Ultrasound Assessment of Gastric Content for Semi Emergency Surgery

Not Applicable

Completed

• Conditions: Surgical Procedure, Unspecified; Anesthesia
• Interventions: Device: Ultrasonography

• Registration Number: NCT02386787
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

Aspiration of gastric content is a rare but serious complication of anesthesia. In this context, preoperative fasting for elective surgery is well defined. In an emergency situation, international guidelines recommend rapid sequence of anesthesia to reduce the risk of aspiration. In semi emergency situation, there is no consensus about the anesthetic procedure even if a preoperative fasting has been observed due to uncertainty of gastric emptying related to stress or painful condition. The choice of anesthesia induction technique depends mainly on the anesthetist. Ultrasonography is a non invasive bedside tool that can provide reliable quantitative information about the volume of gastric content.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2015-02-20
• Study First Submitted QC: 2015-03-11
• Study First Posted: 2015-03-12
• Status Verified: 2016-03
• Primary Completion: 2016-03
• Study Completion: 2016-04
• Last Update Submitted: 2016-05-24
• Last Update Posted: 2016-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• undergoing a non-elective surgery
• having a preoperative fasting period of six hours

Exclusion Criteria

• patients with digestive diseases (gastroesophageal reflux disease, hiatal hernia, active peptic ulcer, upper gastrointestinal bleeding, vagal denervation, pyloric stenosis, extrinsic digestive compression, occlusive syndrome), neurologic diseases (spinal cord injury over T10, amylose, Shy-Drager syndrome)
• patients with full stomach (preoperative fasting under 6 hours),
• pregnant women (over 15 weeks of amenorrhea)
• patients who received premedication.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SEMI EMERGENCY SURGERY PATIENT	Ultrasonography	patient undergoing a non-elective surgery and having a preoperative fasting period of six hours.

Primary Outcome Measures

Name	Time	Method
patients with full stomach	baseline	Full stomach is defined by an antral cross-section area (CSA) \> 410 mm2, measured by ultrasonography

Secondary Outcome Measures

Name	Time	Method
feeling of hunger	baseline
duration of preoperative fasting	baseline
type of surgery disease	baseline
preoperative pain	baseline	Visual Analog Scale
inhalation of gastric contents	baseline	number of patients with inhalation of gastric contents during intervention
nausea and vomiting	baseline	number of patients with nausea and vomiting
type of anesthetic procedure performed	baseline	rapid or standard anesthetic induction

Trial Locations

Locations (1)

Chu de Saint Etienne; 🇫🇷 Saint Etienne, France