Cardiac and Aortic Surgery Clinical Trial
— EPRACOfficial title:
Ultrasound Prediction of Radial Arterial Catheterization Failure in Patients Undergoing Cardiac or Aortic Surgery: a Prospective Study
| Verified date | October 2022 |
| Source | University Hospital, Montpellier |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
In patients undergoing cardiac or aortic surgery, the placement of a radial KTA is sometimes difficult, the purpose of this study is to do an ultrasound in order to evaluate the diagnostic values of the internal diameter of the radial artery to predict the failure to install the radial KTA.
| Status | Completed |
| Enrollment | 330 |
| Est. completion date | April 11, 2022 |
| Est. primary completion date | April 6, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Aged from 18 years old - Be operated for a scheduled cardiac or aortic surgery - Be able to complete all the visits and follow the study procedures - Subjects must be covered by public health insurance Exclusion Criteria: - Patients protected by law or Absence of signed informed consent - Emergency Surgery Patient - Patient already with an arterial catheter - Patient with Radial Arterial Catheter Contraindication - Radial arterial catheter placed by an anesthesiologist nurse student |
| Country | Name | City | State |
|---|---|---|---|
| France | University hospital of Montpellier | Montpellier |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Montpellier |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Failure to insert a radial artery catheter (KTA) by the nurse anesthesiologists | Failure to insert the radial KTA by the nurse anesthesiologist defined as follows: = 3 punctures (by the nurse anesthetist) or need to change of doctor operator (nurse anesthesiologist to Anesthesiologist - Resuscitator) or change of puncture site (radial to radial contralateral or other site). All professionals involved are blinded to the echographic measures of the radial artery. | Day 1 | |
| Secondary | Internal radial artery diameter | Measured on echographic exam. Image acquisition done by an independent nurse anesthesist (not involved in the management of the same patient). Radial artery diameter measured on these images, later, by an anaesthesiologist-Resuscitator physician. | Day 1 | |
| Secondary | External radial artery diameter | Measured on echographic exam. Image acquisition done by an independent nurse anesthesist (not involved in the management of the same patient). Radial artery diameter measured on these images, later, by an anaesthesiologist-Resuscitator physician. | Day 1 | |
| Secondary | Internal area of the radial artery | Measured on echographic exam. Image acquisition done by an independent nurse anesthesist (not involved in the management of the same patient). Radial artery diameter measured on these images, later, by an anaesthesiologist-Resuscitator physician. | Day 1 | |
| Secondary | External area of the radial artery | Measured on echographic exam. Image acquisition done by an independent nurse anesthesist (not involved in the management of the same patient). Radial artery diameter measured on these images, later, by an anaesthesiologist-Resuscitator physician. | Day 1 | |
| Secondary | Calcification of arterial wall (yes/no) | Measured on echographic exam. Image acquisition done by an independent nurse anesthesist (not involved in the management of the same patient). Radial artery diameter measured on these images, later, by an anaesthesiologist-Resuscitator physician. | Day 1 | |
| Secondary | Thickness of arteria wall | Measured on echographic exam. Image acquisition done by an independent nurse anesthesist (not involved in the management of the same patient). Radial artery diameter measured on these images, later, by an anaesthesiologist-Resuscitator physician. | Day 1 | |
| Secondary | Ratio between internal and external arteria diameter | Measured on echographic exam. Image acquisition done by an independent nurse anesthesist (not involved in the management of the same patient). Radial artery diameter measured on these images, later, by an anaesthesiologist-Resuscitator physician. | Day 1 | |
| Secondary | Clinical characteristics at baseline | Age, sex, body mass index, ASA score, duration of preoperative fasting, cardiovascular risk factors, cardiovascular conditions, wrist circumference, pulse force of the radial, ulnar, and brachial arteries (no pulse / feeble pulse / normal pulse), mean arterial pressure at punction time, dose of vasopressants (ephedrine, neosynephrine, noradrenaline) at punction time | Day 1 | |
| Secondary | Punction-related adverse events | Hematoma, dissection, thrombosis, ischemia, false aneuvrysm, infection, pain. | 6 months | |
| Secondary | Duration of arterial punction | delay between first pulse palpation and end of bandage on a functional catheter | Day 1 | |
| Secondary | Duration of patient management | duration of anaesthesia, duration of presence in surgery room, length of hospital stay | 28 days |