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OpenTrials
Completed

NCT Number: NCT02386787

Ultrasound Assessment of Gastric Content for Semi Emergency Surgery

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.

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Key information

Conditions

Anesthesia Surgical Procedure, Unspecified

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu de Saint Etienne

Saint-Etienne, 42055, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ultrasonography

Device

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

Primary outcomes

  1. patients with full stomach

    Time frame: baseline

    Full stomach is defined by an antral cross-section area (CSA) > 410 mm2, measured by ultrasonography

Secondary outcomes

  1. duration of preoperative fasting

    Time frame: baseline

  2. type of surgery disease

    Time frame: baseline

  3. preoperative pain

    Time frame: baseline

    Visual Analog Scale

  4. feeling of hunger

    Time frame: baseline

  5. nausea and vomiting

    Time frame: baseline

    number of patients with nausea and vomiting

  6. type of anesthetic procedure performed

    Time frame: baseline

    rapid or standard anesthetic induction

  7. inhalation of gastric contents

    Time frame: baseline

    number of patients with inhalation of gastric contents during intervention

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Acronym: ECHO-GAST

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Mar 12, 2015
Registry last updated
May 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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