Pressure Recording Analytical Method Parameters and Their Relationship With Hypotension in Hypertensive Patients

Официальное название

Observational Study to Evaluate the Pressure Recording Analytical Method Parameters in Patients Susceptible to Post-induction Hypotension Due to Hypertension, Diabetes Mellitus, Cardiovascular Risk Factors, or Major Surgery

Обзор

Perioperative anesthesiologists can benefit from easily obtainable hemodynamic variables detecting or quantifying the lack of an adequate compensatory capacity of the cardiovascular system in order to optimize patient management and improve patient outcomes. Parameters of the Pressure Recording Analytical Method (PRAM; Vygon, Padua, Italy) of the MostCare system, specifically cardiac cycle efficiency has been proposed as such variables. Yet, their value in anesthesia and especially in hypertensive patients is not studied. The goal of the PRAM-in-HYPO study is to prospectively evaluate the relationship between cardiac reserve and efficiency and cardiovascular risk factors in patients wo will undergo major surgical procedures using the state-of-the-art hemodynamic monitors. Also the investigators aim to build a predictive model to identify patients with decreased cardiac reserve due to hypertension and other cardiovascular risk factors, who are susceptible to post-induction hypotension. The investigators seek to include high-risk patients or patients presenting for major surgery, who are monitored with an advanced hemodynamic monitor to adequately evaluate the differences in cardiac reserve and cardiac efficiency.

Подробное описание

Untreated hypertension decreases the cardiac reserve through several mechanisms, which are augmented by other cardiovascular risk factors such as diabetes mellitus and coronary artery disease. Perioperative stress on top of these overlapping diseases causes wide variations in the arterial blood pressure. From the anesthesiologist's point of view, this translates into a wide variation in response to surgical stress among patients with seemingly similar cardiovascular risk factors.

The cardiac reserve may be measured by cardiac catheterization or echocardiography, none of which are feasible during a surgery. Recently, some parameters of the Pressure Recording Analytical Method (PRAM) were shown to be affected by hypertension or intraoperative events such as pneumoperitoneum and position changes. This suggests that PRAM may be used to evaluate the risk of adverse hemodynamic events in newly diagnosed, untreated hypertensive patients.

The investigators hypothesized that there is a relationship between hypertension, diabetes mellitus and decreased cardiac reserve and efficiency and that PRAM parameters may identify this. Also, the static or dynamic PRAM parameters may predict pre-incision hypotension in patients wo will undergo major surgical procedures.

In order to test these hypothesis, a prospective cohort study was planned, as the outcome has a very short latency and the intent is to observe the outcome, not to prevent or treat it. The investigators aim to collect high quality hemodynamic data from normotensive, hypertensive, and untreated hypertensive patients. In order to obtain sufficient relevant data, only patients scheduled for major surgeries will be included. Patients who are planned to be monitored with the MostCare hemodynamic monitor, and who need a passive leg raising test will be included in the study.

Hypertension is the most prevalent of cardiovascular risk factors, namely diabetes mellitus, coronary artery disease, smoking, obesity, and dyslipidemia, which may present as either the mediator or cofounder of hypertension. Therefore a detailed medical history including information relevant to these conditions will be collected.

Вмешательства

• Диагностический тест Passive leg raising
  All patients who met the inclusion criteria will be placed head down flat and feet up at a 45° angle for 30 seconds. Hemodynamic parameters and analysis by pressure recording analytical method obtained with the MostCare will be collected before, during and after the test until the end of the surgery. The total duration of the intervention (passive leg raising) is 30 seconds. The total duration of hemodynamic parameters recording is expected to be 60-600 minutes.

Первичные конечные точки

• Difference of mean CCE, dP/dt, SVI, CPI, Ea by hypertension and diabetes mellitus [Срок оценки: From the start of surgery until the end of surgery]
• Difference of mean CCE, dP/dt, SVI, CPI, Ea at the 30th second of passive leg raising by hypertension and diabetes mellitus [Срок оценки: From the start of passive leg raising test until the end of the test]

Вторичные конечные точки (4)

• Number of Participants With Mean Arterial Blood Pressure < 65 mmHg Within 5 Minutes Following Tracheal Intubation [Срок оценки: From the start of surgery until the end of surgery]
• Number of Participants With Mean Arterial Blood Pressure < 65 mmHg Between Tracheal Intubation and Surgical Incision [Срок оценки: From the start of surgery until the end of surgery]
• Number of Participants With Mean Arterial Blood Pressure < 65 mmHg During the Surgery [Срок оценки: From the start of surgery until the end of surgery]
• Predictive factors of hypotension [Срок оценки: From the start of surgery until the end of surgery]

Критерии участия

Критерии включения

• Age at least 18 years
• Undergoing major surgery under general anesthesia
• Expected surgery time >2 h
• Expected length of postoperative stay >2 d
• Invasive blood pressure (radial or femoral) and Mostcare monitoring
• Indication for a passive leg raising test: risk of hypovolemia (preoperative fasting, bowel preparation, loss of appetite, limited access to water) or expected major surgery, expected blood loss, cardiovascular comorbidity (hypertension, diabetes mellitus, coronary artery disease, peripheral artery disease, hyperlipidemia, morbidity, active smoking).
• Recruitment after booking for surgery with sufficient time to read, understand and question study patient information prior to attending for surgery.
• Ability and willingness to provide informed consent

Критерии исключения

• Refuse to consent to the study
• Arterial wave form distortion
• Cardiac arrhythmia
• Inappropriate identification of the dicrotic notch for any reason
• Planned intraoperative mean arterial blood pressure < 65 mmHg
• Hemodynamic instability defined as mean arterial blood pressure < 65 mmHg
• Preoperative requirement of inotrope/vasopressor infusion
• Preoperatively receiving vasoactive drugs
• Patients fitted with an intra-aortic balloon pump
• Patients fitted with Extracorporeal Membrane Oxygenation
• Critically ill patients requiring preoperative intensive care unit
• Presence of intraabdominal hypertension
• New York Heart Association Class 3-4 heart failure
• Congestive heart failure with ejection fraction < 35%
• Glomerular filtration rate < 30 ml/min/1.73 m2
• Ongoing renal replacement therapy

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Turkey (Türkiye) · 5 центров

• Gazi University Medical Faculty, Department of Anesthesiology and Reanimation — Ankara
• Erzurum Atatürk University Medical Faculty, Department of Anesthesiology and Reanimation — Erzurum
• Başakşehir Çam ve Sakura City Hospital, University Medical Faculty, Anesthesiology and Rea — Istanbul
• Acıbadem University Medical Faculty, Department of Anesthesiology and Reanimation — Istanbul
• Recep Tayyip Erdogan University Medical Faculty, Department of Anesthesiology and Reanimat — Rize

Публикации

• Choudhry NK, Kronish IM, Vongpatanasin W, Ferdinand KC, Pavlik VN, Egan BM, Schoenthaler A, Houston Miller N, Hyman DJ; American Heart Association Council on Hypertension; Council on Cardiovascular and Stroke Nursing; and Council on Clinical Cardiology. Medication Adherence and Blood Pressure Control: A Scientific Statement From the American Heart Association. Hypertension. 2022 Jan;79(1):e1-e14. PMID 34615363
• Burnier M, Egan BM. Adherence in Hypertension. Circ Res. 2019 Mar 29;124(7):1124-1140. doi: 10.1161/CIRCRESAHA.118.313220. PMID 30920917
• Sudfeld S, Brechnitz S, Wagner JY, Reese PC, Pinnschmidt HO, Reuter DA, Saugel B. Post-induction hypotension and early intraoperative hypotension associated with general anaesthesia. Br J Anaesth. 2017 Jul 1;119(1):57-64. doi: 10.1093/bja/aex127. PMID 28974066
• Zhang H, Gao H, Xiang Y, Li J. Maximum inferior vena cava diameter predicts post-induction hypotension in hypertensive patients undergoing non-cardiac surgery under general anesthesia: A prospective cohort study. Front Cardiovasc Med. 2022 Oct 4;9:958259. doi: 10.3389/fcvm.2022.958259. eCollection 2022. PMID 36267641
• Chantler PD, Lakatta EG, Najjar SS. Arterial-ventricular coupling: mechanistic insights into cardiovascular performance at rest and during exercise. J Appl Physiol (1985). 2008 Oct;105(4):1342-51. doi: 10.1152/japplphysiol.90600.2008. Epub 2008 Jul 10. PMID 18617626
• Borlaug BA, Melenovsky V, Redfield MM, Kessler K, Chang HJ, Abraham TP, Kass DA. Impact of arterial load and loading sequence on left ventricular tissue velocities in humans. J Am Coll Cardiol. 2007 Oct 16;50(16):1570-7. doi: 10.1016/j.jacc.2007.07.032. Epub 2007 Oct 1. PMID 17936156
• Ikonomidis I, Aboyans V, Blacher J, Brodmann M, Brutsaert DL, Chirinos JA, De Carlo M, Delgado V, Lancellotti P, Lekakis J, Mohty D, Nihoyannopoulos P, Parissis J, Rizzoni D, Ruschitzka F, Seferovic P, Stabile E, Tousoulis D, Vinereanu D, Vlachopoulos C, Vlastos D, Xaplanteris P, Zimlichman R, Metra M. The role of ventricular-arterial coupling in cardiac disease and heart failure: assessment, clin PMID 30859669
• Kuznetsova T, D'hooge J, Kloch-Badelek M, Sakiewicz W, Thijs L, Staessen JA. Impact of hypertension on ventricular-arterial coupling and regional myocardial work at rest and during isometric exercise. J Am Soc Echocardiogr. 2012 Aug;25(8):882-90. doi: 10.1016/j.echo.2012.04.018. Epub 2012 May 22. PMID 22622108

Идентификаторы

NCT: NCT05960604 · PRAM-in-HYPO

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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