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

Outpatients Clinical Trial

— CCV-3  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04868630
• Other study ID #: RS#: 2020-2908; R#: 100948
• Secondary ID: STP-PW2-001
• Status: Recruiting
• Start date: September 10, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2023
• Source: Cardiovascular Research New Brunswick
• Contact: Christie Aguiar, PhD
• Phone: 506-977-2712
• Email: christie.aguiar[@]clouddx.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Outpatients
• Respiratory Aspiration

Intervention

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

Locations

Country	Name	City	State
Canada	Horizon Health Network	Saint John	New Brunswick

Sponsors (6)

Lead Sponsor	Collaborator
Cardiovascular Research New Brunswick	Atlantic Sleep Center, Cloud DX Inc., Dalhousie University, Horizon Health Network, New Brunswick Health Research Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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).
Primary	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).
Primary	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	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).

External Links

•   Cloud DX device company website.