Clinical trial NCT05648643: Arterial Elastance: A Predictor of Hypotension Due to Anesthesia Induction
Official title: Arterial Elastance: A Predictor of Hypotension Due to Anesthesia Induction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemodynamic Instability
Anesthesia
Keywords: General anesthesia
Arterial elastance
Post-induction hypotension
Monitorization
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2022-12-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with ASA physical status 1-3 who underwent major elective surgery

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Arterial elastance (Ea) measured before anesthesia induction was investigated whether is a predictive parameter for post-induction hypotension in patients undergoing general anesthesia.
timeFrame: The duration of the study was defined from one minute before induction to 10 minutes after induction
Secondary outcomes:
measure: Stroke volume variation (SVV), measured before anesthesia induction were assessed for prediction of post-induction hypotension in patients undergoing general anesthesia
timeFrame: The duration of the study was defined from one minute before induction to 10 minutes after induction
Other outcomes:
measure: Pulse pressure variation (PPV), measured before anesthesia induction were assessed for prediction of post-induction hypotension in patients undergoing general anesthesia
timeFrame: The duration of the study was defined from one minute before induction to 10 minutes after induction
measure: Cardiac power output (CPO), measured before anesthesia induction were assessed for prediction of post-induction hypotension in patients undergoing general anesthesia
timeFrame: The duration of the study was defined from one minute before induction to 10 minutes after induction
measure: Cardiac index (CI), measured before anesthesia induction were assessed for prediction of post-induction hypotension in patients undergoing general anesthesia
timeFrame: The duration of the study was defined from one minute before induction to 10 minutes after induction
measure: Dp/Dt, measured before anesthesia induction were assessed for prediction of post-induction hypotension in patients undergoing general anesthesia
timeFrame: The duration of the study was defined from one minute before induction to 10 minutes after induction
measure: Systolic arterial pressure (SAP), measured before anesthesia induction were assessed for prediction of post-induction hypotension in patients undergoing general anesthesia
timeFrame: The duration of the study was defined from one minute before induction to 10 minutes after induction
measure: diastolic arterial pressure (DAP), measured before anesthesia induction were assessed for prediction of post-induction hypotension in patients undergoing general anesthesia
timeFrame: The duration of the study was defined from one minute before induction to 10 minutes after induction
measure: mean arterial pressure (MAP), measured before anesthesia induction were assessed for prediction of post-induction hypotension in patients undergoing general anesthesia
timeFrame: The duration of the study was defined from one minute before induction to 10 minutes after induction
measure: Heart rate (HR), measured before anesthesia induction were assessed for prediction of post-induction hypotension in patients undergoing general anesthesia
timeFrame: The duration of the study was defined from one minute before induction to 10 minutes after induction
Locations:
city: Istanbul
country: Turkey
facility: Acibadem Altunizade Hospital
Study officials:
References:
citation: Monge Garcia MI, Jian Z, Settels JJ, Hatib F, Cecconi M, Pinsky MR. Reliability of effective arterial elastance using peripheral arterial pressure as surrogate for left ventricular end-systolic pressure. J Clin Monit Comput. 2019 Oct;33(5):803-813. doi: 10.1007/s10877-018-0236-y. Epub 2018 Dec 14.
citation: Merillon JP, Ennezat PV, Guiomard A, Masquet-Gourgon C, Aumont MC, Gourgon R. Left ventricular performance is closely related to the physical properties of the arterial system: Landmark clinical investigations in the 1970s and 1980s. Arch Cardiovasc Dis. 2014 Oct;107(10):554-62. doi: 10.1016/j.acvd.2014.08.001. Epub 2014 Oct 8.
citation: Monge Garcia MI, Jian Z, Settels JJ, Hunley C, Cecconi M, Hatib F, Pinsky MR. Determinants of left ventricular ejection fraction and a novel method to improve its assessment of myocardial contractility. Ann Intensive Care. 2019 Apr 16;9(1):48. doi: 10.1186/s13613-019-0526-7.