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NCT Number: NCT06982001

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

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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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maisonneuve-Rosemont Hospital

Montreal, Quebec, H1T2M4, Canada

Location contact

Pascal Laferriere-Langlois, MD, MSc

CONTACT

[email protected]

+1-514-252-3400 ext. 3193

Pascal Laferriere-Langlois, MD, MSc

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Time-weighted average administration of noradrenaline

    Time frame: 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 outcomes

  1. Total amount of noradrenaline administered

    Time frame: Intraoperative administration

    Total dose of norephinephrine from skin incision to skin suture.

  2. Total time of hypotension

    Time frame: Intraoperative

    Total time and time weighted spent below the inferior threshold (baseline MAP-20%), measured independently by the radial line and the brachial line.

  3. Occurrence and depth of radial-to-brachial gradient

    Time frame: Intraoperative

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

  4. Dose of other inotropes and vasopressors

    Time frame: Intraoperative administration

    Any administration of vasopressor or inotropes, other than the noradrenaline measured in the primary outcome. Total dose and time weighted if perfused.

  5. Fluid balance

    Time frame: Intraoperative administration

    Total and time weighted fluid administered intraoperatively (volume and nature)

  6. Urine output

    Time frame: Intraoperative

    Total and time weighted output of urine, measured every hour

  7. Total consumption of opioids

    Time frame: Intraoperative

    Total and time weighted dose of opioids (remifentanil) administered intraoperatively

  8. Total consumption of hypnotic drug

    Time frame: Intraoperative

    Total and time-weighted dose of hypnotic drug administered.

  9. Cumulative duration of burst suppression and low BIS values

    Time frame: Intraoperative

    Total, time weighted and importance weighted duration of BIS value below 40, and total and time-weighted duration of burst suppression (suppression time).

  10. Troponin and Creatinine lab measurements

    Time frame: Post-anesthesia care unit and post-operative day 1,3 and 7

    Value of troponin and creatinine of the patient

  11. Clavien-Dindo Score

    Time frame: Post-operative day 1,3 and 7

    A validated score evaluating the occurence of post-operative complications.

  12. Composite occurence of postoperative complications

    Time frame: Post-operative day 1,3 and 7

    Composite outcome comprising the occurrence of myocardial injury after non-cardiac surgery (MINS), stroke, arrythmia, and death.

Study contacts

Contact information is provided by the study sponsor or research team.

Nadia Godin, BSc

CONTACT

[email protected]

+1-514-252-3400 ext. 3193

Pascal Laferriere-Langlois, MD, MSc

CONTACT

[email protected]

+1-514-252-3400 ext. 3193

Sponsors and collaborators

Lead sponsor

Ciusss de L'Est de l'Île de Montréal

Other

Collaborators

  • Fondation Anesthesiologistes du Quebec
  • Fonds de la Recherche en Santé du Québec

Registry information

Official study title

Importance of Arterial Measurement Sites on Intraoperative Hemodynamic Management of Major Abdominal Surgeries and Artificial Intelligence-based Prediction of Arterial Gradient Using Peripheral Radial Pressure Waveform Analysis

Acronym: IPAMS

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
May 21, 2025
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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