Measure Accuracy of Respiratory RateNCT05856422
Respiratory Rate Validation Study
A study testing Respiratory rate measure based on PPG in people with Measure Accuracy of Respiratory Rate, run by Gabi SmartCare at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 minute to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Measure Accuracy of Respiratory Rate
- What is being tested?
- Respiratory rate measure based on PPG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2022to 29 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Respiratory Rate Validation Study - Gabi SmartCare Gabi Band
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.
Read the 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
- Being tested
- Respiratory rate measure based on PPG
- Keywords
- respiratory rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory rate measure based on PPGDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Pediatrics population | Experimental | Not described Receives: Device: Respiratory rate measure based on PPG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Every 60 seconds, over a total duration of maximum 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study start5 Dec 2022
- Primary completion29 Dec 2022
- Study completion29 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Measure Accuracy of Respiratory RateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gabi SmartCare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05856422
- Sponsor's protocol ID
- RR3
- Status last verified
- Nov 2024
- First submitted
- 4 May 2023
- Last updated
- 26 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Rate Validation Study - Gabi SmartCare Gabi Band
- ClinicalTrials.gov ID
- NCT05856422
- Acronym / sponsor ID
- RR3
- Conditions
- Measure Accuracy of Respiratory Rate
- Keywords
- respiratory rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Gabi SmartCareIndustry (pharma, biotech, devices)
- Study start
- 5 Dec 2022 (actual)
- Primary completion
- 29 Dec 2022 (actual)
- Study completion
- 29 Dec 2022 (actual)
- First posted
- 12 May 2023 (actual)
- Results
- Posted 26 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatrics population | Experimental | Device: Respiratory rate measure based on PPG |
Who may qualify
- Ages
- 1 minute to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Respiratory rate measure based on PPGTesting 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. | Device | Pediatrics population |
Primary outcome
Accuracy of Device Under Test for the Measurement of Respiratory Rate, Measured in Breath/Min
Time frame: Every 60 seconds, over a total duration of maximum 60 minutes
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respiratory rate measure based on PPG in people with Measure Accuracy of Respiratory Rate, run by Gabi SmartCare at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of Device Under Test for the Measurement of Respiratory Rate, Measured in Breath/Min (time frame: Every 60 seconds, over a total duration of maximum 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2024.