Gastric Emptying Time in Traumatic Injuries | NCT06643325

Studies
Gastric Emptying Time in Traumatic Injuries

NCT06643325

Sponsor

Kantonsspital Winterthur KSW

Status

Recruiting

Last Update Posted

Oct 16, 2024Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Anesthesia
Gastric Ultrasound
Sonography
Point of Care Ultrasound (POCUS)
Regurgitation
Pulmonary Aspiration During Anesthetic Induction
Trauma Patients

Interventions

Gastric ultrasound

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2023Actual

Primary Completion Date

Jun 30, 2025Estimated

Completion Date

Sep 30, 2025Estimated

First Submitted Date

Apr 3, 2023

First Submission Date that Met QC Criteria

Oct 14, 2024

First Posted Date

Oct 16, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 14, 2024

Last Update Posted Date

Oct 16, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

The investigators plan to do serial sonographic examinations of the gastric antrum (quantity, quality) in patients suffering from a relevant traumatic injury. Patients which are admitted to the emergency department with a corresponding history are considered for inclusion. Patient with life-threatening injuries are excluded. After inclusion, the investigators plan to carry out gastric ultrasound (POCUS) all 2 hours until the operative treatment (maximal 5 examinations). To identify factors which may be correlated with delayed gastric emptying several demographic and patient related factors are collected.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Name	Type	Description	Arm Group Labels	Other Names
Gastric ultrasound	Diagnostic Test	Serial, gastric sonography

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Pain-scale	Evaluate pain using the VAS Scale 0-10 (Visual Analog Scale)	2 hour
Analgetics	Evaluate need of analgetics	2 hour

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

relevant traumatic injury

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients admitted to the emergency department with a relevant traumatic injury

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kantonsspital Winterthur	Recruiting	Winterthur		8401	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005764	Gastroesophageal Reflux

Ancestor Terms

ID	Term
D015154	Esophageal Motility Disorders
D003680	Deglutition Disorders
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided