Pressure Recording Analytical Method Parameters and Their Relationship With Hypotension in Hypertensive Patients
Recruiting · NCT05960604 · Observational (researchers observe without assigning treatment) · Lead sponsor: Recep Tayyip Erdogan University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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
Exclusion criteria
- 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
Where it is running
5 locations listed.
- Gazi University Medical Faculty, Department of Anesthesiology and Reanimation - Ankara, Turkey (Türkiye)
- Erzurum Atatürk University Medical Faculty, Department of Anesthesiology and Reanimation - Erzurum, Turkey (Türkiye)
- Başakşehir Çam ve Sakura City Hospital, University Medical Faculty, Anesthesiology and Reanimation Clinic - Istanbul, Turkey (Türkiye)
- Acıbadem University Medical Faculty, Department of Anesthesiology and Reanimation - Istanbul, Turkey (Türkiye)
- Recep Tayyip Erdogan University Medical Faculty, Department of Anesthesiology and Reanimation - Rize, Turkey (Türkiye)