Maisonneuve-Rosemont Hospital
Montreal, Quebec, H1T2M4, Canada
Location contact
Pascal Laferriere-Langlois, MD, MSc
CONTACT
+1-514-252-3400 ext. 3193
Pascal Laferriere-Langlois, MD, MSc
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06982001
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.
Trial opening soon.
Get Notified18 year–90 year
All sexes
Interventional
Not applicable
Montreal, Quebec, H1T2M4, Canada
Pascal Laferriere-Langlois, MD, MSc
CONTACT
+1-514-252-3400 ext. 3193
Pascal Laferriere-Langlois, MD, MSc
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
The anesthesiologist will guide their hemodynamic management on the classically used radial arterial line.
An arterial line will be inserted in the radial artery of the patient.
An arterial line will be inserted in the brachial artery of the patient.
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.
Time frame: Intraoperative administration
Total dose of norephinephrine from skin incision to skin suture.
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.
Time frame: Intraoperative
The depth-weighted time spent with a pressure gradient between the radial and brachial arterial pressures
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.
Time frame: Intraoperative administration
Total and time weighted fluid administered intraoperatively (volume and nature)
Time frame: Intraoperative
Total and time weighted output of urine, measured every hour
Time frame: Intraoperative
Total and time weighted dose of opioids (remifentanil) administered intraoperatively
Time frame: Intraoperative
Total and time-weighted dose of hypnotic drug administered.
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).
Time frame: Post-anesthesia care unit and post-operative day 1,3 and 7
Value of troponin and creatinine of the patient
Time frame: Post-operative day 1,3 and 7
A validated score evaluating the occurence of post-operative 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.
Contact information is provided by the study sponsor or research team.
Nadia Godin, BSc
CONTACT
+1-514-252-3400 ext. 3193
Pascal Laferriere-Langlois, MD, MSc
CONTACT
+1-514-252-3400 ext. 3193
Ciusss de L'Est de l'Île de Montréal
Other
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
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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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