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NCT Number: NCT06747403

Accuracy of Gastric POCUS in Pediatric Trauma

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.

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Key information

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Accuracy of gastric POCUS

    Time frame: 1 hour from performing gastric POCUS till performing operative procedures

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hala S Abdel-ghaffar

CONTACT

[email protected]

+201003812011

Youssef S Sayed

CONTACT

[email protected]

+201011689907

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 24, 2024
Registry last updated
Jan 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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