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Ultrasound Assessment of Gastric Content Before Anesthesia for Appendectomy (EGASTA)

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ClinicalTrials.gov Identifier: NCT02983175
Recruitment Status : Unknown
Verified December 2016 by Central Hospital, Nancy, France.
Recruitment status was:  Not yet recruiting
First Posted : December 6, 2016
Last Update Posted : December 6, 2016
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

Brief Summary:

Performing anesthetic induction for appendicectomy has two main risks : first aspiraion of gastric content causing pneumonia. Otherwise, anaphylactic risk to drugs used during anesthetic induction. Indeed, the guidelines recommend an anesthetic induction protocol qualified "full stomach" whatever the patient and the preoperative fasting period are. This protocol provides the use of fast-acting neuromuscular blocking agents (succinylcholine or rocuronium). However, these neuromuscular blocking agents are ten times more at allergic risk than others. Ultrasound assessment of gastric content before rapid sequence induction of anesthesia is a reproducible, non-invasive, inexpensive and quickly achievable bedside technique. Furthermore, the correlations between gastric volume and risk of a full stomach and also between the cross-section antral area (CSA) and the risk of a full stomach have been validated on several patient cohorts. We formulate the hypothesis that the achievement of a gastric ultrasound before anesthetic induction for appendectomy could allow to identify "full stomach" patients who actually justify rapid sequence induction of anesthesia with exposure to fast-acting neuromuscular blocking agents that implies.

Primary endpoint is to determine te percentage of patients who have a gastric content before appendectomy. Secondary endpoint is to determine the incidenc of aspiration pneumonia and anaphylactic shock. Another secondary endpoint is to determine the percentage of patient with gastric content with the antral grading system (Perlas method) and to evaluate the concordance between this methode and the cross-section antral area.


Condition or disease Intervention/treatment Phase
Appendectomy Other: ultrasound assessment of gastric content Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Ultrasound Assessment of Gastric Content and Gastric Volume Before Crash Induction for Appendectomy
Study Start Date : December 2016
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ultrasound assessment of gastric content Other: ultrasound assessment of gastric content

Achievement of gastric ultrasound (specific procedure) :

Gastric ultrasound is performed specifically for the study by a senior anesthetist physician in a patient placed supine, semi-sitting by an angle of 45 ° relative to the horizontal.

Standardised achievement of the antral ultrasound by the following method:

  • First, a qualitative assessment of antral contents in 3 grades according to the "Perlas" method [24].
  • Second, performing a quantitative analysis of antral contents calculating the CSA.
  • Then, volume of gastric contents calculation as from the CSA.




Primary Outcome Measures :
  1. Cross-section antral area (CSA) [ Time Frame: baseline J0 ]
    Ultrasonography exam of the stomach is used to evaluate the CSA. A CSA greater than 340mm² defines a full stomach. The calculation of the CSA is : CSA = AP x CC x π / 4 (in mm²). With AP - antero-posterior gastric antrum diameter and CC - cranio-caudal gastric antrum diameter



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient admitted to the operating room for appendectomy.
  • Major or minor patient (higher than 16) affiliated to a social security scheme.
  • Patient or parents of minor patient who received the full information relative to the organization of the study and who signed his/their informed consent(s).

Exclusion Criteria:

  • Pregnant women.
  • Childbearing age patient does not have effective contraception.
  • Breastfeeding woman.
  • Minor patient under 16.
  • Major patient subject to a measure of legal protection or unable to consent.
  • Persons deprived of liberty by a judicial or an administrative decision.
  • Patient with gastric and/or esophagus surgery history.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02983175


Contacts
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Contact: Marie-Alix REGNIER-KIMMOUN, PH 03.83.85.14.03 ext +33 ma.regnier@chru-nancy.fr

Sponsors and Collaborators
Central Hospital, Nancy, France