Ultrasound Assessment of Gastric Content for Semi Emergency Surgery

NCT ID: NCT02386787

Last Updated: 2016-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2016-04-30

Brief Summary

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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

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Conditions

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Anesthesia Surgical Procedure, Unspecified

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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SEMI EMERGENCY SURGERY PATIENT

patient undergoing a non-elective surgery and having a preoperative fasting period of six hours.

Group Type EXPERIMENTAL

Ultrasonography

Intervention Type DEVICE

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

Interventions

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Ultrasonography

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Julie GAVORY, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de Saint Etienne

Locations

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Chu de Saint Etienne

Saint-Etienne, , France

Site Status

Countries

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France

Other Identifiers

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2013-A01649-36

Identifier Type: OTHER

Identifier Source: secondary_id

1308170

Identifier Type: -

Identifier Source: org_study_id

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