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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorCiusss de L'Est de l'Île de Montréal

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Brachial line guided hemodynamic management

    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 guided hemodynamic management

    Behavioral

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

  • Radial line catheterization

    Device

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

  • Brachial line catheterization

    Device

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

Treatment groups

204 Participants
are divided into 2 treatment groups
Group A: Brachial artery-guided interventionsExperimental treatment 3 interventions
Group B: Radial artery-guided interventionsActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Intraoperative administration

Secondary outcomes

1

Total amount of noradrenaline administered

Total dose of norephinephrine from skin incision to skin suture.

Time frame
Intraoperative administration
2

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.

Time frame
Intraoperative
3

Occurrence and depth of radial-to-brachial gradient

The depth-weighted time spent with a pressure gradient between the radial and brachial arterial pressures

Time frame
Intraoperative
4

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.

Time frame
Intraoperative administration

Other outcomes

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: