Echocardiographic Assessment of Volume Variation Secondary to Preoperative Fasting

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01258361
First received: December 10, 2010
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

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 Intervention
Hypovolemia
Procedure: echocardiography

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Echocardiographic Assessment of Volume Variation Secondary to Preoperative Fasting

Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • The presence / absence of a hypovolemia following preoperative fasting [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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".


Enrollment: 100
Study Start Date: January 2011
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01258361

Locations
France
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
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01258361     History of Changes
Other Study ID Numbers: LOCAL/2010/LM-03, 2010-A01275-34
Study First Received: December 10, 2010
Last Updated: March 3, 2014
Health Authority: France: Committee for the Protection of Personnes
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Hospitalier Universitaire de Nīmes:
preoperative fasting

Additional relevant MeSH terms:
Hypovolemia
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014