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NCT Number: NCT05969886

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Centre Ho Chi Minh

Ho Chi Minh City, Vietnam

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

University Medical Center Ho Chi Minh City (UMC)

Other

Registry information

Official study title

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

Acronym: VAC

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 1, 2023
Registry last updated
Sep 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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