Cardiac OutputNEXFINNCT03114579
Evaluation of the Measurement of Cardiac Output by the NEXFIN HD Monitor in Peroperative
A study testing Intraoperative heart rate measurement (reference method) and NEXFIN HD in people with Cardiac Output and Peroperative, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Continuous perioperative cardiac output (DC) and blood pressure (PA) monitoring contributes to hemodynamic stability and ensures adequate perfusion pressure, resulting in a reduction in morbidity and mortality and length of hospital stay. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Output, Peroperative
- What is being tested?
- Intraoperative heart rate measurement (reference method) and NEXFIN HD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- 11 Feb 2015to 11 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
- Adult patients candidate for surgery under general anesthesia requiring oesophageal Doppler or arterial catheter hemodynamic monitoring.
Who cannot join
- Patients with cardiac and thoracic surgery,
- patients for whom access to the head is impossible,
- facial trauma patients,
- patients with aortic malformation, dilation or coarctation,
- patients with aortic dissection,
- patients with vascular surgery with aortic clamping,
Show all 10Show fewer
- patients with a tumor, stenosis or varices of the esophagus,
- patients with severe oesophagitis,
- patients with thoracic radiotherapy
- patients under guardianship or curatorship or deprived of liberty.
Trial locations and contacts
1 site in 1 country.
About this study
Continuous perioperative cardiac output (DC) and blood pressure (PA) monitoring contributes to hemodynamic stability and ensures adequate perfusion pressure, resulting in a reduction in morbidity and mortality and length of hospital stay.
The monitors usually used in perioperative are either semi-invasive and difficult for calibration (oesophageal Doppler) or invasive (arterial catheter).
The Nexfin HD allows these two measurements and it is completely non-invasive, remains to validate its use in peroperative.
- Conditions
- Cardiac Output, Peroperative
- Being tested
- Intraoperative heart rate measurement (reference method), NEXFIN HD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative heart rate measurement (reference method)Device
Measurement of cardiac output by both monitors: NEXFIN HD and oesophageal doppler, blood pressure measurement by the catheter and NEXFIN HD monitor, and cardiac output and blood pressure measurements after treatment administration (vasoconstrictor or filling)
NEXFIN HDDevice
| Study group | Role | What they receive |
|---|---|---|
| Measure of the cardiac output obtained by a reference methode | Other | Not described Receives: Device: Intraoperative heart rate measurement (reference method) |
| Measurement of cardiac output obtained by NEXFIN HD. | Other | Not described Receives: Device: NEXFIN HD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival defines as the time between the date of surgery and death or date of last news
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start11 Feb 2015
- Primary completion11 Feb 2017
- Study completion11 Feb 2017
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.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03114579
- Sponsor's protocol ID
- PI2014_843_0005
- Acronym
- NEXFIN
- Status last verified
- Apr 2017
- First submitted
- 5 Apr 2017
- Last updated
- 14 Apr 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Measurement of Cardiac Output by the NEXFIN HD Monitor in Peroperative
- ClinicalTrials.gov ID
- NCT03114579
- Acronym / sponsor ID
- NEXFIN / PI2014_843_0005
- Conditions
- Cardiac Output, Peroperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 11 Feb 2015 (actual)
- Primary completion
- 11 Feb 2017 (actual)
- Study completion
- 11 Feb 2017 (actual)
- First posted
- 14 Apr 2017 (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.
Continuous perioperative cardiac output (DC) and blood pressure (PA) monitoring contributes to hemodynamic stability and ensures adequate perfusion pressure, resulting in a reduction in morbidity and mortality and length of hospital stay.
The monitors usually used in perioperative are either semi-invasive and difficult for calibration (oesophageal Doppler) or invasive (arterial catheter).
The Nexfin HD allows these two measurements and it is completely non-invasive, remains to validate its use in peroperative.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Measure of the cardiac output obtained by a reference methode | Other | Device: Intraoperative heart rate measurement (reference method) |
| Measurement of cardiac output obtained by NEXFIN HD. | Other | Device: NEXFIN HD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients candidate for surgery under general anesthesia requiring oesophageal Doppler or arterial catheter hemodynamic monitoring.
Key exclusion criteria (10 listed)
- Patients with cardiac and thoracic surgery,
- patients for whom access to the head is impossible,
- facial trauma patients,
- patients with aortic malformation, dilation or coarctation,
- patients with aortic dissection,
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 |
|---|---|---|
| Intraoperative heart rate measurement (reference method)Measurement of cardiac output by both monitors: NEXFIN HD and oesophageal doppler, blood pressure measurement by the catheter and NEXFIN HD monitor, and cardiac output and blood pressure measurements after treatment administration (vasoconstrictor or filling) | Device | Measure of the cardiac output obtained by a reference methode |
| NEXFIN HD | Device | Measurement of cardiac output obtained by NEXFIN HD. |
Primary outcome
Overall survival defines as the time between the date of surgery and death or date of last news
Time frame: 6 months
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 14 Apr 2017.
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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 Intraoperative heart rate measurement (reference method) and NEXFIN HD in people with Cardiac Output and Peroperative, run by Centre Hospitalier Universitaire, Amiens 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 1 inclusion and 10 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 14 Apr 2017. 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?
Overall survival defines as the time between the date of surgery and death or date of last news (time frame: 6 months). 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 14 Apr 2017; AzTrials last refreshed its copy on 8 Nov 2026.