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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


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
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