 20.7cm Upper Quarter: ≥ 20.7cm to ≤ 23.0cm Highest Octile: ≥ 21.9cm to ≤ 23.0cm

• Willing to volunteer to participate and to sign the study specific informed consent form

Exclusion Criteria:

* Wrist circumference less than 13.5cm (5.3 in.) or greater than 23cm (9.1 in)
* Hand or body tremors
* Canadian Cardiovascular Society (CCS) grade III or IV angina pectoris (chest pain)
* Unexplained shortness of breath at rest
* History of seizures (except childhood febrile seizures)
* Epilepsy
* History of unexplained syncope (fainting)
* Pregnant
* A musculoskeletal disorder that prevents a non-invasive device to be inflated/deflated on the arm
* Unwilling to volunteer to participate and to sign the study specific informed consent form

Primary outcomes:
measure: Breathing rate
timeFrame: From the start of cuff deflation to the end of cuff deflation (approximately 60 seconds).
measure: Breathing rate
timeFrame: Simultaneous measurement with the PAD-2A wrist cuff device from the start of cuff deflation to the end of cuff deflation (approximately 60 seconds).
measure: Breathing rate
timeFrame: Simultaneous measurement with the PAD-2A wrist cuff device from the start of cuff deflation to the end of cuff deflation (approximately 60 seconds).
measure: Breathing rate
timeFrame: Simultaneous measurement with the PAD-2A wrist cuff device from the start of cuff deflation to the end of cuff deflation (approximately 60 seconds).
Secondary outcomes:
measure: Breathing rate
timeFrame: Simultaneous measurement with the PAD-2A wrist cuff device from the start of cuff deflation to the end of cuff deflation (approximately 60 seconds).
Other outcomes:
Locations:
city: Saint John
country: Canada
facility: Horizon Health Network
state: New Brunswick
Study officials:
affiliation: Atlantic Sleep Centre
name: Graham Bishop, MD, FRCP(C)
role: PRINCIPAL_INVESTIGATOR
References: