Anesthesia, Arterial Lines, Artificial Intelligence (AI), Artificial Intelligence in Operating Room, Fluid Management, Hemodynamics, Monitoring Blood Pressure, Perioperative Care, Vasopressor
Conditions
Keywords
Comparison of arterial catheterization sites on hemodynamic monitoring, Incidence of radial-brachial pressure gradient, Risk factors of radial-brachial pressure gradient, Effect of arterial catheterization sites on hemodynamic management, Effect of peripheral vs central arterial pressure measurements in intraoperative hemodynamic management
Brief summary
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.
Interventions
BEHAVIORALBrachial line guided hemodynamic management
Anesthesiologists 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.
BEHAVIORALRadial line guided hemodynamic management
The anesthesiologist will guide their hemodynamic management on the classically used radial arterial line.
DEVICERadial line catheterization
An arterial line will be inserted in the radial artery of the patient.
DEVICEBrachial line catheterization
An arterial line will be inserted in the brachial artery of the patient.
Sponsors
Fondation Anesthesiologistes du Quebec
Fonds de la Recherche en Santé du Québec
Ciusss de L'Est de l'Île de Montréal
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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; * Inability to communicate in French or English.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time-weighted average administration of noradrenaline | Intraoperative administration | 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
| Measure | Time frame | Description |
|---|---|---|
| Total time of hypotension | Intraoperative | 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 | Intraoperative | The depth-weighted time spent with a pressure gradient between the radial and brachial arterial pressures |
| Dose of other inotropes and vasopressors | Intraoperative administration | Any administration of vasopressor or inotropes, other than the noradrenaline measured in the primary outcome. Total dose and time weighted if perfused. |
| Fluid balance | Intraoperative administration | Total and time weighted fluid administered intraoperatively (volume and nature) |
| Urine output | Intraoperative | Total and time weighted output of urine, measured every hour |
| Total amount of noradrenaline administered | Intraoperative administration | Total dose of norephinephrine from skin incision to skin suture. |
| Total consumption of hypnotic drug | Intraoperative | Total and time-weighted dose of hypnotic drug administered. |
| Cumulative duration of burst suppression and low BIS values | Intraoperative | Total, time weighted and importance weighted duration of BIS value below 40, and total and time-weighted duration of burst suppression (suppression time). |
| Troponin and Creatinine lab measurements | Post-anesthesia care unit and post-operative day 1,3 and 7 | Value of troponin and creatinine of the patient |
| Clavien-Dindo Score | Post-operative day 1,3 and 7 | A validated score evaluating the occurence of post-operative complications. |
| Composite occurence of postoperative complications | Post-operative day 1,3 and 7 | Composite outcome comprising the occurrence of myocardial injury after non-cardiac surgery (MINS), stroke, arrythmia, and death. |
| Total consumption of opioids | Intraoperative | Total and time weighted dose of opioids (remifentanil) administered intraoperatively |
Countries
Canada
Contacts
Primary ContactPascal Laferriere-Langlois, MD, MSc
Backup ContactNadia Godin, BSc
Outcome results
None listed