Cardiac OutputSCHOTTNCT04007146
Systematic Calculation of HyperOxygenation Transit Time
A study testing Transcutaneous oxymetry measurement in people with Cardiac Output, run by University Hospital, Angers at 1 site in France.
Trial summary
Cardiac output (CO) is an essential physiological parameter of healthy person or illness. In clinical practices, all methods of measuring the CO(Fick method, thoracic impedance, esophageal echodoppler etc) contain limit. Each method are dangerous or hard to implement. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiac Output
- What is being tested?
- Transcutaneous oxymetry measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2020to 1 Sep 2021
- 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
- Adults over 18
- Cardiac output measurement considered at least 2 hours prior to the study
- Affiliation to a French National healthcare system
- Written informed consent must be obtained prior to protocol-specific
Who cannot join
- Acute or decompensated cardiac or respiratory failure
- Allergy to medical adhesives
- Patients under reinforced protection, pregnancy, deprived of liberty by judicial or administrative decision, hospitalized without consent or admitted to a health or social establishment for purposes other than research
- Inability to understand the instructions or objectives of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Systematic Calculation of HyperOxygenation Transit Time Mesure transcutanée de l'oxygène au Cours de l'Hyperoxie Transitoire
Cardiac output (CO) is an essential physiological parameter of healthy person or illness.
In clinical practices, all methods of measuring the CO(Fick method, thoracic impedance, esophageal echodoppler etc) contain limit. Each method are dangerous or hard to implement.
CO is probably determining element of blood transit time and thus the availability of oxygen between the central organs (heart, lung) and the peripheral organs (leg, arms).
Our hypothesis is transcutaneous oxymetry mesurement with oxygen inhalation, to cause a transient hyperoxia, can be used to determinate blood transit time between central organs and peripheral organs. This simple method will be non invasive technique.
Read the detailed description
At admission eligible patients are proposed to participate. Written consent is signed after complete oral and written explanation of the protocol is signed.
The time of onset hyperoxia will be compare to usual CO method by cross correlation.
The duration of participation for subject is equal to 1 hour.
- Conditions
- Cardiac Output
- Being tested
- Transcutaneous oxymetry measurement
- Keywords
- Cardiac Output, vascular medicine, Transcutaneous Oxymetry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous oxymetry measurementDiagnostic test
Transcutaneous oxymetry measurement with transient hyperoxia period (2 periods of 30seconds at 60% of oxygen)
| Study group | Role | What they receive |
|---|---|---|
| Cardiac Output Measurement | Experimental | Subject will have a usual cardiac output Receives: Diagnostic Test: Transcutaneous oxymetry measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimation of transcutaneous oxymetry with transient hyperoxia
Transition time calcutation from oxygen to peripheral organs by transcutaneous oxymetry method.
Measured: 24 months
Average of CO measured
Average of CO by usual method (catheterisation or transoesophageal echocardiography) reported in medical record of patients
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start1 Mar 2020
- Primary completion1 Sep 2021
- Study completion1 Sep 2021
Why it stopped: With Covid period, inclusions can't be efficient.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac OutputStudies 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
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Pierre MD ABRAHAM, PhD, Principal investigator, University Hospital in Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04007146
- Sponsor's protocol ID
- 2019-002571-33
- Other IDs
- 2019
- Acronym
- SCHOTT
- Status last verified
- Nov 2021
- First submitted
- 28 Jun 2019
- Last updated
- 8 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic Calculation of HyperOxygenation Transit Time Mesure transcutanée de l'oxygène au Cours de l'Hyperoxie Transitoire
- ClinicalTrials.gov ID
- NCT04007146
- Acronym / sponsor ID
- SCHOTT / 2019-002571-33
- Conditions
- Cardiac Output
- Keywords
- Cardiac Output, vascular medicine, Transcutaneous Oxymetry
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: With Covid period, inclusions can't be efficient.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 5 Jul 2019 (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.
Cardiac output (CO) is an essential physiological parameter of healthy person or illness.
In clinical practices, all methods of measuring the CO(Fick method, thoracic impedance, esophageal echodoppler etc) contain limit. Each method are dangerous or hard to implement.
CO is probably determining element of blood transit time and thus the availability of oxygen between the central organs (heart, lung) and the peripheral organs (leg, arms).
Our hypothesis is transcutaneous oxymetry mesurement with oxygen inhalation, to cause a transient hyperoxia, can be used to determinate blood transit time between central organs and peripheral organs. This simple method will be non invasive technique.
Detailed description
At admission eligible patients are proposed to participate. Written consent is signed after complete oral and written explanation of the protocol is signed.
The time of onset hyperoxia will be compare to usual CO method by cross correlation.
The duration of participation for subject is equal to 1 hour.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac Output Measurement | Experimental | Diagnostic Test: Transcutaneous oxymetry measurementSubject will have a usual cardiac output |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults over 18
- Cardiac output measurement considered at least 2 hours prior to the study
- Affiliation to a French National healthcare system
- Written informed consent must be obtained prior to protocol-specific
Key exclusion criteria (4 listed)
- Acute or decompensated cardiac or respiratory failure
- Allergy to medical adhesives
- Patients under reinforced protection, pregnancy, deprived of liberty by judicial or administrative decision, hospitalized without consent or admitted to a health or social establishment for purposes other than research
- Inability to understand the instructions or objectives of the study
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 |
|---|---|---|
| Transcutaneous oxymetry measurementTranscutaneous oxymetry measurement with transient hyperoxia period (2 periods of 30seconds at 60% of oxygen) | Diagnostic test | Cardiac Output Measurement |
Primary outcome
Estimation of transcutaneous oxymetry with transient hyperoxia
Time frame: 24 months
Transition time calcutation from oxygen to peripheral organs by transcutaneous oxymetry method.
Average of CO measured
Time frame: 24 months
Average of CO by usual method (catheterisation or transoesophageal echocardiography) reported in medical record of patients
Results and safety
The study was stopped early (reason given: With Covid period, inclusions can't be efficient.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2021.
- Individual participant dataSharing planned: No
Related trials for Cardiac Output
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Influence of Lung Volume Optimization Maneuver on Cardiac Output and Lung Compliance in Ventilated Children With Congenital Heart Disease Undergoing Surgical Repair
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Ivabradine for Heart Rate Reduction During Exercise in Healthy Adults
Healthy Adult
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Validation of Continuous Transcutaneous Carbon Dioxide Monitoring in VA-ECMO Patients
Carbon Dioxide
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Effect of Systematic and Sequential Leg Elevation on Cardiac Output in Healthy Volunteers
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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.
Pierre MD ABRAHAM, PhD principal investigator
University Hospital in Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous oxymetry measurement in people with Cardiac Output, run by University Hospital, Angers at 1 site in 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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 8 Dec 2021. 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 France. 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?
The study was stopped early (reason given: With Covid period, inclusions can't be efficient.). 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?
Estimation of transcutaneous oxymetry with transient hyperoxia (time frame: 24 months). The study lists 2 primary outcomes in all. 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 8 Dec 2021.