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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Turkey
Gazi University Medical Faculty, Department of Anesthesiology and Reanimation
RECRUITING
Ankara
Erzurum Atatürk University Medical Faculty, Department of Anesthesiology and Reanimation
RECRUITING
Erzurum
Acıbadem University Medical Faculty, Department of Anesthesiology and Reanimation
RECRUITING
Istanbul
Başakşehir Çam ve Sakura City Hospital, University Medical Faculty, Anesthesiology and Reanimation Clinic
RECRUITING
Istanbul
Recep Tayyip Erdogan University Medical Faculty, Department of Anesthesiology and Reanimation
NOT_YET_RECRUITING
Rize
Contact Information
Primary
Başar Erdivanlı, Assoc. Prof.
basar.erdivanli@erdogan.edu.tr
+90-505-7800730
Time Frame
Start Date: 2024-02-19
Estimated Completion Date: 2027-06
Participants
Target number of participants: 660
Treatments
Low cardiac reserve/efficiency
Patients who were identified as having low cardiac reserve and efficiency, based on PRAM parameters.
Normal cardiac reserve/efficiency
Patients who were identified as having normal cardiac reserve and efficiency, based on PRAM parameters.
Related Therapeutic Areas
Sponsors
Leads: Recep Tayyip Erdogan University
Collaborators: Turkish Society of Thoracic and Cardio-Vascular Anesthesia and Intensive Care

This content was sourced from clinicaltrials.gov