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NCT05330351 · ClinicalTrials.gov registry record
Gastric Ultrasound in Pediatric Trauma Patients
A clinical trial of Aspiration and Trauma; Complications, sponsored by Children's Hospital of Philadelphia.
- Active
- Registry status
- 40
- Enrollment target
- 1
- Study location
NCT05330351: Active study of Aspiration and Trauma; Complications, sponsored by Children's Hospital of Philadelphia.
NCT05330351 is a study of Aspiration and Trauma; Complications that is active but no longer recruiting, run by Children's Hospital of Philadelphia. The registered enrollment target is 40 participants, below the 291-participant average among 4 other Aspiration trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05330351, a study of Aspiration and Trauma; Complications, is active but no longer recruiting, sponsored by Children's Hospital of Philadelphia.
- ACTIVE NOT RECRUITING
- Registry status
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
Gastric ultrasound has become increasingly utilized to examine volume and quality of gastric contents in the preoperative setting to guide anesthetic management and relay risk of aspiration in both adult and pediatric medicine. Gastric fluid volumes in trauma patients are thought to be elevated due to delayed gastric emptying in the setting of an over-attenuated sympathetic response to physical pain and stress, opioid analgesia, and other associated injuries (traumatic brain). However, there is a paucity of literature examining gastric fluid volumes (GFV), measured by gastric ultrasound, in the pediatric trauma population. The purpose of the study is to assess whether preoperative gastric ultrasound is an accurate method to identify pediatric trauma patients who have elevated GFV (\>0.8mL/kg) and high-risk gastric contents (solids, complex liquids, in addition to large volumes).
Primary Outcome
GFV will be estimated via obtained gastric antral cross-sectional area (CSA), measured by ultrasound, and calculated using the formula: GSV= 0.0093 \* CSA \[mm2\] - 0.96. This calculated GFV will be compared to aspirated gastric volumes.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Gastric Ultrasound
Study Locations (1)
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2022-03-26 |
| Est. Completion | 2026-12-31 |
What the registry record for NCT05330351 still lists
NCT05330351 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 291-participant average among 4 other Aspiration trials with a reported enrollment target (86% lower).
The record links to 2 conditions, with Aspiration appearing as the primary indexed condition, and to 1 intervention - of which Gastric Ultrasound is the first listed.
NCT05330351 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05330351 about?
NCT05330351 is a clinical study titled "Gastric Ultrasound in Pediatric Trauma Patients". Gastric ultrasound has become increasingly utilized to examine volume and quality of gastric contents in the preoperative setting to guide anesthetic management and relay risk of aspiration in both adult and pediatric medicine. Gastric fluid volumes in trauma patients are thought to be elevated due ...
What is the current status of trial NCT05330351?
This trial is currently active not recruiting. The enrollment target is 40 participants. The study started on 2022-03-26. Estimated completion is 2026-12-31.
What conditions does trial NCT05330351 study?
This clinical trial studies the following conditions: Aspiration, Trauma; Complications.
What interventions are being tested in trial NCT05330351?
The interventions under investigation include: Gastric Ultrasound (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT05330351?
This trial is sponsored by Children's Hospital of Philadelphia, which has 431 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05330351 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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