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Perioperative CareIPAMSNCT06982001

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

A study testing Brachial line guided hemodynamic management, Radial line guided hemodynamic management and Radial line catheterization in people with Perioperative Care and Hemodynamics, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 90 years
What is being tested?
Brachial line guided hemodynamic management, Radial line guided hemodynamic management and Radial line catheterization
Could I receive a placebo?
No, everyone receives an active treatment
How many people
204 participants
Where
1 siteCanada
Study dates
Sep 2025to Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Canada1 site
  • Maisonneuve-Rosemont Hospital

    Montreal, Quebec, H1T2M4

    Pascal Laferriere-Langlois, MD, MSc, +1-514-252-3400 ext. 3193, Pascal.laferriere-langlois@umontreal.com

    Pascal Laferriere-Langlois, MD, MSc

Other trials in Canada

About this study

Official 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

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.
Being tested
Brachial line guided hemodynamic management, Radial line guided hemodynamic management, Radial line catheterization, Brachial line catheterization
Keywords
Comparison of arterial catheterization sites on hemodynamic monitoring, Incidence of radial-brachial pressure gradient, Risk factors of radial-brachial pressure gradient, Effect of arterial catheterization sites on hemodynamic management, Effect of peripheral vs central arterial pressure measurements in intraoperative hemodynamic management

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Brachial line guided hemodynamic managementBehavioural

    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 managementBehavioural

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

  • Radial line catheterizationDevice

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

  • Brachial line catheterizationDevice

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

Study groups in NCT06982001
Study groupRoleWhat they receive
Brachial artery-guided interventionsExperimentalIn 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.
Receives: Behavioral: Brachial line guided hemodynamic management; Device: Radial line catheterization; Device: Brachial line catheterization
Radial artery-guided interventionsActive comparatorIn 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.
Receives: Behavioral: Radial line guided hemodynamic management; Device: Radial line catheterization; Device: Brachial line catheterization

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Intraoperative administration

Secondary outcomes (12)
  1. Total amount of noradrenaline administered

    Total dose of norephinephrine from skin incision to skin suture.

    Measured: 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.

    Measured: 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

    Measured: 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.

    Measured: Intraoperative administration

  5. Fluid balance

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

    Measured: Intraoperative administration

  6. Urine output

    Total and time weighted output of urine, measured every hour

    Measured: Intraoperative

  7. Total consumption of opioids

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

    Measured: Intraoperative

  8. Total consumption of hypnotic drug

    Total and time-weighted dose of hypnotic drug administered.

    Measured: Intraoperative

  9. Cumulative duration of burst suppression and low BIS values

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

    Measured: Intraoperative

  10. Troponin and Creatinine lab measurements

    Value of troponin and creatinine of the patient

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

  11. Clavien-Dindo Score

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

    Measured: Post-operative day 1,3 and 7

  12. Composite occurence of postoperative complications

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

    Measured: Post-operative day 1,3 and 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2025
  2. Study startSep 2025 (estimated)
  3. Primary completionSep 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
204 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06982001
Sponsor's protocol ID
2023-3299
Acronym
IPAMS
Status last verified
Oct 2024
First submitted
13 May 2025
Last updated
21 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: IPD might not be shared depending on the ethical consideration of sharing the information. We are currently working on a central database for perioperative research data collected at our institution, which will structure all IPD. Depending on the advancement of this initiative, we might enable IPD.

Publications

  • Wijnberge M, Geerts BF, Hol L, Lemmers N, Mulder MP, Berge P, Schenk J, Terwindt LE, Hollmann MW, Vlaar AP, Veelo DP. Effect of a Machine Learning-Derived Early Warning System for Intraoperative Hypotension vs Standard Care on Depth and Duration of Intraoperative Hypotension During Elective Noncardiac Surgery: The HYPE Randomized Clinical Trial. JAMA. 2020 Mar 17;323(11):1052-1060. doi: 10.1001/jama.2020.0592.

    PubMed 32065827
  • Futier E, Lefrant JY, Guinot PG, Godet T, Lorne E, Cuvillon P, Bertran S, Leone M, Pastene B, Piriou V, Molliex S, Albanese J, Julia JM, Tavernier B, Imhoff E, Bazin JE, Constantin JM, Pereira B, Jaber S; INPRESS Study Group. Effect of Individualized vs Standard Blood Pressure Management Strategies on Postoperative Organ Dysfunction Among High-Risk Patients Undergoing Major Surgery: A Randomized Clinical Trial. JAMA. 2017 Oct 10;318(14):1346-1357. doi: 10.1001/jama.2017.14172.

    PubMed 28973220
  • Galluccio ST, Chapman MJ, Finnis ME. Femoral-radial arterial pressure gradients in critically ill patients. Crit Care Resusc. 2009 Mar;11(1):34-8.

    PubMed 19281442
  • Ahuja S, Mascha EJ, Yang D, Maheshwari K, Cohen B, Khanna AK, Ruetzler K, Turan A, Sessler DI. Associations of Intraoperative Radial Arterial Systolic, Diastolic, Mean, and Pulse Pressures with Myocardial and Acute Kidney Injury after Noncardiac Surgery: A Retrospective Cohort Analysis. Anesthesiology. 2020 Feb;132(2):291-306. doi: 10.1097/ALN.0000000000003048.

    PubMed 31939844
  • Renaud-Roy E, Stockle PA, Maximos S, Brulotte V, Sideris L, Dube P, Drolet P, Tanoubi I, Issa R, Verdonck O, Fortier LP, Richebe P. Correlation between incremental remifentanil doses and the Nociception Level (NOL) index response after intraoperative noxious stimuli. Can J Anaesth. 2019 Sep;66(9):1049-1061. doi: 10.1007/s12630-019-01372-1. Epub 2019 Apr 17.

    PubMed 30997633
  • Tang Y, Zhu C, Liu J, Wang A, Duan K, Li B, Yuan H, Zhang H, Yao M, Ouyang W. Association of Intraoperative Hypotension with Acute Kidney Injury after Noncardiac Surgery in Patients Younger than 60 Years Old. Kidney Blood Press Res. 2019;44(2):211-221. doi: 10.1159/000498990. Epub 2019 Mar 29.

    PubMed 30928979

Questions about this trial

What is this clinical trial studying?

A study testing Brachial line guided hemodynamic management, Radial line guided hemodynamic management and Radial line catheterization in people with Perioperative Care and Hemodynamics, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Pascal Laferriere-Langlois, MD, MSc (+1-514-252-3400 ext. 3193, Pascal.laferriere-langlois@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time-weighted average administration of noradrenaline (time frame: Intraoperative administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06982001, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.

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