Cardiac Output MeasurementCLEARSIGHTNCT02717468
Comparative Noninvasive Continuous Cardiac Output by the Clearsight With Invasive Monitoring by Pulsioflex in Abdominal Surgery
A study testing Cardiac output and stroke ejection volume monitoring with arterial waveform analysis in the digital artery (ClearSight®) and Cardiac output and stroke ejection volume monitoring with arterial waveform analysis in the radial artery (Pulsioflex®). in people with Cardiac Output Measurement, run by Poitiers University Hospital at 1 site in France.
Trial summary
In high-risk patients, it is now recommended to guide the intraoperative volume replacement via the stroke volume. Today, the most commonly used technique for estimating the stroke volume is the arterial waveform analysis in the radial artery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Output Measurement
- What is being tested?
- Cardiac output and stroke ejection volume monitoring with arterial waveform analysis in the digital artery (ClearSight®) and Cardiac output and stroke ejection volume monitoring with arterial waveform analysis in the radial artery (Pulsioflex®).
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2016to Feb 2017
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled to undergo major surgery
- Patients monitored by a Pulsioflex® device
Who cannot join
- Patients with heart rhythm disorder
- Patients with Raynaud's disease or vasculitis
- Emergency surgery
- Significant edema fingers
Trial locations and contacts
1 site in 1 country.
About this study
In high-risk patients, it is now recommended to guide the intraoperative volume replacement via the stroke volume.
Today, the most commonly used technique for estimating the stroke volume is the arterial waveform analysis in the radial artery. This technique has the disadvantage of being invasive and increasing the time dedicated to anesthesia during the surgery.
Read more
The future is the non-invasive monitoring of stroke volume. Thus, Edwards Life Science has developed a continuous monitoring technology and non-invasive arterial pressure, cardiac output and stroke volume using a digital sensor (ClearSight®). The continuous monitoring of blood pressure by this technique was validated in cardiothoracic surgery but studies about monitoring cardiac output or stroke volume are inconclusive and contradictory.
The objective of this study is to compare the use of non-invasive monitoring of stroke volume by Clearsight® with the arterial waveform analysis in the radial artery by Pulsioflex® in major surgery.
- Conditions
- Cardiac Output Measurement
- Being tested
- Cardiac output and stroke ejection volume monitoring with arterial waveform analysis in the digital artery (ClearSight®), Cardiac output and stroke ejection volume monitoring with arterial waveform analysis in the radial artery (Pulsioflex®).
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac output and stroke ejection volume monitoring with arterial waveform analysis in the digital artery (ClearSight®)Device
Cardiac output and stroke ejection volume monitoring with arterial waveform analysis in the radial artery (Pulsioflex®).Device
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke Ejection Volume (SEV) measure by ClearSight®
Measured: 24 hours
Stroke Ejection Volume (SEV) measure by Pulsioflex®
Measured: 24 hours
Secondary outcomes (4)
Cardiac Output (CO) measure by ClearSight®
Measured: 24 hours
Cardiac Output (CO) measure by Pulsioflex®
Measured: 24 hours
Stroke Ejection Volume Variations (SVV) measure by ClearSight®
Measured: 24 hours
Stroke Ejection Volume Variations (SVV) measure by Pulsioflex®
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completionDec 2016
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Output MeasurementStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02717468
- Sponsor's protocol ID
- 2015-A01895-44
- Acronym
- CLEARSIGHT
- Status last verified
- Oct 2016
- First submitted
- 18 Feb 2016
- Last updated
- 18 May 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Noninvasive Continuous Cardiac Output by the Clearsight With Invasive Monitoring by Pulsioflex in Abdominal Surgery
- ClinicalTrials.gov ID
- NCT02717468
- Acronym / sponsor ID
- CLEARSIGHT / 2015-A01895-44
- Conditions
- Cardiac Output Measurement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 23 Mar 2016 (estimated)
- 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.
In high-risk patients, it is now recommended to guide the intraoperative volume replacement via the stroke volume.
Today, the most commonly used technique for estimating the stroke volume is the arterial waveform analysis in the radial artery. This technique has the disadvantage of being invasive and increasing the time dedicated to anesthesia during the surgery.
The future is the non-invasive monitoring of stroke volume. Thus, Edwards Life Science has developed a continuous monitoring technology and non-invasive arterial pressure, cardiac output and stroke volume using a digital sensor (ClearSight®). The continuous monitoring of blood pressure by this technique was validated in cardiothoracic surgery but studies about monitoring cardiac output or stroke volume are inconclusive and contradictory.
The objective of this study is to compare the use of non-invasive monitoring of stroke volume by Clearsight® with the arterial waveform analysis in the radial artery by Pulsioflex® in major surgery.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients scheduled to undergo major surgery
- Patients monitored by a Pulsioflex® device
Key exclusion criteria (4 listed)
- Patients with heart rhythm disorder
- Patients with Raynaud's disease or vasculitis
- Emergency surgery
- Significant edema fingers
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 |
|---|---|---|
| Cardiac output and stroke ejection volume monitoring with arterial waveform analysis in the digital artery (ClearSight®) | Device | – |
| Cardiac output and stroke ejection volume monitoring with arterial waveform analysis in the radial artery (Pulsioflex®). | Device | – |
Primary outcome
Stroke Ejection Volume (SEV) measure by ClearSight®
Time frame: 24 hours
Stroke Ejection Volume (SEV) measure by Pulsioflex®
Time frame: 24 hours
4 secondary outcomes
Cardiac Output (CO) measure by ClearSight®
Time frame: 24 hours
Cardiac Output (CO) measure by Pulsioflex®
Time frame: 24 hours
Stroke Ejection Volume Variations (SVV) measure by ClearSight®
Time frame: 24 hours
Stroke Ejection Volume Variations (SVV) measure by Pulsioflex®
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2018.
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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 Cardiac output and stroke ejection volume monitoring with arterial waveform analysis in the digital artery (ClearSight®) and Cardiac output and stroke ejection volume monitoring with arterial waveform analysis in the radial artery (Pulsioflex®). in people with Cardiac Output Measurement, run by Poitiers University Hospital 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 2 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: finished, as of the sponsor's last update on 18 May 2018. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Stroke Ejection Volume (SEV) measure by ClearSight® (time frame: 24 hours). 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 18 May 2018.