About this trial
The goal of this clinical trial is to demonstrate the importance of arterial pressure measurement sites during major abdominal surgeries. This randomized controlled trial will compare arterial pressure measurements obtained from radial artery catheterization (the current standard method of monitoring) with those obtained from brachial artery catheterization (a more accurate reflection of central arterial pressure). At the end of the study, we are looking to answer the following questions:
1. Does arterial pressure measurement sites influence the amount of vasopressors that is administered during major abdominal surgeries? 2. What are the instances where there is a difference between peripheral (radial catheter) and central (brachial catheter) monitoring and what are the risk factors leading to the appearance of this radial-brachial pressure gradient? 3. With the data collected, can artificial intelligence based analysis help predict the reliability of a radial monitoring and help guide clinicians on choosing a peripheral versus central arterial pressure monitoring site? All adult participants who are scheduled for elective major abdominal surgeries and meeting our inclusion criteria will be approached and included if they consent. Participants will be randomized 1:1 in the intervention group and the standard of care group. In the intervention group, the brachial arterial line will be used intraoperatively to guide vasopressor and fluid administration. A radial line will also be installed to measure the radial arterial pressure simultaneously, but will not be used to guide hemodynamic management. In the standard of care group, both lines will be installed just like in the intervention group, however, it is the radial arterial line that will guide fluid and vasopressor administration. In both groups, the anesthesia protocol will be standardized and the anesthesiologist will be blinded to the arterial pressure measurement site.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients between 18 and 90 years of age;
Major abdominal surgery via laparoscopy or laparotomy under general anesthesia - with or without concomitant use of regional or neuraxial anesthesia;
Expected anesthesia time of more than 120 minutes.
Disqualifiers
Known peripheral severe vascular disease with subclavian artery stenosis,
Significant arterial gradient between arms with preoperative non-invasive bloop pressure measurements (>25 mm Hg of systolic blood pressure or 10 mm Hg of mean arterial pressure);
Inability or contraindications to insert arterial line on either arm (arteriovenous fistula, surgical sterility);
Known allergies, intolerance, other medical conditions that precludes the use of prescribed general anesthesia protocol for this trial;
Trial design
Parallel
Treatments tested in this trial
Brachial line guided hemodynamic management
BehavioralAnesthesiologists in charge of the patients will guide their hemodynamic management based on the monitoring of brachial/humeral arterial line, instead of the most frequently used radial line.
Radial line guided hemodynamic management
BehavioralThe anesthesiologist will guide their hemodynamic management on the classically used radial arterial line.
Radial line catheterization
DeviceAn arterial line will be inserted in the radial artery of the patient.
Brachial line catheterization
DeviceAn arterial line will be inserted in the brachial artery of the patient.
Treatment groups
Trial outcomes
Primary outcomes
Time-weighted average administration of noradrenaline
The administration of norepinephrine will be continuously monitored during the surgery, and the time-weighted dose per kilograms will be extracted between the surgical incision and the last skin suture.
Secondary outcomes
Total amount of noradrenaline administered
Total dose of norephinephrine from skin incision to skin suture.
Total time of hypotension
Total time and time weighted spent below the inferior threshold (baseline MAP-20%), measured independently by the radial line and the brachial line.
Occurrence and depth of radial-to-brachial gradient
The depth-weighted time spent with a pressure gradient between the radial and brachial arterial pressures
Dose of other inotropes and vasopressors
Any administration of vasopressor or inotropes, other than the noradrenaline measured in the primary outcome. Total dose and time weighted if perfused.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Ciusss de L'Est de l'Île de Montréal
Lead sponsor
Fondation Anesthesiologistes du Quebec
Collaborator
Fonds de la Recherche en Santé du Québec
Collaborator
This trial is not recruiting at the moment. You can still explore other options: