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

NCT05960604 | Recruiting DMC

• 1 other identifier: PRAM-in-HYPO
• Study Type: observational
• Target: 660
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Cardiovascular Diseases; Surgery; Hypotension; Hypotension on Induction; Hypotension During Surgery

Keywords

Mostcare; Pressure Recording Analytical Method; Pulse contour analysis; Hemodynamic monitoring; Effective arterial elastance; Cardiac cycle efficiency; Cardiac power output; Myocardial contraction; Cardiac output; Stroke volume; Systemic vascular resistance

Outcome Measures

Primary Outcomes (2)

• Difference of mean CCE, dP/dt, SVI, CPI, Ea by hypertension and diabetes mellitus

  Difference in baseline PRAM parameters between patients who have hypertension, diabetes mellitus and other cardiovascular diseases and those who have none.

  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

  Difference in the magnitude of the changes observed in PRAM parameters after a passive leg raising test between patients who have hypertension, diabetes mellitus and other cardiovascular diseases and those who have none.

  From the start of passive leg raising test until the end of the test

Secondary Outcomes (4)

• Number of Participants With Mean Arterial Blood Pressure < 65 mmHg Within 5 Minutes Following Tracheal Intubation

  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

  From the start of surgery until the end of surgery

• Number of Participants With Mean Arterial Blood Pressure < 65 mmHg During the Surgery

  From the start of surgery until the end of surgery

• Predictive factors of hypotension

  From the start of surgery until the end of surgery

Other Outcomes (9)

• Time to discharge from PACU

  From the end of surgery until the discharge from the post anesthesia care unit, up to 7 days

• Time to extubation

  From the end of surgery until the tracheal extubation, up to 7 days

• Time to discharge from ICU

  From the end of surgery until the discharge from the intensive care unit, up to 7 days

Study Arms (2)

Low cardiac reserve/efficiency

Patients who were identified as having low cardiac reserve and efficiency, based on PRAM parameters.

Diagnostic Test: Passive leg raising

Normal cardiac reserve/efficiency

Patients who were identified as having normal cardiac reserve and efficiency, based on PRAM parameters.

Diagnostic Test: Passive leg raising

Interventions

Passive leg raising DIAGNOSTIC_TEST

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.

Low cardiac reserve/efficiency; Normal cardiac reserve/efficiency

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are scheduled for any major surgery will be included. Major surgery includes a broad list of cardiac surgery, thoracic surgery, hepatic surgery, pancreatic surgery, colorectal surgery, major orthopedic surgeries, cancer surgeries, where blood loss or intravascular volume loss is expected due to factors related to the patient or surgery.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Turkish Society of Thoracic and Cardio-Vascular Anesthesia and Intensive Care: collaborator
• Recep Tayyip Erdogan University: lead

Study Sites (5)

Gazi University Medical Faculty, Department of Anesthesiology and Reanimation

Ankara, 06560, Turkey (Türkiye)

RECRUITING

Erzurum Atatürk University Medical Faculty, Department of Anesthesiology and Reanimation

Erzurum, 25240, Turkey (Türkiye)

RECRUITING

Başakşehir Çam ve Sakura City Hospital, University Medical Faculty, Anesthesiology and Reanimation Clinic

Istanbul, 34480, Turkey (Türkiye)

RECRUITING

Acıbadem University Medical Faculty, Department of Anesthesiology and Reanimation

Istanbul, 34755, Turkey (Türkiye)

RECRUITING

Recep Tayyip Erdogan University Medical Faculty, Department of Anesthesiology and Reanimation

Rize, 53100, Turkey (Türkiye)

NOT YET RECRUITING

Related Publications (19)

• 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. doi: 10.1161/HYP.0000000000000203. Epub 2021 Oct 7.

  PMID: 34615363 BACKGROUND

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• 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 BACKGROUND

• 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 BACKGROUND

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  PMID: 17936156 BACKGROUND

• 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, clinical implications and therapeutic interventions. A consensus document of the European Society of Cardiology Working Group on Aorta & Peripheral Vascular Diseases, European Association of Cardiovascular Imaging, and Heart Failure Association. Eur J Heart Fail. 2019 Apr;21(4):402-424. doi: 10.1002/ejhf.1436. Epub 2019 Mar 12.

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• 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 BACKGROUND

• Lam CS, Shah AM, Borlaug BA, Cheng S, Verma A, Izzo J, Oparil S, Aurigemma GP, Thomas JD, Pitt B, Zile MR, Solomon SD. Effect of antihypertensive therapy on ventricular-arterial mechanics, coupling, and efficiency. Eur Heart J. 2013 Mar;34(9):676-83. doi: 10.1093/eurheartj/ehs299. Epub 2012 Sep 10.

  PMID: 22963833 BACKGROUND

• Guinot PG, Longrois D, Kamel S, Lorne E, Dupont H. Ventriculo-Arterial Coupling Analysis Predicts the Hemodynamic Response to Norepinephrine in Hypotensive Postoperative Patients: A Prospective Observational Study. Crit Care Med. 2018 Jan;46(1):e17-e25. doi: 10.1097/CCM.0000000000002772.

  PMID: 29019850 BACKGROUND

• Ikonomidis I, Katsanos S, Triantafyllidi H, Parissis J, Tzortzis S, Pavlidis G, Trivilou P, Makavos G, Varoudi M, Frogoudaki A, Vrettou AR, Vlastos D, Lekakis J, Iliodromitis E. Pulse wave velocity to global longitudinal strain ratio in hypertension. Eur J Clin Invest. 2019 Feb;49(2):e13049. doi: 10.1111/eci.13049. Epub 2018 Dec 19.

  PMID: 30422317 BACKGROUND

• Romano SM. Cardiac cycle efficiency: a new parameter able to fully evaluate the dynamic interplay of the cardiovascular system. Int J Cardiol. 2012 Mar 8;155(2):326-7. doi: 10.1016/j.ijcard.2011.12.008. Epub 2011 Dec 22. No abstract available.

  PMID: 22197117 BACKGROUND

• Sahiti F, Morbach C, Cejka V, Tiffe T, Wagner M, Eichner FA, Gelbrich G, Heuschmann PU, Stork S. Impact of cardiovascular risk factors on myocardial work-insights from the STAAB cohort study. J Hum Hypertens. 2022 Mar;36(3):235-245. doi: 10.1038/s41371-021-00509-4. Epub 2021 Mar 2.

  PMID: 33654241 BACKGROUND

• Siripruekpong S, Geater A, Cheewatanakornkul S. Comparison of intraoperative arterial blood pressure lability during general anaesthesia in masked, uncontrolled hypertensive and adequately controlled hypertensive patients: a prospective observational study. Anaesthesiol Intensive Ther. 2022;54(5):402-412. doi: 10.5114/ait.2022.123143.

  PMID: 36734451 BACKGROUND

• Salim F, Khan F, Nasir M, Ali R, Iqbal A, Raza A. Frequency of Intraoperative Hypotension After the Induction of Anesthesia in Hypertensive Patients with Preoperative Angiotensin-converting Enzyme Inhibitors. Cureus. 2020 Jan 9;12(1):e6614. doi: 10.7759/cureus.6614.

  PMID: 32064194 BACKGROUND

• Hojo T, Kimura Y, Shibuya M, Fujisawa T. Predictors of hypotension during anesthesia induction in patients with hypertension on medication: a retrospective observational study. BMC Anesthesiol. 2022 Nov 11;22(1):343. doi: 10.1186/s12871-022-01899-9.

  PMID: 36368916 BACKGROUND

• Bijker JB, van Klei WA, Kappen TH, van Wolfswinkel L, Moons KG, Kalkman CJ. Incidence of intraoperative hypotension as a function of the chosen definition: literature definitions applied to a retrospective cohort using automated data collection. Anesthesiology. 2007 Aug;107(2):213-20. doi: 10.1097/01.anes.0000270724.40897.8e.

  PMID: 17667564 BACKGROUND

• Walsh M, Devereaux PJ, Garg AX, Kurz A, Turan A, Rodseth RN, Cywinski J, Thabane L, Sessler DI. Relationship between intraoperative mean arterial pressure and clinical outcomes after noncardiac surgery: toward an empirical definition of hypotension. Anesthesiology. 2013 Sep;119(3):507-15. doi: 10.1097/ALN.0b013e3182a10e26.

  PMID: 23835589 BACKGROUND

• Jor O, Maca J, Koutna J, Gemrotova M, Vymazal T, Litschmannova M, Sevcik P, Reimer P, Mikulova V, Trlicova M, Cerny V. Hypotension after induction of general anesthesia: occurrence, risk factors, and therapy. A prospective multicentre observational study. J Anesth. 2018 Oct;32(5):673-680. doi: 10.1007/s00540-018-2532-6. Epub 2018 Jul 19.

  PMID: 30027443 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases; Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases

Study Officials

• Fevzi Toraman, Prof.

  Acibadem University

  STUDY DIRECTOR

Central Study Contacts

Başar Erdivanlı, Assoc. Prof.

CONTACT

+90-505-7800730; basar.erdivanli@erdogan.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Başar Erdivanlı

Study Record Dates

• First Submitted: April 7, 2023
• First Posted: July 27, 2023
• Study Start: February 19, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 9, 2025

Record last verified: 2025-04

Locations

TU (5)