Clinical trial NCT06982001: ImPortance of Arterial Measurement Sites (IPAMS) on Intraoperative Hemodynamic Management
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: Ciusss de L'Est de l'Île de Montréal
Sponsor class: OTHER
Collaborators: name: Fondation Anesthesiologistes du Quebec
name: Fonds de la Recherche en Santé du Québec
First posted: 2025-05-21
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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: 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.

Primary outcomes:
measure: Time-weighted average administration of noradrenaline
timeFrame: Intraoperative administration
Secondary outcomes:
measure: Total amount of noradrenaline administered
timeFrame: Intraoperative administration
measure: Total time of hypotension
timeFrame: Intraoperative
measure: Occurrence and depth of radial-to-brachial gradient
timeFrame: Intraoperative
measure: Dose of other inotropes and vasopressors
timeFrame: Intraoperative administration
measure: Fluid balance
timeFrame: Intraoperative administration
measure: Urine output
timeFrame: Intraoperative
measure: Total consumption of opioids
timeFrame: Intraoperative
measure: Total consumption of hypnotic drug
timeFrame: Intraoperative
measure: Cumulative duration of burst suppression and low BIS values
timeFrame: Intraoperative
measure: Troponin and Creatinine lab measurements
timeFrame: Post-anesthesia care unit and post-operative day 1,3 and 7
measure: Clavien-Dindo Score
timeFrame: Post-operative day 1,3 and 7
measure: Composite occurence of postoperative complications
timeFrame: Post-operative day 1,3 and 7
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Maisonneuve-Rosemont Hospital
state: Quebec
Study officials:
References:
citation: 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.
citation: 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.
citation: Galluccio ST, Chapman MJ, Finnis ME. Femoral-radial arterial pressure gradients in critically ill patients. Crit Care Resusc. 2009 Mar;11(1):34-8.
citation: 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.
citation: 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.
citation: 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.