NCT06747403

Brief Summary

The goal of this observational study is to detect the predictive accuracy of the gastric POCUS in pediatric trauma patients undergoing urgent and semi urgent operative procedures. The main question it aims to answer is : What is the predictive value of the gastric POCUS in pediatric patients? Participants are pediatric patients who will be scheduled for operative procedures within one hour of performing gastric POCUS.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
101

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2025

Shorter than P25 for all trials

Status
not yet 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

First Submitted

Initial submission to the registry

December 18, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 24, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

January 20, 2025

Status Verified

January 1, 2025

Enrollment Period

10 months

First QC Date

December 18, 2024

Last Update Submit

January 17, 2025

Conditions

Pediatric Trauma Patients

Outcome Measures

Primary Outcomes (1)

  • Accuracy of gastric POCUS

    We will investigate the diagnostic performance and predictive accuracy of the gastric POCUS in pediatric trauma patients undergoing urgent and semi urgent operative procedures as our primary outcome of interest. The sensitivity, specificity, positive predictive value and negative predictive value will be assessed using the Receiver Operating Characteristics (ROC) curve.

    1 hour from performing gastric POCUS till performing operative procedures

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

This study will be conducted in the emergency departments in Assiut and Suez Canal University hospitals after its approval from the ethical committees.

You may qualify if:

  • Pediatric patients who will be scheduled for operative procedures within an hour of performing gastric POCUS.
  • Age group 1-18 years
  • ASA Physical status (I-III).
  • Both gender

You may not qualify if:

  • Children with known abnormal upper GIT anatomy or prior upper GIT surgery.
  • Children with wounds of the epigastrium precluding probe placement.
  • Children deemed unable to tolerate the US probe

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Hala S Abdel-Ghaffar

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hala S Abdel-ghaffar

CONTACT

+201003812011hala_abdelghaffar@aun.edu.eg

Youssef S Sayed

CONTACT

+201011689907mmryzh58581212@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 18, 2024

First Posted

December 24, 2024

Study Start

March 1, 2025

Primary Completion

January 1, 2026

Study Completion

March 1, 2026

Last Updated

January 20, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share