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

Recruiting

• Conditions: Outpatients
• Interventions: Device: Pulsewave Health Monitor (PAD-2A) Device

• Registration Number: NCT04868630
• Lead Sponsor: Cardiovascular Research New Brunswick

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).

Study Timeline

• Study First Submitted: 2021-04-21
• Study First Submitted QC: 2021-04-27
• Study First Posted: 2021-05-03
• Study Start: 2021-09-10
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-16
• Last Update Posted: 2023-02-21
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Outpatients; Atlantic Sleep Centre & SJRH Respiratory Clinic	Pulsewave Health Monitor (PAD-2A) Device	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.

Primary Outcome Measures

Name	Time	Method
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 thermistor via nasal cannula (breaths per minute)

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Horizon Health Network; 🇨🇦 Saint John, New Brunswick, Canada