Clinical trial NCT05960604: Pressure Recording Analytical Method Parameters and Their Relationship With Hypotension in Hypertensive Patients
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: Recep Tayyip Erdogan University
Sponsor class: OTHER
Collaborators: name: Turkish Society of Thoracic and Cardio-Vascular Anesthesia and Intensive Care
First posted: 2023-07-27
Enrollment: 660
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: Untreated hypertension decreases the cardiac reserve through several mechanisms, which are augmented by other cardiovascular risk factors such as diabetes mellitus and coronary artery disease. Perioperative stress on top of these overlapping diseases causes wide variations in the arterial blood pressure. From the anesthesiologist's point of view, this translates into a wide variation in response to surgical stress among patients with seemingly similar cardiovascular risk factors.

The cardiac reserve may be measured by cardiac catheterization or echocardiography, none of which are feasible during a surgery. Recently, some parameters of the Pressure Recording Analytical Method (PRAM) were shown to be affected by hypertension or intraoperative events such as pneumoperitoneum and position changes. This suggests that PRAM may be used to evaluate the risk of adverse hemodynamic events in newly diagnosed, untreated hypertensive patients.

The investigators hypothesized that there is a relationship between hypertension, diabetes mellitus and decreased cardiac reserve and efficiency and that PRAM parameters may identify this. Also, the static or dynamic PRAM parameters may predict pre-incision hypotension in patients wo will undergo major surgical procedures.

In order to test these hypothesis, a prospective cohort study was planned, as the outcome has a very short latency and the intent is to observe the outcome, not to prevent or treat it. The investigators aim to collect high quality hemodynamic data from normotensive, hypertensive, and untreated hypertensive patients. In order to obtain sufficient relevant data, only patients scheduled for major surgeries will be included. Patients who are planned to be monitored with the MostCare hemodynamic monitor, and who need a passive leg raising test will be included in the study.

Hypertension is the most prevalent of cardiovascular risk factors, namely diabetes mellitus, coronary artery disease, smoking, obesity, and dyslipidemia, which may present as either the mediator or cofounder of hypertension. Therefore a detailed medical history including information relevant to these conditions will be collected.

Eligibility criteria: 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

Primary outcomes:
measure: Difference of mean CCE, dP/dt, SVI, CPI, Ea by hypertension and diabetes mellitus
timeFrame: From the start of surgery until the end of surgery
measure: Difference of mean CCE, dP/dt, SVI, CPI, Ea at the 30th second of passive leg raising by hypertension and diabetes mellitus
timeFrame: From the start of passive leg raising test until the end of the test
Secondary outcomes:
measure: Number of Participants With Mean Arterial Blood Pressure < 65 mmHg Within 5 Minutes Following Tracheal Intubation
timeFrame: From the start of surgery until the end of surgery
measure: Number of Participants With Mean Arterial Blood Pressure < 65 mmHg Between Tracheal Intubation and Surgical Incision
timeFrame: From the start of surgery until the end of surgery
measure: Number of Participants With Mean Arterial Blood Pressure < 65 mmHg During the Surgery
timeFrame: From the start of surgery until the end of surgery
measure: Predictive factors of hypotension
timeFrame: From the start of surgery until the end of surgery
Other outcomes:
measure: Time to discharge from PACU
timeFrame: From the end of surgery until the discharge from the post anesthesia care unit, up to 7 days
measure: Time to extubation
timeFrame: From the end of surgery until the tracheal extubation, up to 7 days
measure: Time to discharge from ICU
timeFrame: From the end of surgery until the discharge from the intensive care unit, up to 7 days
measure: Time to discharge from hospital
timeFrame: From the end of surgery until the discharge from the hospital, up to 7 days
measure: MINS7
timeFrame: From the end of surgery until the discharge from the hospital, up to 7 days
measure: MACE7
timeFrame: From the end of surgery until the discharge from the hospital, up to 7 days
measure: MAKE7
timeFrame: From the end of surgery until the discharge from the hospital, up to 7 days
measure: Survival
timeFrame: From the end of surgery until the discharge from the hospital, up to 7 days
measure: Days out of hospital 30
timeFrame: From the end of surgery until postoperative day 30
Locations:
city: Ankara
country: Turkey
facility: Gazi University Medical Faculty, Department of Anesthesiology and Reanimation
city: Erzurum
country: Turkey
facility: Erzurum Atatürk University Medical Faculty, Department of Anesthesiology and Reanimation
city: Istanbul
country: Turkey
facility: Başakşehir Çam ve Sakura City Hospital, University Medical Faculty, Anesthesiology and Reanimation Clinic
city: İstanbul
country: Turkey
facility: Acıbadem University Medical Faculty, Department of Anesthesiology and Reanimation
city: Rize
country: Turkey
facility: Recep Tayyip Erdogan University Medical Faculty, Department of Anesthesiology and Reanimation
Study officials:
affiliation: Acibadem University
name: Fevzi Toraman, Prof.
role: STUDY_DIRECTOR
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