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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRecep Tayyip Erdogan University

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Passive leg raising

    Diagnostic test

    All 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

660 Participants
are divided into 2 treatment groups
Group A: Low cardiac reserve/efficiency1 intervention
Group B: Normal cardiac reserve/efficiency1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From the start of surgery until the end of surgery
2

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.

Time frame
From the start of passive leg raising test until the end of the test

Secondary outcomes

1

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.

Time frame
From the start of surgery until the end of surgery
2

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.

Time frame
From the start of surgery until the end of surgery
3

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.

Time frame
From the start of surgery until the end of surgery
4

Predictive factors of hypotension

Identification of patient characteristics and arterial pressure waveform parameters associated with hypotension. A multiple logistic regression analysis will be performed.

Time frame
From the start of surgery until the end of surgery

Other outcomes

1

Time to discharge from PACU

Time (hours) required for discharge from the post-anesthesia care unit.

Time frame
From the end of surgery until the discharge from the post anesthesia care unit, up to 7 days
2

Time to extubation

Time (hours) required for tracheal extubation.

Time frame
From the end of surgery until the tracheal extubation, up to 7 days
3

Time to discharge from ICU

Time (days) required for discharge from the intensive care unit.

Time frame
From the end of surgery until the discharge from the intensive care unit, up to 7 days
4

Time to discharge from hospital

Time (days) required for discharge from the hospital.

Time frame
From the end of surgery until the discharge from the hospital, up to 7 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Recep Tayyip Erdogan University

Lead sponsor

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

Collaborator