NCT02386787

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 12, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

May 25, 2016

Status Verified

March 1, 2016

Enrollment Period

1.8 years

First QC Date

February 20, 2015

Last Update Submit

May 24, 2016

Conditions

AnesthesiaSurgical Procedure, Unspecified

Keywords

UltrasonographyNon-elective surgeryAnesthesia

Outcome Measures

Primary Outcomes (1)

  • patients with full stomach

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

    baseline

Secondary Outcomes (7)

  • duration of preoperative fasting

    baseline

  • type of surgery disease

    baseline

  • preoperative pain

    baseline

  • feeling of hunger

    baseline

  • nausea and vomiting

    baseline

  • +2 more secondary outcomes

Study Arms (1)

SEMI EMERGENCY SURGERY PATIENT

EXPERIMENTAL

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

Device: Ultrasonography

Interventions

UltrasonographyDEVICE

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

SEMI EMERGENCY SURGERY PATIENT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu de Saint Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Julie GAVORY, MD

    CHU de Saint Etienne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2015

First Posted

March 12, 2015

Study Start

May 1, 2014

Primary Completion

March 1, 2016

Study Completion

April 1, 2016

Last Updated

May 25, 2016

Record last verified: 2016-03

Locations

FR(1)