Echocardiographic Assessment of Volume Variation Secondary to Preoperative Fasting

NCT01258361 | Completed

• 2 other identifiers: LOCAL/2010/LM-032010-A01275-34
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypovolemia

Keywords

preoperative fasting

Outcome Measures

Primary Outcomes (1)

• The presence / absence of a hypovolemia following preoperative fasting

  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".

  1 day

Study Arms (1)

The study population

Patients will be recruited during anesthesia consultations carried out before programmed pelvic or visceral surgeries.

Procedure: echocardiography

Interventions

echocardiography PROCEDURE

Echocardiography is performed for all patients

The study population

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients recruited during anesthesia consultations carried out before programmed gynecological or visceral surgeries.

You may qualify if:

• 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 is schelduled for a gynecological or visceral surgery

You may not qualify if:

• The patient is participating in another 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

Centre Hospitalier Universitaire de Nîmes

Nîmes, Gard, 30029, France

Location

Related Publications (1)

• Muller L, Briere M, Bastide S, Roger C, Zoric L, Seni G, de La Coussaye JE, Ripart J, Lefrant JY. Preoperative fasting does not affect haemodynamic status: a prospective, non-inferiority, echocardiography study. Br J Anaesth. 2014 May;112(5):835-41. doi: 10.1093/bja/aet478. Epub 2014 Feb 3.

  PMID: 24496782 RESULT

MeSH Terms

Conditions

Hypovolemia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Laurent Muller, MD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2010
• First Posted: December 13, 2010
• Study Start: January 1, 2011
• Primary Completion: April 13, 2011
• Study Completion: April 13, 2011
• Last Updated: November 17, 2025

Record last verified: 2015-03

Locations

FR (1)