Echocardiographic Assessment of Volume Variation Secondary to Preoperative Fasting

NCT ID: NCT01258361

Last Updated: 2025-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-04-13

Brief Summary

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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.

Detailed Description

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Conditions

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Hypovolemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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The study population

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

echocardiography

Intervention Type PROCEDURE

Echocardiography is performed for all patients

Interventions

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echocardiography

Echocardiography is performed for all patients

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laurent Muller, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Locations

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Centre Hospitalier Universitaire de Nîmes

Nîmes, Gard, France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 24496782 (View on PubMed)

Other Identifiers

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2010-A01275-34

Identifier Type: OTHER

Identifier Source: secondary_id

LOCAL/2010/LM-03

Identifier Type: -

Identifier Source: org_study_id

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