Ignite Creation Date:
2024-05-06 @ 7:17 PM
Last Modification Date:
2025-12-16 @ 6:16 PM
Study NCT ID:
NCT05960604
Status:
None
Last Update Posted:
2025-04-09 00:00:00
First Post:
2023-04-07 00:00:00
Brief Title:
Pressure Recording Analytical Method Parameters and Their Relationship With Hypotension in Hypertensive Patients
Sponsor:
Recep Tayyip Erdogan University
Organization:
Recep Tayyip Erdogan University
Study Overview
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
Status:
None
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRAM-in-HYPO
Brief Summary:
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.
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.
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 anesthesiologists 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None