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

NCT06982001 | Not Yet Recruiting

• 1 other identifier: 2023-3299
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

Brief 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 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. 1.Does arterial pressure measurement sites influence the amount of vasopressors that is administered during major abdominal surgeries?
2. 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. 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.

Conditions

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

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

Outcome Measures

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.

  Intraoperative administration

Secondary Outcomes (12)

• Total amount of noradrenaline administered

  Intraoperative administration

• Total time of hypotension

  Intraoperative

• Occurrence and depth of radial-to-brachial gradient

  Intraoperative

• Dose of other inotropes and vasopressors

  Intraoperative administration

• Fluid balance

  Intraoperative administration

Study Arms (2)

Brachial artery-guided interventions

EXPERIMENTAL

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.

Behavioral: Brachial line guided hemodynamic management; Device: Radial line catheterization; Device: Brachial line catheterization

Radial artery-guided interventions

ACTIVE COMPARATOR

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.

Behavioral: Radial line guided hemodynamic management; Device: Radial line catheterization; Device: Brachial line catheterization

Interventions

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.

Brachial artery-guided interventions

Radial line guided hemodynamic management BEHAVIORAL

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

Radial artery-guided interventions

Radial line catheterization DEVICE

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

Brachial artery-guided interventions; Radial artery-guided interventions

Brachial line catheterization DEVICE

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

Brachial artery-guided interventions; Radial artery-guided interventions

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ciusss de L'Est de l'Île de Montréal: lead
• Fondation Anesthesiologistes du Quebec: collaborator
• Fonds de la Recherche en Santé du Québec: collaborator

Study Sites (1)

Maisonneuve-Rosemont Hospital

Montreal, Quebec, H1T2M4, Canada

Location

Related Publications (6)

• 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.

  PMID: 32065827 BACKGROUND

• 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.

  PMID: 28973220 BACKGROUND

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

  PMID: 19281442 BACKGROUND

• 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.

  PMID: 31939844 BACKGROUND

• 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.

  PMID: 30997633 BACKGROUND

• 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.

  PMID: 30928979 BACKGROUND

Central Study Contacts

Pascal Laferriere-Langlois, MD, MSc

CONTACT

+1-514-252-3400; Pascal.laferriere-langlois@umontreal.ca

Nadia Godin, BSc

CONTACT

+1-514-252-3400; ngodin.hmr@ssss.gouv.qc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: May 21, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 21, 2025

Record last verified: 2024-10

Locations

CA (1)