Pediatric Trauma PatientsNCT06747403
Accuracy of Gastric POCUS in Pediatric Trauma
An observational study of Pediatric Trauma Patients, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Pediatric Trauma Patients
- How many people
- 101 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to 1 Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pediatric Trauma Patients
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour from performing gastric POCUS till performing operative procedures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start1 Mar 2025 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Trauma PatientsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 101 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hala Saad Abdel-Ghaffar, Assiut University
- Investigators
- Hala S Abdel-Ghaffar, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06747403
- Sponsor's protocol ID
- Gastric Pocus
- Status last verified
- Jan 2025
- First submitted
- 18 Dec 2024
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Sensitivity, Specificity and Predictive Accuracy of Gastric Point of Care Ultrasound in Pediatric Trauma Patients
- ClinicalTrials.gov ID
- NCT06747403
- Acronym / sponsor ID
- Gastric Pocus
- Conditions
- Pediatric Trauma Patients
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 101 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 24 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hala S Abdel-Ghaffar principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Trauma Patients, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hala S Abdel-ghaffar (+201003812011, hala_abdelghaffar@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of gastric POCUS (time frame: 1 hour from performing gastric POCUS till performing operative procedures). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2025.