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Completed

NCT Number: NCT01258361

Echocardiographic Assessment of Volume Variation Secondary to Preoperative Fasting

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Universitaire de Nîmes

Nîmes, Gard, 30029, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Echocardiography

Procedure

Echocardiography is performed for all patients

Primary outcomes

  1. The presence / absence of a hypovolemia following preoperative fasting

    Time frame: 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".

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Dec 13, 2010
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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