Ultrasound Assessment of Gastric Content Before Anesthesia for Appendectomy

Not Applicable

• Conditions: Appendectomy
• Interventions: Other: ultrasound assessment of gastric content

• Registration Number: NCT02983175
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-12
• Study Start: 2016-12
• Study First Submitted: 2016-12-02
• Study First Submitted QC: 2016-12-05
• Last Update Submitted: 2016-12-05
• Study First Posted: 2016-12-06
• Last Update Posted: 2016-12-06
• Primary Completion: 2017-08
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ultrasound assessment of gastric content	ultrasound assessment of gastric content	-

Primary Outcome Measures

Name	Time	Method
Cross-section antral area (CSA)	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