Trial Outcomes & Findings for Respiratory Rate Validation Study (NCT NCT05856422)

Last Updated: 2024-11-26

Results Overview

Arms or rms error, given in breath per minute, is the calculation of root mean square between Respiratory rate of the subject device and the manually scored reference Respiratory Rate EtCO2 waveform, for all stable respiratory periods. It is a way of averaging the absolute values of errors over the full measurement range and is a similar measurement to a "rms error". It indicates how far (accurate) the provided value is from the reference used. A passing result required an Arms of ≤3 breaths/min.

Recruitment status

COMPLETED

Target enrollment

24 participants

Primary outcome timeframe

Every 60 seconds, over a total duration of maximum 60 minutes

Results posted on

2024-11-26

Participant Flow

Participant milestones

Participant milestones
Measure	Pediatrics Population Respiratory rate measure based on PPG: Testing was conducted under normal office environment conditions. Each subject was connected to the reference EtCO2 monitor (GE Datex-Ohmeda) and the Device Under Test, the Gabi SmartCare Gabi Band. A waveform collected from an EtCO2 measurement was used to determine performance of respiratory rate metrics. Each subject was given a nasal cannula that allowed for measurement of the EtCO2 respiratory rate. The reference respiratory rate was measured simultaneously with the Device Under Test. Data was marked for stable quiet periods that were useable for analysis.
Overall Study STARTED	21
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Respiratory Rate Validation Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pediatrics Population n=13 Participants Respiratory rate measure based on PPG: Testing was conducted under normal office environment conditions. Each subject was connected to the reference EtCO2 monitor (GE Datex-Ohmeda) and the Device Under Test, the Gabi SmartCare Gabi Band. A waveform collected from an EtCO2 measurement was used to determine performance of respiratory rate metrics. Each subject was given a nasal cannula that allowed for measurement of the EtCO2 respiratory rate. The reference respiratory rate was measured simultaneously with the Device Under Test. Data was marked for stable quiet periods that were useable for analysis.
Age, Categorical <=18 years	13 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	13 Participants n=5 Participants

PRIMARY outcome

Timeframe: Every 60 seconds, over a total duration of maximum 60 minutes

Outcome measures

Outcome measures
Measure	Pediatrics Population n=13 Participants Respiratory rate measure based on PPG: Testing was conducted under normal office environment conditions. Each subject was connected to the reference EtCO2 monitor (GE Datex-Ohmeda) and the Device Under Test, the Gabi SmartCare Gabi Band. A waveform collected from an EtCO2 measurement was used to determine performance of respiratory rate metrics. Each subject was given a nasal cannula that allowed for measurement of the EtCO2 respiratory rate. The reference respiratory rate was measured simultaneously with the Device Under Test. Data was marked for stable quiet periods that were useable for analysis.
Accuracy of Device Under Test for the Measurement of Respiratory Rate, Measured in Breath/Min	2.9 breaths/min

Adverse Events

Pediatrics Population

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Associate Researcher

Clinimark

Phone: 833 373 0998

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place