Trials / Not Yet Recruiting
Not Yet RecruitingNCT06982001
ImPortance of Arterial Measurement Sites (IPAMS) on Intraoperative Hemodynamic Management
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
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 204 (estimated)
- Sponsor
- Ciusss de L'Est de l'Île de Montréal · Academic / Other
- Sex
- All
- Age
- 18 Years – 90 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Perioperative Care
- Hemodynamics
- Monitoring Blood Pressure
- Arterial Lines
- Anesthesia
- Vasopressor
- Fluid Management
- Artificial Intelligence in Operating Room
- Artificial Intelligence (AI)
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Brachial line guided hemodynamic management | 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. |
| BEHAVIORAL | Radial line guided hemodynamic management | The anesthesiologist will guide their hemodynamic management on the classically used radial arterial line. |
| DEVICE | Radial line catheterization | An arterial line will be inserted in the radial artery of the patient. |
| DEVICE | Brachial line catheterization | An arterial line will be inserted in the brachial artery of the patient. |
Timeline
- Start date
- 2025-09-01
- Primary completion
- 2028-09-01
- Completion
- 2028-12-01
- First posted
- 2025-05-21
- Last updated
- 2025-05-21
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT06982001. Inclusion in this directory is not an endorsement.