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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Centre Hospitalier Universitaire de Nīmes

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 September 18, 2014