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

Cardiovascular Research New Brunswick

Status: Enrolling

Conditions: Outpatients

Treatments: Device: Pulsewave Health Monitor (PAD-2A) Device

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04868630

RS#: 2020-2908 R#: 100948;

STP-PW2-001 (Other Identifier)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 80 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

80 participants in 1 patient group

Outpatients; Atlantic Sleep Centre & SJRH Respiratory Clinic

Description:

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.

Treatment:

Device: Pulsewave Health Monitor (PAD-2A) Device