Ventricular-Arterial Coupling: A Predictor of Post-Induction Hypotension (VAC)

September 13, 2026 updated by: University Medical Center Ho Chi Minh City (UMC)

Predictive Value of Ventricular-Arterial Coupling for Post-Induction Hypotension: A Prospective Observational Cohort Study

Post-induction hypotension (PIH) is a common occurrence during the period from induction of general anesthesia to initiation of incision. PIH has been identified as an independent risk factor for postoperative major complications. Identifying high-risk patients for PIH could potentially help prevent its occurrence. Several risk factors associated with PIH have been identified, including patient conditions and use of specific anesthetic agents. Ventricular-arterial coupling (VAC) is evaluated using the ratio Ea/Ees and represents the interaction between the left ventricle (LV) and the arterial system. It reflects how changes in LV contractility (Ees) and changes in arterial load (Ea) work together to maintain optimal LV performance. A study aims to investigate the relationship between preoperative Ea/Ees ratio and the incidence of PIH (defined as MAP < 65 mmHg).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Post-induction hypotension (PIH) is a common event due to general anesthesia in patients undergoing surgery. It is described as hypotension occurring during the period from induction of general anesthesia to initiation of incision. A universal definition of intraoperative hypotension is lacking, leading to inconsistent rates of occurrence for PIH. According to Yoshimura et al., PIH occurs in 34% of patients using the mean arterial pressure (MAP) definition of < 55 mmHg, whereas Maheshwari found PIH in 53% of patients using a MAP definition of < 65 mmHg. Furthermore, Maheshwari et al. demonstrated that PIH was an independent risk factor for postoperative major complications such as myocardial injury, cerebrovascular events, and acute kidney injury.

If high-risk patients for PIH could be identified we might potentially prevent PIH. In a systematic review, Chen et al. pointed out that the risk factors associated with PIH were ASA (American Society of Anesthesiologists) III-V, advanced age, emergency cases, hypovolaemia, long-term use of angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, use of propofol and high-dose of opioid. This study suggests that PIH may be the result of an interaction between the anesthetic agent and the cardiovascular condition of the patient. Conditions such as moderate-to-severe aortic regurgitation, moderate-to-severe mitral regurgitation, regional wall motion abnormalities, and echocardiography findings (e.g. elevated ratio of peak early diastolic transmitral flow velocity to annular velocity) have been identified as PIH-independent risk factors.

End-systolic elastance (Ees) is a measure of the contractile state of the left ventricle (LV). It represents the relationship between LV end-systolic pressure (LVESP) and end-systolic volume (ESV). Effective arterial elastance (Ea) is a measure of the total arterial load on the LV and is calculated as the ratio of LVESP to stroke volume (SV). Ventricular-arterial coupling (VAC), assessed by the ratio Ea/Ees, describes the interaction between the LV and arterial system. VAC reflects the interplay between the changes in LV contractility (Ees) and changes in arterial load (Ea) to maintain optimal LV performance.

Aktas et al. analyzed Ea as a predictor of PIH. The results of this study showed that pre-induction Ea had excellent predictability of hypotension. However, Ees values were not determined, thus making it speculative to conclude that pre-induction VAC is impaired in patients with high Ea. There are no studies available that assessed the role of preoperative VAC in predicting PIH. Therefore, we will investigate the relationship between the preoperative Ea/Ees ratio and the incidence of PIH (: hypotension being defined as MAP < 65 mmHg).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
475

Contacts and Locations

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Study Contact

Study Contact

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Study Contact Backup

Study Locations

  • Vietnam
      • Ho Chi Minh City, Vietnam
        • University Medical Centre Ho Chi Minh

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with American Society of Anesthesiologists (ASA) physical status 1 - 4 who underwent elective surgery

Description

Inclusion Criteria:

  • Patients ≥ 18 years old.
  • Patients with ASA (American Society of Anesthesiologists) physical status 1 - 4.
  • Elective non-cardiac, non-obstetric, and non-gynaecologic surgery
  • Preoperative transthoracic echocardiography was performed within 48 hours before surgery. The values of Ees and Ea were determined by the method of Chen.
  • Patients consented to participate in the study.
  • Patients scheduled for surgery undergoing standard general anesthesia (protocol: see below) with endotracheal intubation.
  • Patients were hemodynamically stable until the preoperative period.

Exclusion Criteria:

• Uncorrected congenital heart disease, moderate-to-severe valvular disease or pulmonary hypertension, arrhythmias, anticipated difficult airway, and known allergy to anaesthetic agents.

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of Post-Induction Hypotension
Time Frame: From induction of anesthesia to surgical incision, up to 1 hour
Post-induction hypotension (PIH) was defined according to the protocol criteria and assessed during the interval from induction of anesthesia to surgical incision. The incidence of PIH was calculated as the number of analyzed participants who developed PIH during this interval.
From induction of anesthesia to surgical incision, up to 1 hour

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Area Under the Receiver Operating Characteristic Curve for Prediction of Post-Induction Hypotension
Time Frame: From induction of anesthesia to surgical incision, up to 1 hour
Predictive performance for post-induction hypotension (PIH) was evaluated using logistic regression models. Model discrimination was assessed using the area under the receiver operating characteristic curve (AUC). Clinical variables, echocardiographic measurements, and ventriculo-arterial coupling (VAC)-related variables were evaluated for prediction of PIH. Higher AUC values indicate better model discrimination.
From induction of anesthesia to surgical incision, up to 1 hour
Fractional New Information Added for Prediction of Post-Induction Hypotension
Time Frame: From induction of anesthesia to surgical incision, up to 1 hour
Incremental predictive value for post-induction hypotension (PIH) was assessed using fractional new information (FNI). FNI was used to quantify the additional predictive information provided by echocardiographic measurements and ventriculo-arterial coupling (VAC)-related variables when added to the clinical prediction model.
From induction of anesthesia to surgical incision, up to 1 hour

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Medical Center Ho Chi Minh City (UMC)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Khoi M Le, Assoc.Prof, University Medical Center

Publications and helpful links

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General Publications

Study record dates

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Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 3, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 20, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 10, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 24, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 1, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 32/GCN-HDDD
  • No: 32/GCN-HDDD (Other Identifier: University Medical Center Ho Chi Minh City)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Yes, there is a plan to make individual participant data (IPD) available. The de-identified dataset underlying the findings of this study will be shared upon reasonable request. Researchers can request access by contacting chinh.lh@umc.edu.vn. Requests will be reviewed to ensure compliance with ethical and legal standards.

IPD Sharing Time Frame

After publication of the study. Indefinitely

IPD Sharing Access Criteria

"Data will be shared upon reasonable request, with approval based on the researcher's qualifications and the purpose of the request." Access will only be granted to academic or non-commercial researchers who meet the conditions outlined in the Data Use Agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

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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