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Preoperative Blood Volume Optimization Using Transthoracic Echocardiography

NCT06639737 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2024-10-15

No results posted yet for this study

Summary

Immediately following the induction of general anesthesia, arterial hypotension may occur with an incidence of about 40% in patients classified as ASA 3 or 4. Perioperative arterial hypotension is associated with increased perioperative morbidity and mortality. The increased mortality associated with perioperative arterial hypotension has been reported up to 30 and 90 days after surgery. This association appears to be both dose-dependent and time-dependent (severity and duration of arterial hypotension).

EchOptimal study aims to determine whether non invasive preoperative stroke volume optimization using transthoracic echocardiography (TTE) can reduce the incidence and severity arterial hypotension following induction of general anesthesia.

This is prospective, randomized, controlled, double blinded study approved by ethics comittee.

The primary objective of this study is to compare the incidence of arterial hypotension (mean arterial pressure \< 65 mmHg) within the first 15 minutes following the induction of general anesthesia, between 2 groups :

* standard current care (stroke volume optimized after induction of general anesthesia using oesophageal doppler) and
* preopertaive stroke volume optimization using transthoracic echocardiography measument of subaortic velocity time integral.

Conditions

  • Anesthesia
  • Anesthesia Complication
  • Anesthesia Induction
  • Arterial Hypotension

Interventions

PROCEDURE

preoperative stroke volume optimization

Stroke volume optimization using transthoracic echocardigraphy (sub aortic velocity time integral) before induction of total intravenous anesthesia. Fluids bolus of 250 ml of cristalloids will be successively administered until the sub aortic velocity time integral increase will be \< 10%

PROCEDURE

Post induction stroke volume optimization

Optimization of stroke volume following induction of general anesthesia using oesophageal stroke volume measurement. 250 ml bolus of cristalloids succesively administered until the stroke volume increase \<10%

Sponsors & Collaborators

  • University Hospital, Caen

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-04
Primary Completion
2026-12-30
Completion
2027-12-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06639737 on ClinicalTrials.gov