Arterial Measurement Sites for Hemodynamic Management

(IPAMS Trial)

Overseen By Pascal Laferriere-Langlois, MD, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ciusss de L'Est de l'Île de Montréal

Disqualifiers: Severe vascular disease, Arterial gradient, Allergies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

204 Participants Needed

Trial Summary

What is the purpose of 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

Adults scheduled for elective major abdominal surgeries who meet the study's criteria can join this trial. It aims to see if where we measure blood pressure during surgery affects how much medicine is used to keep blood pressure stable.

Inclusion Criteria

I have had major surgery in my abdomen with general anesthesia.

My surgery is expected to last more than 2 hours under anesthesia.

Exclusion Criteria

I have severe blood vessel disease in my arms.

Significant arterial gradient between arms with preoperative non-invasive blood pressure measurements (>25 mm Hg of systolic blood pressure or 10 mm Hg of mean arterial pressure)

Known allergies, intolerance, other medical conditions that preclude the use of prescribed general anesthesia protocol for this trial

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intraoperative Monitoring

Participants undergo arterial pressure monitoring using radial and brachial lines during major abdominal surgeries. Hemodynamic management is guided by either radial or brachial arterial lines depending on the group.

Duration of surgery

1 visit (in-person)

Post-operative Monitoring

Participants are monitored for post-operative complications and recovery, including fluid balance, noradrenaline administration, and other hemodynamic parameters.

7 days

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including evaluation of post-operative complications and lab measurements.

7 days

3 visits (in-person)

Treatment Details

Interventions

• Brachial line catheterization
• Brachial line guided hemodynamic management
• Radial line catheterization
• Radial line guided hemodynamic management

Trial Overview The trial tests two ways of monitoring blood pressure in surgery: using a radial artery line (usual method) or a brachial artery line (could be more accurate). Patients are randomly chosen to get one method, and doctors use that data to decide on fluid and drug management without knowing which method is being used.

Participant Groups

Group I: Brachial artery-guided interventions Experimental Treatment 3 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 II: Radial artery-guided interventions Active Control 3 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.

Who Is Running the Clinical Trial?

Ciusss de L'Est de l'Île de Montréal

Lead Sponsor

Trials

81

Recruited

6,400+

Fonds de la Recherche en Santé du Québec

Collaborator

Trials

84

Recruited

46,700+

Fondation Anesthesiologistes du Quebec

Collaborator