Accuracy of Gastric POCUS in Pediatric Trauma

The Sensitivity, Specificity and Predictive Accuracy of Gastric Point of Care Ultrasound in Pediatric Trauma Patients

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pediatric Trauma Patients

Detailed Description

Reflux aspiration of gastric contents is a critical concern in the perioperative setting, as it can result in severe complications such as aspiration pneumonia, acute respiratory distress syndrome, and even death. The risk is heightened during general anesthesia and is influenced by the quality and quantity of stomach contents. To mitigate this risk, the American Society of Anesthesiologists (ASA) recommends fasting guidelines prior to elective procedures. However, factors like trauma, acute and chronic pain, opioid use, and certain medical conditions can delay gastric emptying, complicating adherence to these guidelines.

Recent advancements in ultrasound techniques enable comprehensive evaluations of the nature and volume of gastric contents, making this tool convenient, noninvasive, and applicable at the bedside with minimal contraindications.The Perlas Model has been developed to identify surgical patients with "at-risk" stomachs, aiding in preoperative planning and airway management during general anesthesia. This model facilitates decisions regarding rapid sequence induction (RSI) and the choice of airway management techniques. However, there is a notable lack of research focusing on the use of ultrasound techniques in pediatric trauma patients to determine their diagnostic performance and predictive accuracy regarding gastric contents. Therefore, the aim of this study is to investigate the efficacy of POCUS in assessing the nature and volume of gastric contents in pediatric trauma patients undergoing urgent and semi-urgent surgical procedures.

• Study Type: Observational
• Enrollment (Estimated): 101

Contacts and Locations

• Study Contact: Name: Hala S Abdel-ghaffar; Phone Number: +201003812011; Email: hala_abdelghaffar@aun.edu.eg
• Study Contact Backup: Name: Youssef S Sayed; Phone Number: +201011689907; Email: mmryzh58581212@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Hala S Abdel-Ghaffar, Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: December 18, 2024
• First Submitted That Met QC Criteria: December 18, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 17, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: Gastric Pocus

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No