About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Age at least 18 years
Undergoing major surgery under general anesthesia
Expected surgery time >2 h
Expected length of postoperative stay >2 d
Disqualifiers
Refuse to consent to the study
Arterial wave form distortion
Cardiac arrhythmia
Inappropriate identification of the dicrotic notch for any reason
Trial 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.
Trial design
Cohort
Prospective
Treatments tested in this trial
Passive leg raising
Diagnostic testAll 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
Secondary outcomes
Number of Participants With Mean Arterial Blood Pressure < 65 mmHg Within 5 Minutes Following Tracheal Intubation
Hypotension, defined as mean arterial blood pressure \< 65 mmHg, within 5 minutes after tracheal intubation.
Number of Participants With Mean Arterial Blood Pressure < 65 mmHg Between Tracheal Intubation and Surgical Incision
Hypotension, defined as mean arterial blood pressure \< 65 mmHg, between 5 minutes after tracheal intubation and surgical incision.
Number of Participants With Mean Arterial Blood Pressure < 65 mmHg During the Surgery
Hypotension, defined as mean arterial blood pressure \< 65 mmHg, between surgical incision and end of surgery.
Predictive factors of hypotension
Identification of patient characteristics and arterial pressure waveform parameters associated with hypotension. A multiple logistic regression analysis will be performed.
Other outcomes
Time to discharge from PACU
Time (hours) required for discharge from the post-anesthesia care unit.
Time to extubation
Time (hours) required for tracheal extubation.
Time to discharge from ICU
Time (days) required for discharge from the intensive care unit.
Time to discharge from hospital
Time (days) required for discharge from the hospital.
Sponsors and contacts
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Recep Tayyip Erdogan University
Lead sponsor
Turkish Society of Thoracic and Cardio-Vascular Anesthesia and Intensive Care
Collaborator