NCT04083677

Brief Summary

Pulmonary aspiration of gastric contents is uncommon in the elective, surgical populations, but highly prevalent in trauma patients who requires emergency surgery as trauma impair gastric motility and emptying.1 Presence of residual gastric volume at the time of anesthetic induction is an important risk of aspiration pneumonitis.2 Routine use of non-invasive bedside ultrasound gives information about the volume and nature of gastric volume. Determination of gastric content volume preoperatively will help the anesthetist in the assessment of pulmonary aspiration risk 3, 4 Ultrasongraphic measurment of antral CSA (cross sectional area) can diagnose risk stomach during the preoperative period defined by a gastric volume at risk of pulmonary aspiration (ie presence of Solid particles and/or gastric volume \>1.5 ml/kg)5 The aim of our study is to allow routine use of point of care ultrasound (pocus) of gastric contents in order to inform an assessment of aspiration risk and guide anesthetic mangment

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 2019

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

September 6, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 10, 2019

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2019

Completed
Last Updated

November 25, 2019

Status Verified

November 1, 2019

Enrollment Period

1 month

First QC Date

September 6, 2019

Last Update Submit

November 21, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • gastric content

    gastric content volume by sonar

    6 months

Study Arms (2)

Control GROUP

healthy adult fasting 8 hours before the operation sonographic examination of gastric antrum before anesthesia

Device: SONAR

trauma GROUP

trauma patients fasting 8 hours before the operation sonographic examination of gastric antrum before anesthesia

Device: SONAR

Interventions

SONARDEVICE

A curved low- frequency (2-5 MHZ) probe and (simens ACUSON x 300) ultrasound system will be used. All patient will be first scanned in the supine position, followed by the right lateral decubitus (RLD) position. The gastric antrum was identified in a sagittal scanning plane in the epigastrium immediately inferior to xiphoid and superior to umbilicus. The liver anteriorly and the aorta, inferior vena cava and pancreas posteriorly were used as anatomical reference points.

Control GROUPtrauma GROUP

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study included forty five polytrauma patients (18-65 years old of both sexes) admitted for emergency surgery.

You may qualify if:

  • polytrauma patients admitted for emergency surgery.

You may not qualify if:

  • patients with obesity (BMI\> 35kg/m2),
  • pregnancy,
  • a history of upper gastrointestinal diseases including gastroesophageal reflux disease, hiatus hernia, gastroeosphgeal cancer or upper GIT surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ramymahrose

Cairo, 02, Egypt

Location

Related Publications (1)

  • Shorbagy MS, Kasem AA, Gamal Eldin AA, Mahrose R. Routine point-of-care ultrasound (POCUS) assessment of gastric antral content in traumatic emergency surgical patients for prevention of aspiration pneumonitis: an observational clinical trial. BMC Anesthesiol. 2021 May 8;21(1):140. doi: 10.1186/s12871-021-01357-y.

Study Officials

  • ramy mahrose, md

    asuh

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of anesthesia at faculty of medicine ain shams university

Study Record Dates

First Submitted

September 6, 2019

First Posted

September 10, 2019

Study Start

September 1, 2019

Primary Completion

October 1, 2019

Study Completion

November 30, 2019

Last Updated

November 25, 2019

Record last verified: 2019-11

Locations