Arterial Elastance: A Predictor of Hypotension Due to Anesthesia Induction

December 9, 2022 updated by: Serap Aktaş, Acibadem University
Hypotension is very common during and after anesthesia induction. A prolonged fasting period, a patient's underlying comorbidities, a sympathetic blockade by anesthetic agents, vasodilation, a reduction in preload, and cardiac contractility can cause post-induction hypotension.1,2 The relationship of even short-term hypotension with myocardial damage, renal injury, and stroke has been shown in many studies; therefore, it is very important to provide stable anesthesia induction.3 In current anesthesia practice, we can only intervene when hypotension occurs. If we can identify patients who may experience hypotension during anesthesia induction before it occurs, we can prevent possible postoperative organ dysfunctions by reducing the duration and depth of hypotension with prophylactic fluid and vasopressor administration. We hypothesized that arterial elastance (Ea) values before anesthesia induction could predict post-induction hypotension. To test our hypothesis, we aimed to investigate the reliability of the Ea value, which was monitored preoperatively using the pressure analytical recording method (PRAM) to predict the risk of hypotension that may occur after anesthesia induction.

Study Overview

Status

Completed

Detailed Description

Anesthesia induction-related hypotension is not uncommon and is still challenging for anesthesiologists to predict, despite advanced monitoring techniques. In current anesthesia practices, approximately 20-30% of patients develop hypotension during and after anesthesia induction. In large observational studies, the relationship between intraoperative hypotension and adverse cardiac, renal, and cerebral outcomes has been reported. Approximately one-third of intraoperative hypotension episodes occur during and after the induction of anesthesia, and most can be prevented if foreseeable. Therefore, we need quick and easy markers to predict patients at risk of hypotension to achieve the stable induction of anesthesia.

Many studies have used noninvasive and invasive monitoring techniques for the preoperative prediction of hypotension after anesthesia induction.

However, most studies evaluate the cardiovascular system with parameters that determine the preload and fluid responsiveness to predict the risk of post-induction hypotension, though the arterial system and its interaction with the ventricle are ignored.The heart and the arterial system are both anatomically and functionally interconnected and do not act independently. The major determinant of cardiovascular system performance and cardiac energetics is ventriculoarterial coupling (VAC). Ea is an indicator of cardiac afterload and arterial tone and can be calculated by the ratio of the end-systolic pressure (ESP) and stroke volume (SV) obtained from arterial wave analysis.Ea provides information about the ESP/SV relationship and dynamic afterload and gives the clinician the opportunity to evaluate VAC indirectly. We hypothesized that Ea values before anesthesia induction could predict post-induction hypotension. To test our hypothesis, we aimed to investigate the reliability of the Ea value, which was monitored preoperatively using the pressure analytical recording method (PRAM) to predict the risk of hypotension that may occur after anesthesia induction.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Istanbul, Turkey, 31190
        • Acibadem Altunizade Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with ASA physical status 1-3 who underwent major elective surgery

Description

Inclusion Criteria:

  • Patients with ASA( American Society Of Anesthesiology) physical status 1-3
  • Underwent major elective surgery
  • Required intra-arterial blood pressure monitoring before induction.

Exclusion Criteria:

  • Under 18 years of age
  • Arrhythmia (atrial fibrillation, frequent premature beat)
  • Severe pre-existing lung disease
  • Severe valvular heart disease
  • morbid obesity
  • emergency surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arterial elastance (Ea) measured before anesthesia induction was investigated whether is a predictive parameter for post-induction hypotension in patients undergoing general anesthesia.
Time Frame: The duration of the study was defined from one minute before induction to 10 minutes after induction
Ea ((mmHg m-2ml-1)is an indicator of cardiac afterload and arterial tone and can be calculated by the ratio of the end-systolic pressure (ESP) and stroke volume (SV) obtained from arterial wave analysis. Ea was monitored using the uncalibrated pulse contour device MostCare (Vytech, Vygon, Padova, Italy) before the anesthesia induction
The duration of the study was defined from one minute before induction to 10 minutes after induction

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stroke volume variation (SVV), measured before anesthesia induction were assessed for prediction of post-induction hypotension in patients undergoing general anesthesia
Time Frame: The duration of the study was defined from one minute before induction to 10 minutes after induction
Stroke volume variation (SVV,%), was monitored using the uncalibrated pulse contour device MostCare (Vytech, Vygon, Padova, Italy). SVV is a parameter used to asses cardiac preload and fluid responsiveness
The duration of the study was defined from one minute before induction to 10 minutes after induction

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pulse pressure variation (PPV), measured before anesthesia induction were assessed for prediction of post-induction hypotension in patients undergoing general anesthesia
Time Frame: The duration of the study was defined from one minute before induction to 10 minutes after induction
Pulse pressure variation (PPV,%) was monitored using the uncalibrated pulse contour device MostCare (Vytech, Vygon, Padova, Italy). PPV is a parameter used to asses cardiac preload and fluid responsiveness.
The duration of the study was defined from one minute before induction to 10 minutes after induction
Cardiac power output (CPO), measured before anesthesia induction were assessed for prediction of post-induction hypotension in patients undergoing general anesthesia
Time Frame: The duration of the study was defined from one minute before induction to 10 minutes after induction
Cardiac power output (CPO, Watt) was monitored using the uncalibrated pulse contour device MostCare (Vytech, Vygon, Padova, Italy). CPO is a parameter used to asses cardiac reserve
The duration of the study was defined from one minute before induction to 10 minutes after induction
Cardiac index (CI), measured before anesthesia induction were assessed for prediction of post-induction hypotension in patients undergoing general anesthesia
Time Frame: The duration of the study was defined from one minute before induction to 10 minutes after induction
Cardiac index (CI, L/min/m2), was monitored using the uncalibrated pulse contour device MostCare (Vytech, Vygon, Padova, Italy). CI is a parameter used to asses cardiac stroke volume
The duration of the study was defined from one minute before induction to 10 minutes after induction
Dp/Dt, measured before anesthesia induction were assessed for prediction of post-induction hypotension in patients undergoing general anesthesia
Time Frame: The duration of the study was defined from one minute before induction to 10 minutes after induction
Dp/Dt(mmHg/msn), was monitored using the uncalibrated pulse contour device MostCare (Vytech, Vygon, Padova, Italy). Dp/Dt is a parameter used to asses cardiac contractility.
The duration of the study was defined from one minute before induction to 10 minutes after induction
Systolic arterial pressure (SAP), measured before anesthesia induction were assessed for prediction of post-induction hypotension in patients undergoing general anesthesia
Time Frame: The duration of the study was defined from one minute before induction to 10 minutes after induction
Systolic arterial pressure (SAP- mm/Hg) was monitored using the uncalibrated pulse contour device MostCare (Vytech, Vygon, Padova, Italy). SAP is a parameter used to assess the pressure of the arterial system during cardiac systole
The duration of the study was defined from one minute before induction to 10 minutes after induction
diastolic arterial pressure (DAP), measured before anesthesia induction were assessed for prediction of post-induction hypotension in patients undergoing general anesthesia
Time Frame: The duration of the study was defined from one minute before induction to 10 minutes after induction
Diastolic arterial pressure (DAP, mm/Hg) was monitored using the uncalibrated pulse contour device MostCare (Vytech, Vygon, Padova, Italy). DAP is a parameter used to assess the pressure of the arterial system during cardiac diastole.
The duration of the study was defined from one minute before induction to 10 minutes after induction
mean arterial pressure (MAP), measured before anesthesia induction were assessed for prediction of post-induction hypotension in patients undergoing general anesthesia
Time Frame: The duration of the study was defined from one minute before induction to 10 minutes after induction
Mean arterial pressure (MAP, mm/Hg) was monitored using the uncalibrated pulse contour device MostCare (Vytech, Vygon, Padova, Italy). MAP is a parameter used to assess organ perfusion.
The duration of the study was defined from one minute before induction to 10 minutes after induction
Heart rate (HR), measured before anesthesia induction were assessed for prediction of post-induction hypotension in patients undergoing general anesthesia
Time Frame: The duration of the study was defined from one minute before induction to 10 minutes after induction
Heart rate (HR/bpm) was monitored using the uncalibrated pulse contour device MostCare (Vytech, Vygon, Padova, Italy). HR is a parameter used to assess the cardiac rate.
The duration of the study was defined from one minute before induction to 10 minutes after induction

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

August 15, 2022

Study Registration Dates

First Submitted

November 26, 2022

First Submitted That Met QC Criteria

December 9, 2022

First Posted (Estimate)

December 13, 2022

Study Record Updates

Last Update Posted (Estimate)

December 13, 2022

Last Update Submitted That Met QC Criteria

December 9, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATADEK 2021-10/21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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