Echocardiographic Assessment of Volume Variation Secondary to Preoperative Fasting

Hypovolemia Clinical Trial

Official title:

Echocardiographic Assessment of Volume Variation Secondary to Preoperative Fasting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01258361
• Other study ID #: LOCAL/2010/LM-03
• Secondary ID: 2010-A01275-34
• Status: Completed
• Phase: N/A
• First received: December 10, 2010
• Last updated: March 25, 2015
• Start date: January 2011
• Est. completion date: April 2011

Study information

• Verified date: March 2015
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of PersonnesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypovolemia

Intervention

Procedure:
• echocardiography
Echocardiography is performed for all patients

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Nîmes	Nîmes	Gard

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No