Actively Recruiting

Age: 18Years +
All Genders
ID05960604

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

Led by Recep Tayyip Erdogan University · Updated on 2025-04-09

660

Participants Needed

5

Research Sites

26 weeks

Total Duration

On this page

Sponsors

R

Recep Tayyip Erdogan University

Lead Sponsor

T

Turkish Society of Thoracic and Cardio-Vascular Anesthesia and Intensive Care

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating how well certain heart function measurements, called Pressure Recording Analytical Method (PRAM) parameters, relate to cardiovascular risk factors like hypertension and diabetes in patients undergoing major surgery. The study aims to understand how these measurements can identify patients at risk of low blood pressure after anesthesia induction, which is important for improving patient care during surgery. The research is designed as an observational study and focuses especially on patients with hypertension and other cardiovascular risks undergoing major surgical procedures. Participants will be monitored using advanced hemodynamic devices, including the MostCare system, which measures PRAM parameters. All patients will undergo a passive leg raising test lasting 30 seconds to help assess their cardiovascular status. Hemodynamic data will be collected before, during, and after the test and throughout the surgery, which typically lasts between one and ten hours. The study will include patients with both low and normal cardiac reserve and efficiency as determined by PRAM parameters. During the study, participants will be closely observed with invasive blood pressure monitoring and the MostCare device. Researchers will collect detailed medical histories and measure various cardiac-related parameters from the start of surgery until its completion. They will track occurrences of low blood pressure after anesthesia and examine factors that predict such hypotension. Participation involves major surgery lasting more than two hours and at least two days of postoperative hospital stay. The entire monitoring period may last up to 10 hours, with ongoing evaluations during this time.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age at least 18 years
  • Scheduled for major surgery under general anesthesia
  • Expected surgery duration longer than 2 hours
  • Expected postoperative hospital stay longer than 2 days
  • Monitoring with invasive blood pressure and MostCare device planned
  • Indication for passive leg raising test due to risk factors such as hypovolemia, major surgery, expected blood loss, or cardiovascular comorbidities
  • Able and willing to provide informed consent
  • Recruitment after booking surgery with sufficient time to review study information
Not Eligible

You will not qualify if you...

  • Refusal to provide consent
  • Distorted arterial waveform
  • Cardiac arrhythmia
  • Inability to identify dicrotic notch properly
  • Planned intraoperative mean arterial pressure below 65 mmHg
  • Hemodynamic instability with mean arterial pressure below 65 mmHg
  • Preoperative use of inotrope or vasopressor infusion
  • Receiving vasoactive drugs before surgery
  • Use of intra-aortic balloon pump
  • Use of extracorporeal membrane oxygenation
  • Critically ill requiring preoperative intensive care
  • Intraabdominal hypertension
  • New York Heart Association Class 3 or 4 heart failure
  • Congestive heart failure with ejection fraction below 35%
  • Glomerular filtration rate less than 30 ml/min/1.73 m2
  • Ongoing renal replacement therapy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - From the start of surgery until the end of surgery (approximately 60 to 600 minutes)

Participants undergo a passive leg raising test with hemodynamic monitoring using the MostCare device to evaluate cardiac reserve and efficiency during surgery.

1 surgical visit with continuous monitoring during surgery

Long-term Monitoring

Duration - Duration of hospital stay after surgery (more than 2 days)

Medical history and relevant cardiovascular risk factors are collected to observe relationships with hemodynamic outcomes.

Postoperative hospital stay with routine assessments

Trial Site Locations

Total: 5 locations

1

Gazi University Medical Faculty, Department of Anesthesiology and Reanimation

Ankara, Turkey (Türkiye), 06560

Actively Recruiting

2

Erzurum Atatürk University Medical Faculty, Department of Anesthesiology and Reanimation

Erzurum, Turkey (Türkiye), 25240

Actively Recruiting

3

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

Istanbul, Turkey (Türkiye), 34480

Actively Recruiting

4

Acıbadem University Medical Faculty, Department of Anesthesiology and Reanimation

Istanbul, Turkey (Türkiye), 34755

Actively Recruiting

5

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

Rize, Turkey (Türkiye), 53100

Not Yet Recruiting

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Research Team

B

Başar Erdivanlı, Assoc. Prof.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

Medication Adherence and Blood Pressure Control: A Scientific Statement From the American Heart Association.

Niteesh K Choudhry, Ian M Kronish, Wanpen Vongpatanasin...

https://pubmed.ncbi.nlm.nih.gov/34615363

Maximum inferior vena cava diameter predicts post-induction hypotension in hypertensive patients undergoing non-cardiac surgery under general anesthesia: A prospective cohort study.

Hanying Zhang, Hongguang Gao, Yuanjun Xiang...

https://pubmed.ncbi.nlm.nih.gov/36267641

Arterial-ventricular coupling: mechanistic insights into cardiovascular performance at rest and during exercise.

Paul D Chantler, Edward G Lakatta, Samer S Najjar

https://pubmed.ncbi.nlm.nih.gov/18617626

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.

Ignatios Ikonomidis, Victor Aboyans, Jacque Blacher...

https://pubmed.ncbi.nlm.nih.gov/30859669

Impact of hypertension on ventricular-arterial coupling and regional myocardial work at rest and during isometric exercise.

Tatiana Kuznetsova, Jan D'hooge, Malgorzata Kloch-Badelek...

https://pubmed.ncbi.nlm.nih.gov/22622108

Ventriculo-Arterial Coupling Analysis Predicts the Hemodynamic Response to Norepinephrine in Hypotensive Postoperative Patients: A Prospective Observational Study.

Pierre-Grégoire Guinot, Dan Longrois, Said Kamel...

https://pubmed.ncbi.nlm.nih.gov/29019850