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

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое 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.
• Поведенческое Radial line guided hemodynamic management
  The anesthesiologist will guide their hemodynamic management on the classically used radial arterial line.
• Устройство Radial line catheterization
  An arterial line will be inserted in the radial artery of the patient.
• Устройство Brachial line catheterization
  An arterial line will be inserted in the brachial artery of the patient.

Первичные конечные точки

• Time-weighted average administration of noradrenaline [Срок оценки: Intraoperative administration]

Вторичные конечные точки (12)

• Total amount of noradrenaline administered [Срок оценки: Intraoperative administration]
• Total time of hypotension [Срок оценки: Intraoperative]
• Occurrence and depth of radial-to-brachial gradient [Срок оценки: Intraoperative]
• Dose of other inotropes and vasopressors [Срок оценки: Intraoperative administration]
• Fluid balance [Срок оценки: Intraoperative administration]
• Urine output [Срок оценки: Intraoperative]
• Total consumption of opioids [Срок оценки: Intraoperative]
• Total consumption of hypnotic drug [Срок оценки: Intraoperative]
• Cumulative duration of burst suppression and low BIS values [Срок оценки: Intraoperative]
• Troponin and Creatinine lab measurements [Срок оценки: Post-anesthesia care unit and post-operative day 1,3 and 7]
• Clavien-Dindo Score [Срок оценки: Post-operative day 1,3 and 7]
• Composite occurence of postoperative complications [Срок оценки: Post-operative day 1,3 and 7]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• Maisonneuve-Rosemont Hospital — Montreal

Публикации

• 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/ja PMID 32065827
• 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 C PMID 28973220
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT06982001 · 2023-3299

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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