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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

204 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2028-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Brachial artery-guided interventions

In this experimental group, hemodynamic management will be guided by using the brachial arterial line. Both a radial and a brachial line will be inserted for simultaneous monitoring, but the anesthesiologist will only see the brachial arterial line and will guide his drug administration and hemodynamic management on the brachial measurements.

Group Type EXPERIMENTAL

Brachial line guided hemodynamic management

Intervention Type BEHAVIORAL

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.

Radial line catheterization

Intervention Type DEVICE

An arterial line will be inserted in the radial artery of the patient.

Brachial line catheterization

Intervention Type DEVICE

An arterial line will be inserted in the brachial artery of the patient.

Radial artery-guided interventions

In this group, hemodynamic management will be guided by using the radial arterial line. Both a radial and a brachial line will be inserted for simultaneous monitoring, but the anesthesiologist will only see the radial arterial line and will guide his drug administration and hemodynamic management on the brachial measurements.

Group Type ACTIVE_COMPARATOR

Radial line guided hemodynamic management

Intervention Type BEHAVIORAL

The anesthesiologist will guide their hemodynamic management on the classically used radial arterial line.

Radial line catheterization

Intervention Type DEVICE

An arterial line will be inserted in the radial artery of the patient.

Brachial line catheterization

Intervention Type DEVICE

An arterial line will be inserted in the brachial artery of the patient.

Interventions

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Brachial 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.

Intervention Type BEHAVIORAL

Radial line guided hemodynamic management

The anesthesiologist will guide their hemodynamic management on the classically used radial arterial line.

Intervention Type BEHAVIORAL

Radial line catheterization

An arterial line will be inserted in the radial artery of the patient.

Intervention Type DEVICE

Brachial line catheterization

An arterial line will be inserted in the brachial artery of the patient.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No