NCT07810907

Brief 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. 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
13mo left

Started Oct 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Oct 2026Nov 2027

First Submitted

Initial submission to the registry

September 4, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 9, 2026

Completed
22 days until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

September 9, 2026

Status Verified

September 1, 2026

Enrollment Period

1 year

First QC Date

September 4, 2026

Last Update Submit

September 4, 2026

Conditions

Keywords

Point-of-Care Ultrasound (POCUS)Gastric Residual VolumeGastric Antral Cross-Sectional AreaHemodynamic ResuscitationPulmonary Aspiration RiskPediatric Emergency Medicine

Outcome Measures

Primary Outcomes (1)

  • 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).

    Baseline, Up to 4 Hours

Study Arms (1)

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.

Eligibility Criteria

Age2 Years - 7 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Shock, HemorrhagicGastroparesis

Condition Hierarchy (Ancestors)

HemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsShockStomach DiseasesGastrointestinal DiseasesDigestive System DiseasesParalysisNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident at Emergency Department

Study Record Dates

First Submitted

September 4, 2026

First Posted

September 9, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

September 9, 2026

Record last verified: 2026-09