Dynamic Arterial Elastance During General Anesthesia Induction

Dynamic Arterial Elastance as Predictive Parameter of Hypotension During General Anesthesia Induction.

This study evaluates if dynamic arterial elastance measured before general anesthesia induction can predict the occurrence of hypotension due to general anesthesia induction.

Study Overview

• Status: Unknown
• Conditions: Anesthesia

Detailed Description

As general anesthetics may be responsible for vasodilation and cardiac depression, arterial hypotension after induction of general anesthesia is a common event and may contribute to an adverse outcome. Dynamic arterial elastance has been proposed as a functional parameter of arterial tone and studies showed that it was able to predict pressure response to fluid administration in fluid-responsive patients and the amount of mean arterial pressure riduction as a conseguence of noradrenaline dose reduction in critically ill patients.

• Study Type: Observational
• Enrollment (Anticipated): 65

Contacts and Locations

Study Locations

• Italy
  • Ancona, Italy
    • Recruiting
    • Azienda Ospedaliero Universitaria Ospedali Riuniti Ancona
    • Contact: Abele Donati, MD, PhD; Phone Number: +390715964603; Email: a.donati@univpm.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients undergone to general anesthesia for surgery that need mini-invasive cardiac output monitoring.

Description

Inclusion Criteria:

• Patients that will be undergone to general anesthesia for surgery
• Patients that need mini-invasive cardiac output monitoring during surgery

Exclusion Criteria:

• Age <18 yo
• Pregnancy
• Arrhythmia
• Severe valvular diseases
• Uncorrectable alterations of arterial signal

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baseline value of Eadyn as predictor of hypotension occurrence due to general anesthesia induction	Dynamic arterial elastance (Eadyn) will be recorded at baseline before induction of general anesthesia. Mean arterial pressure (MAP) will be recorded at baseline and continuously until tracheal intubation. The lowest value of MAP will be considered to define hypotension occurrence.	From baseline (before general anesthesia induction) up to 30 minutes.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between Eadyn and severity of hypotension due to anesthesia induction	To evaluate the correlation between the baseline value of Eadyn and the severity of hypotension when it will occur after induction of general anesthesia	From baseline (before general anesthesia induction) up to 30 minutes.

Collaborators and Investigators

• Sponsor: Università Politecnica delle Marche
• Investigators: Principal Investigator: Abele Donati, MD, PhD, Università Politecnica delle Marche

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2019
• Primary Completion (Anticipated): July 1, 2020
• Study Completion (Anticipated): April 1, 2021

Study Registration Dates

• First Submitted: April 4, 2019
• First Submitted That Met QC Criteria: April 8, 2019
• First Posted (Actual): April 10, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2020
• Last Update Submitted That Met QC Criteria: March 23, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: CLRIA-AC01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No