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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03910179
Other study ID # CLRIA-AC01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 10, 2019
Est. completion date April 2021

Study information

Verified date March 2020
Source Università Politecnica delle Marche
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 65
Est. completion date April 2021
Est. primary completion date July 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Italy Azienda ospedaliero Universitaria Ospedali Riuniti Ancona Ancona

Sponsors (1)

Lead Sponsor Collaborator
Università Politecnica delle Marche

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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.
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