Anesthesia, LocalNIVOPNCT05654402
Non-invasive Measurement of Arterial Stiffness
An observational study of Anesthesia, Local and Anesthesia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Reducing the risk of perioperative cardiovascular complications is a major issue for anesthesiology practice and research. Carotid-Femoral Pulse Wave Velocity (PWVcf)is a predictive, early and independent biomarker of cardiovascular events. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Local, Anesthesia
- What is being tested?
- Non-invasive measurement of carotid-femoral transit time by Doppler velocimetry (Athys Medical©) - WAKIe R3 2TC®) (PWV in cm/s)
- How many people
- 98 participants
- Where
- 1 siteFrance
- Study dates
- 10 Feb 2023to Aug 2024
- Phase
- Observational
- 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
Study population: Participants or populations are selected based on predefined criteria.
Who may be able to join
- Patients of legal age ( 18 years)
- Eligible for a scheduled surgical procedure under general or locoregional anesthesia.
- Patients who have expressed no objection to participating in this research
Who cannot join
- Patients under 18 years of age.
- Carotid or femoral space not available
- Atrial fibrillation arrhythmia (AFA)
- Advanced obliterative arteriopathy of the lower limbs (grade III and IV - Leriche and Fontaine)
- Patient opposed to participation in the protocol
- Pregnant woman
- Patient under judicial protection
- Patient not affiliated to a social health system
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
AP-HP, Lariboisière Hospital, Department of Anesthesiology and Intensive Care
Paris, 75010
Joaquim MATEO, MD, 1 49 95 83 74 ext. +33, joaquim.mateo@aphp.fr
Fabrice VALLEE, MD, PhD, 1 49 95 80 71 ext. +33, vallee.fabrice@gmail.com
About this study
Official title: Non-invasive Measurement of Arterial Stiffness by Pulse Wave Velocity.
Reducing the risk of perioperative cardiovascular complications is a major issue for anesthesiology practice and research. Carotid-Femoral Pulse Wave Velocity (PWVcf)is a predictive, early and independent biomarker of cardiovascular events. Despite the unanimous support for PWVcf, it has not been widely used in routine clinical practice because of the complexity of the measurement method. Our team has developed a method to estimate PWVcf continuously in the operating room from the data obtained by the usual monitoring: an electrocardiogram (ECG), a digital photoplethysmography (PPG) and an oscillometric brachial sphygmomanometer for non-invasive blood pressure measurement (NIP). The objective of this study is to validate, during anesthesia, the method of estimation of PWV (obtained using the usual monitoring tools including the parameters derived from the SpO2 signal, NIBP and ECG) by comparing it to the reference method by measuring the carotid-femoral transit time obtained by Doppler effect. The measurement of the carotid-femoral transit time obtained by Doppler effect is totally non-invasive.
Read the detailed description
Reducing the risk of perioperative cardiovascular complications is a major issue for anesthesiology practice and research. The risk of postoperative cardiovascular complications could therefore be stratified by screening "rigid" patients who have no cardiovascular risk factors.
Assessment of large-caliber artery stiffness is a predictive, early, and independent biomarker of cardiovascular events, currently included in European guidelines for the management of hypertension. It is also a physiological parameter that reflects left ventricular afterload and is very useful during the management of patients under general anesthesia. The parameter considered as the "gold standard" for the evaluation of this arterial stiffness is the measurement of the pulse wave velocity (PWV) or carotid-femoral pulse wave velocity (PWVcf). PWVcf is the propagation speed of the pulse wave from the carotid artery to the femoral artery, i.e., the time it takes for the pulse wave to travel from a point in the carotid artery to a point in the femoral artery. PWVcf has not become widespread in routine clinical practice because of the complexity of the measurement method. Indeed, PWVcf measurement can only be performed by imaging (MRI), or by ultrasound technique (combined carotid and femoral Doppler) or by combined tonometry (e.g. SphygmoCor, Complior). These techniques require specific equipment as well as training, expertise and learning of the collection technique. Previous studies have allowed the development of an algorithm allowing indirect measurement of PWV from combined carotid-femoral Doppler and tonometry PWVcf measurements in patients under general anesthesia. Thanks to the acquisition tools, the data will be available and of high quality, guaranteeing that the tools/algorithm developed from them will not be biased and will be more efficient.
The objective of this study is to validate, during anesthesia, the method of estimation of PWV (obtained using the usual monitoring tools including the parameters derived from the SpO2 signal, NIBP and ECG) by comparing it to the reference method by measuring the carotid-femoral transit time obtained by Doppler effect.
Patients over 18 years old are eligible to participate in this protocol. During the anaesthesia consultation, patients will be given a letter of information on the objectives and progress of the study. Their non-objection to participate in this study will be collected at the latest during the pre-anesthetic visit, the day before the operation, after a period of reflection.
The protocol will start on the day of the operation. The procedures will be performed under general anesthesia or locoregional anesthesia. The protocol does not interact with the care procedure.
The 2 self-adhesive Doppler sensors are placed at the level of the common carotid and superficial femoral arteries at the level of the Scarpa. The visualized signal is automatically validated after several cycles when the quality is satisfactory (Athys Medical©) - WAKIe R3 2TC®). This signal, allowing the measurement of the carotid-femoral transit time, is then recorded on Data Warehouse Connect.
The distance between the two measurement points is measured with a tape measure. Knowing the carotid-femoral transit time, the propagation speed of the wave (expressed in m/s) can be calculated.
No invasive devices are used in addition to those required for anesthesia. All the monitoring instruments described above, except the one studied, are already used routinely in our department. The duration of anesthesia is not prolonged for the study. The Doppler is performed during the awake, anesthetic induction and awake phase.
No additional exams will be performed. The anesthetic strategy is decided by the anesthesiologist in charge of the operation.
The physician in charge of the study collecting the data does not participate at any time in the management of the patient. The measures cannot influence the prescribing physician since at this stage the data are not yet analyzed and available
The estimation of the number of subjects to be included is based on the primary endpoint, namely the intraclass correlation coefficient. Thus, to demonstrate an ICC of 0.9 with a confidence interval of 0.1, for a 5% alpha risk, it is necessary to include 98 patients.
Continuous data are expressed as median [interquartile] and categorical data as n (%). Categorical variables will be compared by Mann-Whtney test and continuous variables by Wilcoxon test.
The agreement between the two methods will be evaluated by the intra-class correlation coefficient as well as by the Bland-Altman representation (with determination of the bias and the limits of agreement), for the different parameters of interest. All statistical analyses will be performed using R statistical software (The 'R' Foundation for Statistical Computing, Vienna, Austria). The results will be expressed as means (± standard deviation). A p-value less than 0.05 is considered significant
- Conditions
- Anesthesia, Local, Anesthesia
- Being tested
- Non-invasive measurement of carotid-femoral transit time by Doppler velocimetry (Athys Medical©) - WAKIe R3 2TC®) (PWV in cm/s)
- Keywords
- Predictive medicine, Pulse wave velocity, Cardiovascular complications, Predictive Biomarker, Arterial stiffness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive measurement of carotid-femoral transit time by Doppler velocimetry (Athys Medical©) - WAKIe R3 2TC®) (PWV in cm/s)Diagnostic test
- Measurement of the carotid-femoral transit time (ms) (recorded on Data Warehouse Connect).
- Measurement of the distance between the carotid and femoral points with a tape measure (m).
- Calculation of the propagation speed of the wave PWV (expressed in m/s).
For all patients PWV in (m/s=) will be collected over three distinct periods:
- Before induction (awake without premedication)
- During general anesthesia or loco-regional anesthesia
- Upon awakening from general anesthesia or lifting of the loco-regional anaesthesia
What is being measured
The primary outcome is the main question the study is designed to answer.
To study the concordance of carotid-femoral pulse wave velocity (PWVcf) values obtained by carotid-femoral Doppler method with those obtained completely noninvasively by continuous PWV estimation under the same conditions during anesthesia.
Non-invasive measurement of carotid-femoral transit time by Doppler velocimetry (PWV in cm/s).
Measured: 1 day
Study concordance of carotid-femoral pulse wave velocity values obtained by carotid-femoral Doppler method and those obtained completely noninvasively by continuous PWV estimation under the same conditions during anesthesia using mean arterial pressure
Non-invasive continuous measurement of mean arterial pressure in mmHg.
Measured: 1 day
To study the concordance of carotid-femoral pulse wave velocity values obtained by carotid-femoral Doppler method with those obtained completely noninvasively by continuous PWV estimation under the same conditions during anesthesia using blood pressure.
Discontinuous measurement of blood pressure with an oscillometric brachial blood pressure monitor.
Measured: 1 day
To study the concordance of carotid-femoral pulse wave velocity (PWVcf) values obtained by carotid-femoral Doppler method with those obtained completely noninvasively by continuous PWV estimation under the same conditions during anesthesia using ECG.
Continuous ECG recording.
Measured: 1 day
Study concordance of carotid-femoral pulse wave velocity values obtained by carotid-femoral Doppler method and those obtained by continuous PWV estimation under the same conditions during anesthesia thanks to digital photoplethysmography recording
Continuous digital photoplethysmography recording exprimed in %.
Measured: 1 day
Study concordance of carotid-femoral pulse wave velocity values obtained by carotid-femoral Doppler method and those obtained completely noninvasively by continuous PWV estimation under the same conditions during anesthesia thanks to administred agents
Quantification of delivered doses of hypnotics, morphinics and paralytic agents.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start10 Feb 2023
- Primary completionFeb 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, LocalStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- INSERM UMR-942, Paris, France, M3DISIM
- Responsible party
- Sponsor
- Investigators
- Joaquim MD MATEO, Study director, Assistance Publique - Hôpitaux de ParisFabrice MD VALLEE, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris, Department of Anesthesiology and Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05654402
- Sponsor's protocol ID
- APHP2203812
- Acronym
- NIVOP
- Status last verified
- Mar 2023
- First submitted
- 21 Nov 2022
- Last updated
- 6 Mar 2023
- 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 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Measurement of Arterial Stiffness by Pulse Wave Velocity.
- ClinicalTrials.gov ID
- NCT05654402
- Acronym / sponsor ID
- NIVOP / APHP2203812
- Conditions
- Anesthesia, Local, Anesthesia
- Keywords
- Predictive medicine, Pulse wave velocity, Cardiovascular complications, Predictive Biomarker, Arterial stiffness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- INSERM UMR-942, Paris, France, M3DISIM
- Study start
- 10 Feb 2023 (actual)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 16 Dec 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.
Reducing the risk of perioperative cardiovascular complications is a major issue for anesthesiology practice and research. Carotid-Femoral Pulse Wave Velocity (PWVcf)is a predictive, early and independent biomarker of cardiovascular events. Despite the unanimous support for PWVcf, it has not been widely used in routine clinical practice because of the complexity of the measurement method. Our team has developed a method to estimate PWVcf continuously in the operating room from the data obtained by the usual monitoring: an electrocardiogram (ECG), a digital photoplethysmography (PPG) and an oscillometric brachial sphygmomanometer for non-invasive blood pressure measurement (NIP). The objective of this study is to validate, during anesthesia, the method of estimation of PWV (obtained using the usual monitoring tools including the parameters derived from the SpO2 signal, NIBP and ECG) by comparing it to the reference method by measuring the carotid-femoral transit time obtained by Doppler effect. The measurement of the carotid-femoral transit time obtained by Doppler effect is totally non-invasive.
Detailed description
Reducing the risk of perioperative cardiovascular complications is a major issue for anesthesiology practice and research. The risk of postoperative cardiovascular complications could therefore be stratified by screening "rigid" patients who have no cardiovascular risk factors.
Assessment of large-caliber artery stiffness is a predictive, early, and independent biomarker of cardiovascular events, currently included in European guidelines for the management of hypertension. It is also a physiological parameter that reflects left ventricular afterload and is very useful during the management of patients under general anesthesia. The parameter considered as the "gold standard" for the evaluation of this arterial stiffness is the measurement of the pulse wave velocity (PWV) or carotid-femoral pulse wave velocity (PWVcf). PWVcf is the propagation speed of the pulse wave from the carotid artery to the femoral artery, i.e., the time it takes for the pulse wave to travel from a point in the carotid artery to a point in the femoral artery. PWVcf has not become widespread in routine clinical practice because of the complexity of the measurement method. Indeed, PWVcf measurement can only be performed by imaging (MRI), or by ultrasound technique (combined carotid and femoral Doppler) or by combined tonometry (e.g. SphygmoCor, Complior). These techniques require specific equipment as well as training, expertise and learning of the collection technique. Previous studies have allowed the development of an algorithm allowing indirect measurement of PWV from combined carotid-femoral Doppler and tonometry PWVcf measurements in patients under general anesthesia. Thanks to the acquisition tools, the data will be available and of high quality, guaranteeing that the tools/algorithm developed from them will not be biased and will be more efficient.
The objective of this study is to validate, during anesthesia, the method of estimation of PWV (obtained using the usual monitoring tools including the parameters derived from the SpO2 signal, NIBP and ECG) by comparing it to the reference method by measuring the carotid-femoral transit time obtained by Doppler effect.
Patients over 18 years old are eligible to participate in this protocol. During the anaesthesia consultation, patients will be given a letter of information on the objectives and progress of the study. Their non-objection to participate in this study will be collected at the latest during the pre-anesthetic visit, the day before the operation, after a period of reflection.
The protocol will start on the day of the operation. The procedures will be performed under general anesthesia or locoregional anesthesia. The protocol does not interact with the care procedure.
The 2 self-adhesive Doppler sensors are placed at the level of the common carotid and superficial femoral arteries at the level of the Scarpa. The visualized signal is automatically validated after several cycles when the quality is satisfactory (Athys Medical©) - WAKIe R3 2TC®). This signal, allowing the measurement of the carotid-femoral transit time, is then recorded on Data Warehouse Connect.
The distance between the two measurement points is measured with a tape measure. Knowing the carotid-femoral transit time, the propagation speed of the wave (expressed in m/s) can be calculated.
No invasive devices are used in addition to those required for anesthesia. All the monitoring instruments described above, except the one studied, are already used routinely in our department. The duration of anesthesia is not prolonged for the study. The Doppler is performed during the awake, anesthetic induction and awake phase.
No additional exams will be performed. The anesthetic strategy is decided by the anesthesiologist in charge of the operation.
The physician in charge of the study collecting the data does not participate at any time in the management of the patient. The measures cannot influence the prescribing physician since at this stage the data are not yet analyzed and available
The estimation of the number of subjects to be included is based on the primary endpoint, namely the intraclass correlation coefficient. Thus, to demonstrate an ICC of 0.9 with a confidence interval of 0.1, for a 5% alpha risk, it is necessary to include 98 patients.
Continuous data are expressed as median [interquartile] and categorical data as n (%). Categorical variables will be compared by Mann-Whtney test and continuous variables by Wilcoxon test.
The agreement between the two methods will be evaluated by the intra-class correlation coefficient as well as by the Bland-Altman representation (with determination of the bias and the limits of agreement), for the different parameters of interest. All statistical analyses will be performed using R statistical software (The 'R' Foundation for Statistical Computing, Vienna, Austria). The results will be expressed as means (± standard deviation). A p-value less than 0.05 is considered significant
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants or populations are selected based on predefined criteria.
Key inclusion criteria (3 listed)
- Patients of legal age ( 18 years)
- Eligible for a scheduled surgical procedure under general or locoregional anesthesia.
- Patients who have expressed no objection to participating in this research
Key exclusion criteria (8 listed)
- Patients under 18 years of age.
- Carotid or femoral space not available
- Atrial fibrillation arrhythmia (AFA)
- Advanced obliterative arteriopathy of the lower limbs (grade III and IV - Leriche and Fontaine)
- Patient opposed to participation in the protocol
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 |
|---|---|---|
| Non-invasive measurement of carotid-femoral transit time by Doppler velocimetry (Athys Medical©) - WAKIe R3 2TC®) (PWV in cm/s)* Measurement of the carotid-femoral transit time (ms) (recorded on Data Warehouse Connect). * Measurement of the distance between the carotid and femoral points with a tape measure (m). * Calculation of the propagation speed of the wave PWV (expressed in m/s). For all patients PWV in (m/s=) will be collected over three distinct periods: * Before induction (awake without premedication) * During general anesthesia or loco-regional anesthesia * Upon awakening from general anesthesia or lifting of the loco-regional anaesthesia | Diagnostic test | – |
Primary outcome
To study the concordance of carotid-femoral pulse wave velocity (PWVcf) values obtained by carotid-femoral Doppler method with those obtained completely noninvasively by continuous PWV estimation under the same conditions during anesthesia.
Time frame: 1 day
Non-invasive measurement of carotid-femoral transit time by Doppler velocimetry (PWV in cm/s).
Study concordance of carotid-femoral pulse wave velocity values obtained by carotid-femoral Doppler method and those obtained completely noninvasively by continuous PWV estimation under the same conditions during anesthesia using mean arterial pressure
Time frame: 1 day
Non-invasive continuous measurement of mean arterial pressure in mmHg.
To study the concordance of carotid-femoral pulse wave velocity values obtained by carotid-femoral Doppler method with those obtained completely noninvasively by continuous PWV estimation under the same conditions during anesthesia using blood pressure.
Time frame: 1 day
Discontinuous measurement of blood pressure with an oscillometric brachial blood pressure monitor.
To study the concordance of carotid-femoral pulse wave velocity (PWVcf) values obtained by carotid-femoral Doppler method with those obtained completely noninvasively by continuous PWV estimation under the same conditions during anesthesia using ECG.
Time frame: 1 day
Continuous ECG recording.
Study concordance of carotid-femoral pulse wave velocity values obtained by carotid-femoral Doppler method and those obtained by continuous PWV estimation under the same conditions during anesthesia thanks to digital photoplethysmography recording
Time frame: 1 day
Continuous digital photoplethysmography recording exprimed in %.
Study concordance of carotid-femoral pulse wave velocity values obtained by carotid-femoral Doppler method and those obtained completely noninvasively by continuous PWV estimation under the same conditions during anesthesia thanks to administred agents
Time frame: 1 day
Quantification of delivered doses of hypnotics, morphinics and paralytic agents.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
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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.
Joaquim MD MATEO study director
Assistance Publique - Hôpitaux de Paris
Fabrice MD VALLEE, PhD principal investigator
Assistance Publique - Hôpitaux de Paris, Department of Anesthesiology and Intensive Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, Local and Anesthesia, run by Assistance Publique - Hôpitaux de Paris 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 3 inclusion and 8 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 6 Mar 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joaquim MD MATEO (+33 (0)149958374, joaquim.mateo@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To study the concordance of carotid-femoral pulse wave velocity (PWVcf) values obtained by carotid-femoral Doppler method with those obtained completely noninvasively by continuous PWV estimation under the same conditions during anesthesia. (time frame: 1 day). The study lists 6 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 6 Mar 2023; AzTrials last refreshed its copy on 7 Nov 2026.