Respiratory Rate Validation Study

NCT ID: NCT05856422

Last Updated: 2024-11-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-05
• Study Completion Date: 2022-12-29

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.

Detailed Description

Each participant is expected to take 1-2 hours, including paperwork, sensor application, and a maximum of 60 minutes of data collection. Each participant will be connected to a commonly used End Tidal Carbon Dioxide monitor (GE Datex-Ohmeda) and the Gabi SmartCare Gabi Band. The end tidal carbon dioxide (EtCO2) monitor will determine performance of respiratory rate metrics (GE Healthcare S5 Compact Monitor with M-COVX (K001814) or E-CaiO (K051092) modules). Each participant will be instrumented with neonatal or pediatric nasal cannula that allows for measurement of the EtCO2. SpO2 sensors may be placed on the feet and/or toes for safety monitoring purposes.

Data will be simultaneously and continuously recorded from the Reference EtCO2 monitor and the Device Under Test (DUT). Periods of quiet will be encouraged. Data will be marked for stable quiet periods that are useable for analysis. There is no additional follow-up required for the investigation.

One minute epochs will be generated from the stable data periods for analysis. For verification, the Reference EtCO2 waveform will be scored by counting the respiratory peaks per minute.

The reviewers counting the raw EtCO2 waveform will be blinded to the results from the test device. The DUT data will be averaged over the corresponding one minute period. The Accuracy root- mean-square (Arms) will be the basis for evaluation and acceptance.

To 'Pass' this test the Gabi SmartCare Gabi Band (Device Under Test) must demonstrate an Accuracy root-mean- square (Arms) of ≤3.0 breaths per minute when compared to the Reference EtCO2 monitor.

The study population will include a minimum of 23 neonates, infants, and pediatrics from 0-12 years of age. A maximum of 60 participants will be enrolled. The participant selection will be an equitable distribution of males and females of any race with varying skin tones. An attempt will be made to include 3 darkly pigmented participants (Fitzpatrick 5 or 6) or 15% of the participant pool (whichever is larger).

The parents or guardian of the participants must understand the study and consent to their child's participation in the study by signing the Informed Consent Form. Subjects 7 to 12 years of age will be provided an Assent. The study will be explained within his/her ability to understand. Participant enrollment and participation in this clinical study is based on meeting the inclusion criteria and none of the exclusion criteria, a satisfactory screening, and the participant and data demographics needed for the study.

Conditions

Measure Accuracy of Respiratory Rate

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Pediatrics population

Group Type: EXPERIMENTAL

Respiratory rate measure based on PPG

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)

• Minimum Eligible Age: 1 Minute
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Gabi SmartCare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinimark LLC

Louisville, Colorado, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

RR3

Identifier Type: -

Identifier Source: org_study_id