Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05654402 |
| Other study ID # |
APHP2203812 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 10, 2023 |
| Est. completion date |
August 2024 |
Study information
| Verified date |
March 2023 |
| Source |
Assistance Publique - Hôpitaux de Paris |
| Contact |
Joaquim MD MATEO |
| Phone |
+33 (0)149958374 |
| Email |
joaquim.mateo[@]aphp.fr |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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.
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
