Outpatients
Conditions
Keywords
average breathing rate (breath per minute), vital sign monitoring, telemedicine, non-invasive device
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).
Interventions
This is an observational study of the average breathing rate measurement of a non-invasive wrist cuff device. The purpose of this study is to calibrate the average breathing rate measurement of the Pulsewave Health Monitor (PAD-2A) wrist cuff device with the breathing rate measurement of a standard clinical capnography device. Additionally, we will also compare the average breathing rate measurement of the capnography device with other standard clinical respiratory devices (i.e. nasal pressure transducer, thermistor, and respiratory inductance plethysmography (RIP) belts of the chest and abdomen).
Sponsors
Cloud DX Inc.
Horizon Health Network
Atlantic Sleep Center
New Brunswick Health Research Foundation
Dalhousie University
Cardiovascular Research New Brunswick
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Breathing rate | From the start of cuff deflation to the end of cuff deflation (approximately 60 seconds). | Non-invasive Pulsewave Health Monitor (PAD-2A) wrist cuff device (breaths per minute) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Breathing rate | Simultaneous measurement with the PAD-2A wrist cuff device from the start of cuff deflation to the end of cuff deflation (approximately 60 seconds). | Standard clinical respiratory inductance plethysmography (RIP) belts (breaths per minute) |
Countries
Canada
Contacts
Primary ContactChristie Aguiar, PhD
Backup ContactKeith R. Brunt, PhD
Outcome results
None listed