TelemedicineCARDIASENS_2NCT05240079
Evaluation of a New System for Heart Rate and SpO2 Measurement.
A study testing Heart rate measurement with Caducy system (twice). SpO2 measurement with Caducy system (Twice). in people with Telemedicine, run by Central Hospital, Nancy, France.
Trial summary
Caducy is a new medical device that is able to estimate physiological number such as heart rate and SpO2 via laptop or computer camera. The goal of this study is to evaluate the concordance of Caducy system in reference to gold standard which is a heart rate monitor and an oximeter pod linked to a station of… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Telemedicine
- What is being tested?
- Heart rate measurement with Caducy system (twice). SpO2 measurement with Caducy system (Twice).
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2022to 15 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be 18 years of age or over.
- Patient affiliated to a social security scheme.
- Having received complete information on the organization of the research.
- Able to understand the requirements of the trial and having signed a free and informed consent prior to entering the study
- Patient taken care of by the CUMSAPA (Centre Universitaire de Médecine du Sport et Activité Physique Adaptées) service for an PFT (pulmonary function test), stress test, consultation of adapted physical activity or other functional explorations carried out by the service.
- Patient having carried out a preliminary clinical examination.
Who cannot join
- Acute phenomenon contra-indicating the performance of an PFT, stress test or other functional exploration.
- Person with tremors at the time of clinical examination (Parkinson, spasms...)
- People who cannot present the palms of both hands (amputation).
- Woman of childbearing age who does not have effective contraception.
- Person referred to in Articles L. 1121-5, L. 1121-7 and L1121-8 of the Public Health Code: Pregnant woman, parturient or nursing mother, Minor (non-emancipated), Adult person subject to a legal protection measure (guardianship, curatorship, safeguard of justice), Person of full age unable to express consent
- Persons deprived of their liberty by a judicial or administrative decision, persons undergoing psychiatric treatment under Articles L. 3212-1 and L. 3213-1.
About this study
Official title: Evaluation of Concordance Between the Measurements Obtained by an Acquisition System of Physiological Parameters (Heart Rate/SpO2) Via a Teleconsultation Camera System With Reference to Standard Acquisition Measurements
Caducy is a new medical device that is able to estimate physiological number such as heart rate and SpO2 via laptop or computer camera. The goal of this study is to evaluate the concordance of Caducy system in reference to gold standard which is a heart rate monitor and an oximeter pod linked to a station of acquisition regardless the human variability. The Caducy system measurement via camera is made by filming the visage of the patient during 1 minute.
- Conditions
- Telemedicine
- Being tested
- Heart rate measurement with Caducy system (twice). SpO2 measurement with Caducy system (Twice).
- Keywords
- Telemedicine, Heart rate, photoplethysmography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart rate measurement with Caducy system (twice). SpO2 measurement with Caducy system (Twice).Device
Also called Heart rate measurement with gold standard system (twice). SpO2 measurement with gold standard system (twice).
Heart rate and SpO2 measurement with Caducy (the visage of the subject is filmed 30 seconds and 1 minute with a camera) and heart rate and SpO2 measurement with gold standard (heart rate monitor and oximeter pod linked to an acquisition station). The procedure is repeated twice.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Not described Receives: Device: Heart rate measurement with Caducy system (twice). SpO2 measurement with Caducy system (Twice). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caducy's heart rate measurement compared to standard
Heart rate (bpm) taken with gold standart Heart rate (bpm) calculated by CADUCY
Measured: through study completion, an average of 6 month
Secondary outcomes (1)
Caducy's SpO2 measurement compared to standard
Blood oxygen saturation (%) taken by gold standard Blood oxygen saturation (%) calculated by CADUCY
Measured: through study completion, an average of 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start15 Mar 2022 (estimated)
- Primary completion15 Sep 2023 (estimated)
- Study completion15 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TelemedicineStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05240079
- Sponsor's protocol ID
- 2021-A02217-34
- Acronym
- CARDIASENS_2
- Status last verified
- Nov 2021
- First submitted
- 19 Jan 2022
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Concordance Between the Measurements Obtained by an Acquisition System of Physiological Parameters (Heart Rate/SpO2) Via a Teleconsultation Camera System With Reference to Standard Acquisition Measurements
- ClinicalTrials.gov ID
- NCT05240079
- Acronym / sponsor ID
- CARDIASENS_2 / 2021-A02217-34
- Conditions
- Telemedicine
- Keywords
- Telemedicine, Heart rate, photoplethysmography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 15 Mar 2022 (estimated)
- Primary completion
- 15 Sep 2023 (estimated)
- Study completion
- 15 Nov 2023 (estimated)
- First posted
- 15 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Caducy is a new medical device that is able to estimate physiological number such as heart rate and SpO2 via laptop or computer camera. The goal of this study is to evaluate the concordance of Caducy system in reference to gold standard which is a heart rate monitor and an oximeter pod linked to a station of acquisition regardless the human variability. The Caducy system measurement via camera is made by filming the visage of the patient during 1 minute.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Device: Heart rate measurement with Caducy system (twice). SpO2 measurement with Caducy system (Twice). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be 18 years of age or over.
- Patient affiliated to a social security scheme.
- Having received complete information on the organization of the research.
- Able to understand the requirements of the trial and having signed a free and informed consent prior to entering the study
- Patient taken care of by the CUMSAPA (Centre Universitaire de Médecine du Sport et Activité Physique Adaptées) service for an PFT (pulmonary function test), stress test, consultation of adapted physical activity or other functional explorations carried out by the service.
Key exclusion criteria (6 listed)
- Acute phenomenon contra-indicating the performance of an PFT, stress test or other functional exploration.
- Person with tremors at the time of clinical examination (Parkinson, spasms...)
- People who cannot present the palms of both hands (amputation).
- Woman of childbearing age who does not have effective contraception.
- Person referred to in Articles L. 1121-5, L. 1121-7 and L1121-8 of the Public Health Code: Pregnant woman, parturient or nursing mother, Minor (non-emancipated), Adult person subject to a legal protection measure (guardianship, curatorship, safeguard of justice), Person of full age unable to express consent
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 |
|---|---|---|
| Heart rate measurement with Caducy system (twice). SpO2 measurement with Caducy system (Twice).Also: Heart rate measurement with gold standard system (twice). SpO2 measurement with gold standard system (twice).Heart rate and SpO2 measurement with Caducy (the visage of the subject is filmed 30 seconds and 1 minute with a camera) and heart rate and SpO2 measurement with gold standard (heart rate monitor and oximeter pod linked to an acquisition station). The procedure is repeated twice. | Device | Patients |
Primary outcome
Caducy's heart rate measurement compared to standard
Time frame: through study completion, an average of 6 month
Heart rate (bpm) taken with gold standart Heart rate (bpm) calculated by CADUCY
1 secondary outcome
Caducy's SpO2 measurement compared to standard
Time frame: through study completion, an average of 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2022.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Heart rate measurement with Caducy system (twice). SpO2 measurement with Caducy system (Twice). in people with Telemedicine, run by Central Hospital, Nancy, France.
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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 15 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Caducy's heart rate measurement compared to standard (time frame: through study completion, an average of 6 month). 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 15 Feb 2022.