Clinical trial NCT06747403: Accuracy of Gastric POCUS in Pediatric Trauma
Official title: The Sensitivity, Specificity and Predictive Accuracy of Gastric Point of Care Ultrasound in Pediatric Trauma Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pediatric Trauma Patients
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-12-24
Enrollment: 101
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Accuracy of gastric POCUS
timeFrame: 1 hour from performing gastric POCUS till performing operative procedures
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Hala S Abdel-Ghaffar
role: PRINCIPAL_INVESTIGATOR
References: