Hemorrhagic ShockNCT07810907
Effect of Resuscitation on Gastric Emptying Using POCUS in Pediatric Trauma Patients
An observational study of Hemorrhagic Shock and Pediatric Trauma, run by Assiut University.
Trial summary
Pediatric trauma often leads to hemorrhagic shock, which reduces blood flow to the digestive tract and delays gastric emptying. This delay can cause fluid and food to remain in the stomach, increasing the risk of pulmonary aspiration during urgent airway management or emergency anesthesia. Read more about this study
- Who is it for?
- Ages 2 to 7 years
- Conditions the study is for
- Hemorrhagic Shock, Pediatric Trauma, Delayed Gastric Emptying
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Nov 2027
- 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 2 to 7 years
- All sexes
- Child
Study population: Pediatric trauma patients aged 2 to 7 years presenting to the Emergency Department at Assiut University Hospital with hemorrhagic shock requiring hemodynamic resuscitation. Eligible participants are hemodynamically stable enough to undergo point-of-care gastric ultrasound (POCUS) examination without delaying critical emergency interventions. Patients with known preexisting gastrointestinal motility disorders, prior upper gastrointestinal surgery, significant abdominal injury affecting motility, gastric decompression before initial imaging, isolated head trauma, or immediate surgical needs are excluded.
Who may be able to join
- Pediatric patients aged 2 to 7 years presenting with trauma.
- Presenting with hemorrhagic shock requiring hemodynamic resuscitation (diagnosed according to Advanced Paediatric Life Support [APLS] guidelines based on clinical and laboratory evidence of inadequate tissue perfusion secondary to acute blood loss, such as age-adjusted hypotension, tachycardia, prolonged capillary refill time > 2 seconds, weak peripheral pulses, altered mental status, elevated serum lactate, and/or increased base deficit).
- Hemodynamically stable enough to undergo point-of-care gastric ultrasound (POCUS) examination without delaying emergency medical management.
Who cannot join
- Known gastrointestinal diseases affecting gastric motility (e.g., gastric outlet obstruction, intestinal obstruction).
- History of prior upper gastrointestinal surgery.
- Significant abdominal injury that may affect gastric motility.
- Need for immediate emergency surgical intervention before completion of study baseline assessments.
- Inability to adequately perform gastric POCUS (e.g., extensive abdominal wounds, surgical emphysema, or poor acoustic window).
- Gastric decompression performed before the initial ultrasound assessment.
- Isolated head injury.
About this study
Official title: Effect of Resuscitation on Gastric Emptying by Gastric Residual Volume Assessment Using Point of Care Ultrasonography in Pediatric Trauma Patients
Pediatric trauma often leads to hemorrhagic shock, which reduces blood flow to the digestive tract and delays gastric emptying. This delay can cause fluid and food to remain in the stomach, increasing the risk of pulmonary aspiration during urgent airway management or emergency anesthesia. Point-of-care ultrasound (POCUS) is a bedside, non-invasive tool that allows clinicians to evaluate stomach contents and estimate gastric volume in real time.
The primary purpose of this study is to evaluate whether restoring systemic blood flow through hemodynamic resuscitation improves gastric emptying and decreases gastric residual volume in injured children.
Participants aged 2 to 7 years presenting to the emergency department with trauma and hemorrhagic shock will receive standard resuscitation according to pediatric advanced life support guidelines. Bedside gastric ultrasound will be performed to measure the antral cross-sectional area and calculate gastric residual volume before resuscitation begins, immediately following initial resuscitation, and every 6 hours for up to 48 hours. Ultrasound procedures are observational and will not delay any standard trauma care or urgent surgical interventions.
- Keywords
- Point-of-Care Ultrasound (POCUS), Gastric Residual Volume, Gastric Antral Cross-Sectional Area, Hemodynamic Resuscitation, Pulmonary Aspiration Risk, Pediatric Emergency Medicine
- Medical subject headings
- Shock, Hemorrhagic, Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric Trauma Resuscitation Cohort | Pediatric trauma patients aged 2 to 7 years presenting to the Emergency Department with hemorrhagic shock requiring hemodynamic resuscitation. Participants undergo point-of-care gastric ultrasonography (POCUS) to assess gastric residual volume (GRV) and antral cross-sectional area (CSA) before resuscitation, immediately following successful hemodynamic resuscitation, and subsequently every 6 hours for up to 48 hours. Resuscitation protocols, clinical parameters, and standard trauma care are administered according to institutional and Advanced Pediatric Life Support (APLS) guidelines without delay. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gastric Residual Volume (GRV)
Change in gastric residual volume (mL/kg) from pre-resuscitation baseline to immediately after completion of hemodynamic resuscitation. Antral cross-sectional area (CSA) will be measured by point-of-care gastric ultrasound (POCUS) in the right lateral decubitus position (CSA = AP × CC × π/4), and gastric volume will then be estimated using the Spencer formula and normalized to body weight (mL/kg).
Measured: Baseline, Up to 4 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemorrhagic ShockStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Mohamed El Sayed Hassan, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07810907
- Sponsor's protocol ID
- Pediatric Trauma Gastric POCUS
- Status last verified
- Sep 2026
- First submitted
- 4 Sep 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Resuscitation on Gastric Emptying by Gastric Residual Volume Assessment Using Point of Care Ultrasonography in Pediatric Trauma Patients
- ClinicalTrials.gov ID
- NCT07810907
- Acronym / sponsor ID
- Pediatric Trauma Gastric POCUS
- Keywords
- Point-of-Care Ultrasound (POCUS), Gastric Residual Volume, Gastric Antral Cross-Sectional Area, Hemodynamic Resuscitation, Pulmonary Aspiration Risk, Pediatric Emergency Medicine
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 9 Sep 2026 (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.
Pediatric trauma often leads to hemorrhagic shock, which reduces blood flow to the digestive tract and delays gastric emptying. This delay can cause fluid and food to remain in the stomach, increasing the risk of pulmonary aspiration during urgent airway management or emergency anesthesia. Point-of-care ultrasound (POCUS) is a bedside, non-invasive tool that allows clinicians to evaluate stomach contents and estimate gastric volume in real time.
The primary purpose of this study is to evaluate whether restoring systemic blood flow through hemodynamic resuscitation improves gastric emptying and decreases gastric residual volume in injured children.
Participants aged 2 to 7 years presenting to the emergency department with trauma and hemorrhagic shock will receive standard resuscitation according to pediatric advanced life support guidelines. Bedside gastric ultrasound will be performed to measure the antral cross-sectional area and calculate gastric residual volume before resuscitation begins, immediately following initial resuscitation, and every 6 hours for up to 48 hours. Ultrasound procedures are observational and will not delay any standard trauma care or urgent surgical interventions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric Trauma Resuscitation Cohort | – | –Pediatric trauma patients aged 2 to 7 years presenting to the Emergency Department with hemorrhagic shock requiring hemodynamic resuscitation. Participants undergo point-of-care gastric ultrasonography (POCUS) to assess gastric residual volume (GRV) and antral cross-sectional area (CSA) before resuscitation, immediately following successful hemodynamic resuscitation, and subsequently every 6 hours for up to 48 hours. Resuscitation protocols, clinical parameters, and standard trauma care are administered according to institutional and Advanced Pediatric Life Support (APLS) guidelines without delay. |
Who may qualify
- Ages
- 2 to 7 years
- Sex
- All
- Age groups
- Child
- Study population
- Pediatric trauma patients aged 2 to 7 years presenting to the Emergency Department at Assiut University Hospital with hemorrhagic shock requiring hemodynamic resuscitation. Eligible participants are hemodynamically stable enough to undergo point-of-care gastric ultrasound (POCUS) examination without delaying critical emergency interventions. Patients with known preexisting gastrointestinal motility disorders, prior upper gastrointestinal surgery, significant abdominal injury affecting motility, gastric decompression before initial imaging, isolated head trauma, or immediate surgical needs are excluded.
Key inclusion criteria (3 listed)
- Pediatric patients aged 2 to 7 years presenting with trauma.
- Presenting with hemorrhagic shock requiring hemodynamic resuscitation (diagnosed according to Advanced Paediatric Life Support [APLS] guidelines based on clinical and laboratory evidence of inadequate tissue perfusion secondary to acute blood loss, such as age-adjusted hypotension, tachycardia, prolonged capillary refill time > 2 seconds, weak peripheral pulses, altered mental status, elevated serum lactate, and/or increased base deficit).
- Hemodynamically stable enough to undergo point-of-care gastric ultrasound (POCUS) examination without delaying emergency medical management.
Key exclusion criteria (7 listed)
- Known gastrointestinal diseases affecting gastric motility (e.g., gastric outlet obstruction, intestinal obstruction).
- History of prior upper gastrointestinal surgery.
- Significant abdominal injury that may affect gastric motility.
- Need for immediate emergency surgical intervention before completion of study baseline assessments.
- Inability to adequately perform gastric POCUS (e.g., extensive abdominal wounds, surgical emphysema, or poor acoustic window).
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
Change in Gastric Residual Volume (GRV)
Time frame: Baseline, Up to 4 Hours
Change in gastric residual volume (mL/kg) from pre-resuscitation baseline to immediately after completion of hemodynamic resuscitation. Antral cross-sectional area (CSA) will be measured by point-of-care gastric ultrasound (POCUS) in the right lateral decubitus position (CSA = AP × CC × π/4), and gastric volume will then be estimated using the Spencer formula and normalized to body weight (mL/kg).
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 9 Sep 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemorrhagic Shock and Pediatric Trauma, 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 3 inclusion and 7 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 9 Sep 2026. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Gastric Residual Volume (GRV) (time frame: Baseline, Up to 4 Hours). 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 9 Sep 2026.