NCT06643325

Brief Summary

The investigators plan to do serial sonographic examinations of the gastric antrum (quantity, quality) to estimate the gastric emptying time and dependant factors after traumatic injurys.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2023

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

October 16, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

October 16, 2024

Status Verified

October 1, 2024

Enrollment Period

2.4 years

First QC Date

April 3, 2023

Last Update Submit

October 14, 2024

Conditions

AnesthesiaGastric UltrasoundSonographyPoint of Care Ultrasound (POCUS)RegurgitationPulmonary Aspiration During Anesthetic InductionTrauma Patients

Keywords

point of care ultrasoundgastric ultrasoundtrauma patientsaspirationanesthesia

Outcome Measures

Primary Outcomes (1)

  • Sonographic quality/quantity of the gastric antrum

    Quality of the gastric content (empty, fluid, solid or mixed fluid/solid) and quantity of the gastric content in ml, measured in 2 hour time intervals

    2 hour

Secondary Outcomes (3)

  • Pain-scale

    2 hour

  • Analgetics

    2 hour

  • Stress, activation of sympathic nerve system

    2 hour

Interventions

Gastric ultrasoundDIAGNOSTIC_TEST

Serial, gastric sonography

Eligibility Criteria

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

patients admitted to the emergency department with a relevant traumatic injury

You may qualify if:

  • relevant traumatic injury

You may not qualify if:

  • life-threatening traumatic injury (immediate treatment is necessary)
  • Underage
  • Known pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kantonsspital Winterthur

Winterthur, 8401, Switzerland

RECRUITING

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2023

First Posted

October 16, 2024

Study Start

February 1, 2023

Primary Completion

June 30, 2025

Study Completion

September 30, 2025

Last Updated

October 16, 2024

Record last verified: 2024-10

Locations

CH(1)