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

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ClinicalTrials.gov Identifier: NCT04868630
Recruitment Status : Recruiting
First Posted : May 3, 2021
Last Update Posted : September 20, 2021
Sponsor:
Collaborators:
Cloud DX Inc.
Horizon Health Network
Dalhousie University
New Brunswick Health Research Foundation
Information provided by (Responsible Party):
Sohrab Lutchmedial, MD, FRCPC, 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.

Condition or disease Intervention/treatment
Outpatients Device: Pulsewave Health Monitor (PAD-2A) Device

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).

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Calibration of the Average Breathing Rate Measurement of the Cloud DX Pulsewave Health Monitor (PAD-2A) Device (CCV-3)
Actual Study Start Date : September 10, 2021
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : September 30, 2022

Group/Cohort Intervention/treatment
Outpatients; Atlantic Sleep Centre & SJRH Respiratory Clinic
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
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).




Primary Outcome Measures :
  1. Breathing rate [ Time Frame: 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)

  2. Breathing rate [ Time Frame: 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 capnograph device via nasal cannula (breaths per minute)

  3. Breathing rate [ Time Frame: 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 nasal pressure transducer via nasal cannula (breaths per minute)

  4. Breathing rate [ Time Frame: 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 :
  1. Breathing rate [ Time Frame: 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)



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
For the PAD-2A device calibration phase of the study, we will recruit and consent approximately 80 adult male and female patient participants (≥ 19 years of age; minimum 30% male/female) who are referred to the Atlantic Sleep Centre or the Respiratory Clinic at the Saint John Regional Hospital (SJRH) and who are willing to volunteer to participate in the study. Eligibility of participants will be determined based on the inclusion/exclusion criteria of the study, as described below.
Criteria

Inclusion Criteria:

  • Adults ≥ 19 years of age (minimum 30% male/female)
  • Wrist circumference between 13.5cm - 23cm (5.3 in. - 9.1in.)

    • At least 20% of total participants, greater than 20.6cm
    • At least 20% of total participants, between 18.3cm & 20.6cm
    • At least 20% of total participants, between 15.9cm & 18.3cm
    • At least 20% of total participants, less than 15.9cm
    • At least 10% of total participants, greater than 21.8cm
    • At least 10% of total participants, less than 14.7cm
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04868630


Contacts
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Contact: Sohrab Lutchmedial, MD, FRCP(C) 506-648-6101 sohrab.lutchmedial@horizonnb.ca
Contact: Keith R. Brunt, PhD 506-636-6974 keith.brunt@dal.ca

Locations
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Canada, New Brunswick
Horizon Health Network Recruiting
Saint John, New Brunswick, Canada
Sponsors and Collaborators
Cardiovascular Research New Brunswick
Cloud DX Inc.
Horizon Health Network
Dalhousie University
New Brunswick Health Research Foundation
Investigators
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Principal Investigator: Glendon Sullivan, MD Atlantic Sleep Centre
Additional Information:
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Responsible Party: Sohrab Lutchmedial, MD, FRCPC, Co-Director of CVR-NB/ Director of the New Brunswick Heart Centre (NBHC) Cardiac Catheterization Laboratory, Cardiovascular Research New Brunswick
ClinicalTrials.gov Identifier: NCT04868630    
Other Study ID Numbers: RS#: 2020-2908; R#: 100948
STP-PW2-001 ( Other Identifier: Health Canada )
First Posted: May 3, 2021    Key Record Dates
Last Update Posted: September 20, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Currently, the clinical research group is undecided regarding individual participant data (IPD) sharing with other researchers upon completion of this study, although it is acknowledged that the practice of data sharing among scientists, clinicians, and other professionals is of increasing importance, particularly for transparency in clinical research studies.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Sohrab Lutchmedial, MD, FRCPC, Cardiovascular Research New Brunswick:
average breathing rate (breath per minute)
vital sign monitoring
telemedicine
non-invasive device
Additional relevant MeSH terms:
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Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes