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

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

Completed

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

Observational

Enrollment (Actual)

475

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

      • 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

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

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

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.

Investigators

  • Study Director: Khoi M Le, Assoc.Prof, University Medical Center

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.

General Publications

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)

July 3, 2023

Primary Completion (Actual)

November 20, 2024

Study Completion (Actual)

December 10, 2024

Study Registration Dates

First Submitted

July 24, 2023

First Submitted That Met QC Criteria

July 24, 2023

First Posted (Actual)

August 1, 2023

Study Record Updates

Last Update Posted (Actual)

September 15, 2026

Last Update Submitted That Met QC Criteria

September 13, 2026

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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