ImPortance of Arterial Measurement Sites (IPAMS) on Intraoperative Hemodynamic Management

Not Applicable

Not yet recruiting

• Conditions: Perioperative Care; Hemodynamics; Monitoring Blood Pressure; Arterial Lines; Artificial Intelligence (AI); Anesthesia; Vasopressor; Artificial Intelligence in Operating Room; Fluid Management

• Registration Number: NCT06982001
• Lead Sponsor: Ciusss de L'Est de l'Île de Montréal

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2025-05-13
• Study First Submitted QC: 2025-05-13
• Last Update Submitted: 2025-05-13
• Study First Posted: 2025-05-21
• Last Update Posted: 2025-05-21
• Study Start: 2025-09
• Primary Completion: 2028-09
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 204

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Total amount of noradrenaline administered	Intraoperative administration	Total dose of norephinephrine from skin incision to skin suture.
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 consumption of opioids	Intraoperative	Total and time weighted dose of opioids (remifentanil) administered intraoperatively
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.

Trial Locations

Locations (1)

Maisonneuve-Rosemont Hospital; 🇨🇦 Montreal, Quebec, Canada