Calibration of the Average Breathing Rate Measurement of the Cloud DX Pulsewave Health Monitor (PAD-2A) Device (CCV-3)

Study Overview
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Brief Summary
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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
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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).

Official Title
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Calibration of the Average Breathing Rate Measurement of the Cloud DX Pulsewave Health Monitor (PAD-2A) Device (CCV-3)

Conditions
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Outpatients

Intervention / Treatment
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* Device: Pulsewave Health Monitor (PAD-2A) Device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Outpatients; Atlantic Sleep Centre & SJRH Respiratory Clinic<br>The study population consists of approximately 80 adult, outpatient participants recruited from the Atlantic Sleep Centre and the Respiratory Clinic at the Horizon Health Network, Saint John Regional Hospital. | Device: Pulsewave Health Monitor (PAD-2A) Device<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breathing rate | Non-invasive Pulsewave Health Monitor (PAD-2A) wrist cuff device (breaths per minute) | From the start of cuff deflation to the end of cuff deflation (approximately 60 seconds). | 
| Breathing rate | Standard clinical capnograph device via nasal cannula (breaths per minute) | Simultaneous measurement with the PAD-2A wrist cuff device from the start of cuff deflation to the end of cuff deflation (approximately 60 seconds). | 
| Breathing rate | Standard clinical nasal pressure transducer via nasal cannula (breaths per minute) | Simultaneous measurement with the PAD-2A wrist cuff device from the start of cuff deflation to the end of cuff deflation (approximately 60 seconds). | 
| Breathing rate | Standard clinical thermistor via nasal cannula (breaths per minute) | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breathing rate | Standard clinical respiratory inductance plethysmography (RIP) belts (breaths per minute) | Simultaneous measurement with the PAD-2A wrist cuff device from the start of cuff deflation to the end of cuff deflation (approximately 60 seconds). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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average breathing rate (breath per minute), vital sign monitoring, telemedicine, non-invasive device