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

Sponsor
University Medical Center Ho Chi Minh City (UMC) (Other)
Overall Status
Recruiting
CT.gov ID
NCT05969886
Collaborator
(none)
335
1
12
28

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    335 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Predictive Value of Ventricular-Arterial Coupling for Post-Induction Hypotension: A Prospective Observational Cohort Study
    Actual Study Start Date :
    Jul 3, 2023
    Anticipated Primary Completion Date :
    Jul 1, 2024
    Anticipated Study Completion Date :
    Jul 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Prediction [from induction of anesthesia to incision initiation]

      Investigate the predictive value of the Ea/Ees ratio (along with echocardiographic variables) on PIH.

    Secondary Outcome Measures

    1. Incidence [from induction of anesthesia to incision initiation]

      Determine the frequency of PIH

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients ≥ 18 years old.

    • Patients with ASA (American Society of Anesthesiologists) physical status 1 - 4.

    • Elective 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:
    • Cardiac and obstetric surgery.

    • Allergy to any anesthetic drug.

    • Arrhythmia.

    • Severe valvular heart disease.

    • Severe pre-existing lung disease.

    • Mean pulmonary arterial pressure (PAPm ≥ 40 mmHg).

    • Anticipation of difficult airway management.

    • Hypotension occurs during the induction of anesthesia due to suspected anaphylaxis.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Medical Centre Ho Chi Minh Ho Chi Minh City Vietnam

    Sponsors and Collaborators

    • University Medical Center Ho Chi Minh City (UMC)

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Medical Center Ho Chi Minh City (UMC)
    ClinicalTrials.gov Identifier:
    NCT05969886
    Other Study ID Numbers:
    • 32/GCN-HDDD
    • No: 32/GCN-HDDD
    First Posted:
    Aug 1, 2023
    Last Update Posted:
    Aug 3, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Medical Center Ho Chi Minh City (UMC)
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 3, 2023