Ignite Creation Date:
2024-05-06 @ 4:04 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04868630
Status:
RECRUITING
Last Update Posted:
2023-02-21
First Post:
2021-04-21
Brief Title:
Calibration of the Average Breathing Rate Measurement of the Cloud DX Pulsewave Health Monitor PAD-2A Device CCV-3
Sponsor:
Cardiovascular Research New Brunswick
Organization:
Cardiovascular Research New Brunswick
Study Overview
Official Title:
Calibration of the Average Breathing Rate Measurement of the Cloud DX Pulsewave Health Monitor PAD-2A Device CCV-3
Status:
RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CCV-3
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 ie nasal pressure transducer thermistor and the respiratory inductance plethysmography RIP belts of the chest and abdomen
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| STP-PW2-001 | OTHER | Health Canada | None |