Ultrasound Assessment of Gastric Content for Semi Emergency Surgery

Anesthesia Clinical Trial

— ECHO-GAST  

Official title:

Ultrasound Assessment of Gastric Content for Semi Emergency Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02386787
• Other study ID #: 1308170
• Secondary ID: 2013-A01649-36
• Status: Completed
• Phase: N/A
• First received: February 20, 2015
• Last updated: May 24, 2016
• Start date: May 2014
• Est. completion date: April 2016

Study information

• Verified date: March 2016
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: French Data Protection Authority
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: April 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Anesthesia
• Surgical Procedure, Unspecified

Intervention

Device:
• Ultrasonography
an ultrasonography will be conducted before the anesthesic procedure to provide reliable quantitative information about the volume of gastric content.

Locations

Country	Name	City	State
France	Chu de Saint Etienne	Saint Etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	patients with full stomach	Full stomach is defined by an antral cross-section area (CSA) > 410 mm2, measured by ultrasonography	baseline	No
Secondary	duration of preoperative fasting		baseline	No
Secondary	type of surgery disease		baseline	No
Secondary	preoperative pain	Visual Analog Scale	baseline	No
Secondary	feeling of hunger		baseline	No
Secondary	nausea and vomiting	number of patients with nausea and vomiting	baseline	No
Secondary	type of anesthetic procedure performed	rapid or standard anesthetic induction	baseline	No
Secondary	inhalation of gastric contents	number of patients with inhalation of gastric contents during intervention	baseline	No