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| Name | Class |
|---|---|
| Fondation Anesthesiologistes du Quebec | UNKNOWN |
| Fonds de la Recherche en Santé du Québec | OTHER_GOV |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Total amount of noradrenaline administered | Total dose of norephinephrine from skin incision to skin suture. | Intraoperative administration |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pascal Laferriere-Langlois, MD, MSc | Contact | +1-514-252-3400 | 3193 | Pascal.laferriere-langlois@umontreal.ca |
| Nadia Godin, BSc | Contact | +1-514-252-3400 | 3193 | ngodin.hmr@ssss.gouv.qc.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maisonneuve-Rosemont Hospital | Montreal | Quebec | H1T2M4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32065827 | Background | 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. | |
| 28973220 |
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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.
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| Radial line guided hemodynamic management | Behavioral | The anesthesiologist will guide their hemodynamic management on the classically used radial arterial line. |
|
| Radial line catheterization | Device | An arterial line will be inserted in the radial artery of the patient. |
|
| Brachial line catheterization | Device | An arterial line will be inserted in the brachial artery of the patient. |
|
| Intraoperative |
| Occurrence and depth of radial-to-brachial gradient | The depth-weighted time spent with a pressure gradient between the radial and brachial arterial pressures | Intraoperative |
| 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. | Intraoperative administration |
| Fluid balance | Total and time weighted fluid administered intraoperatively (volume and nature) | Intraoperative administration |
| Urine output | Total and time weighted output of urine, measured every hour | Intraoperative |
| Total consumption of opioids | Total and time weighted dose of opioids (remifentanil) administered intraoperatively | Intraoperative |
| Total consumption of hypnotic drug | Total and time-weighted dose of hypnotic drug administered. | Intraoperative |
| 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). | Intraoperative |
| Troponin and Creatinine lab measurements | Value of troponin and creatinine of the patient | Post-anesthesia care unit and post-operative day 1,3 and 7 |
| Clavien-Dindo Score | A validated score evaluating the occurence of post-operative complications. | Post-operative day 1,3 and 7 |
| Composite occurence of postoperative complications | Composite outcome comprising the occurrence of myocardial injury after non-cardiac surgery (MINS), stroke, arrythmia, and death. | Post-operative day 1,3 and 7 |
| 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. |
| 19281442 | 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. |
| 31939844 | 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. |
| 30997633 | 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. |
| 30928979 | 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. |