Respiratory Rate Validation Study

NCT05856422 | Completed Results

• 1 other identifier: RR3
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to conduct a Respiratory Rate accuracy validation on pediatrics population comparing the Gabi SmartCare Gabi Band to the Reference, an FDA cleared End Tidal Carbon Dioxide monitor (GE Datex- Ohmeda) by manually scoring the collected waveform for data analysis.

Conditions

Measure Accuracy of Respiratory Rate

Keywords

respiratory rate

Outcome Measures

Primary Outcomes (1)

• Accuracy of Device Under Test for the Measurement of Respiratory Rate, Measured in Breath/Min

  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.

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

Study Arms (1)

Pediatrics population

EXPERIMENTAL

Device: Respiratory rate measure based on PPG

Interventions

Respiratory rate measure based on PPG DEVICE

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.

Pediatrics population

Eligibility Criteria

• Age: 1 Minute - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Ability of the parent or guardian to understand and provide written informed consent
• Participant is 0 to 12 years of age
• Subjects that are between 7 and 12 years of age must provide Assent to participate in the study

You may not qualify if:

• Participants evaluated by the Investigator and Clinical Staff and found to be medically unsuitable or have self-reported health conditions that are currently unstable as identified in the Participant Demographics and Screening Record Form
• Participant has injuries, deformities or abnormalities that may prevent proper application of the device under test
• Participants with severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, ECG electrodes, or other medical sensors (self-reported)

Sponsors & Collaborators

• Gabi SmartCare: lead

Study Sites (1)

Clinimark LLC

Louisville, Colorado, 80027, United States

Location

Results Point of Contact

• Title: Associate Researcher
• Organization: Clinimark

Carolyn.Cohen@element.com

833 373 0998

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: May 12, 2023
• Study Start: December 5, 2022
• Primary Completion: December 29, 2022
• Study Completion: December 29, 2022
• Last Updated: November 26, 2024
• Results First Posted: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)