Echocardiographic Assessment of Volume Variation Secondary to Preoperative Fasting

Completed

• Conditions: Hypovolemia
• Interventions: Procedure: echocardiography

• Registration Number: NCT01258361
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

The primary objective of this study is to demonstrate that preoperative fasting does not increase the rate of lowered blood volume (defined by a variation of 15% ΔITV during a leg lift) in patients undergoing surgery.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-12-10
• Study First Submitted QC: 2010-12-10
• Study First Posted: 2010-12-13
• Study Start: 2011-01
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-25
• Last Update Posted: 2015-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• The patient must have given his/her informed and signed consent
• The patient must be insured or beneficiary of a health insurance plan
• The patient is ASA (American Society of Anesthesiologists) class I, II or III
• The patient has not been fasting for more than 6 hours at the time of inclusion
• The patient is schelduled for a gynecological or visceral surgery

Exclusion Criteria

• The patient is participating in another study
• The patient is in an exclusion period determined by a previous study
• The patient is under judicial protection, under tutorship or curatorship
• The patient refuses to sign the consent
• It is impossible to correctly inform the patient
• The patient is pregnant
• The patient is breastfeeding
• The patient is ASA class IV
• The patient has insulin dependent diabetes
• The patient has a cardiac or respiratory dysfunction
• The patient has a heart rhythm disorder
• The patient has renal insufficiency with dialysis
• The patient is being treated with diuretics
• The patient has had a bowel preparation
• Emergency surgery
• Outpatient surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
The study population	echocardiography	Patients will be recruited during anesthesia consultations carried out before programmed pelvic or visceral surgeries.

Primary Outcome Measures

Name	Time	Method
The presence / absence of a hypovolemia following preoperative fasting	1 day	Hypovolemia is determined by the % change in the subaortic velocity time integral during a leg lift before and after fasting: a 15% decrease is considered as a "presence".

Trial Locations

Locations (1)

Centre Hospitalier Universitaire de Nîmes; 🇫🇷 Nîmes, Gard, France