Echocardiographic Assessment of Volume Variation Secondary to Preoperative Fasting

• Sponsor: Centre Hospitalier Universitaire de Nīmes (Other)
• Overall Status: Completed
• CT.gov ID: NCT01258361
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Duration (Months): 3
• Patients Per Site Per Month: 33.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypovolemia	Procedure: echocardiography

Study Design

• Study Type: Observational
• Actual Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Echocardiographic Assessment of Volume Variation Secondary to Preoperative Fasting
• Study Start Date: Jan 1, 2011
• Actual Primary Completion Date: Apr 1, 2011
• Actual Study Completion Date: Apr 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
The study population Patients will be recruited during anesthesia consultations carried out before programmed pelvic or visceral surgeries.	Procedure: echocardiography; Echocardiography is performed for all patients

Outcome Measures

Primary Outcome Measures

1. 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".

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Hospitalier Universitaire de Nîmes	Nîmes	Gard	France	30029

Sponsors and Collaborators

• Centre Hospitalier Universitaire de Nīmes

Investigators

• Principal Investigator: Laurent Muller, MD, Centre Hospitalier Universitaire de Nîmes

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire de Nīmes
• ClinicalTrials.gov Identifier: NCT01258361
• Other Study ID Numbers: LOCAL/2010/LM-03; 2010-A01275-34
• First Posted: Dec 13, 2010
• Last Update Posted: Mar 26, 2015
• Last Verified: Mar 1, 2015

• Keywords provided by Centre Hospitalier Universitaire de Nīmes: preoperative fasting
• Additional relevant MeSH terms: Hypovolemia

Study Results

No Results Posted as of Mar 26, 2015