- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04973592
Evaluation of Professional Practices in the Management of Blunt Abdominal Trauma in Children in the Pediatric Emergency
Evaluation of Professional Practices in the Management of Blunt Abdominal Trauma in Children in the Pediatric Emergency Department of the Nancy's University Hospital Between 2011 and 2020 : Indentify Children at Low Risk of Intra Abdominal Injuries
The aim of our study is primarily to evaluate the professional practices over the last years in the pediatric emergencies of the Nancy's Hospital for the BATiC.
This, in order to identify the traumatic mechanisms and the initial clinical elements which would make it possible to detect the patients at low risk of developing visceral lesions. Then, a management could be proposed which would rationalize the use of additional examinations and would favor the monitoring and the clinical reassessment after the initial management of a minor trauma.
The study of the data will then aim to establish a composite score (anamnestic and clinical) of initial evaluation, from which could result a uniform management protocol (clinical, biological and imaging) of the minor BATiC, of the intermediate BATiC and the major BATiC, applicable to pediatric emergencies at the Nancy's Hospital.
Study Overview
Status
Detailed Description
For children aged 1 to 18, trauma is one of the leading causes of death, ahead of cancer and congenital malformations. The traumatic mechanisms are mainly accidents on public roads (car accidents, two-wheel accidents, accidents involving a pedestrian), sports accidents (especially cycling and horse riding), falls from a high height or onto a blunt object, and intentional or unintentional direct hits. Mortality is mainly correlated with involvement of the skull, thorax and abdomen and there is a clear male predominance (sex ratio 2 to 3 boys / 1 girl).
In France, blunt abdominal trauma in children (BATiC) is a frequent reason for consultation in pediatric emergencies. It accounts for 20 to 30% of childhood trauma, among which 10 to 30% result in potentially life-threatening intra-abdominal injuries (IAI). In order of frequency, the organs most affected are the spleen, the liver, kidneys and the pancreas. Rarely, hollow organs such as the small intestine, the duodenum, the colon, or the stomach can be affected. In rarer occasion, sores of the mesentery may be seen to.
BATiC is opposed to penetrating abdominal trauma, which accounts for only 5 to 15% of abdominal trauma in children. It is frequently part of a multiple trauma defined by "a child who has suffered a trauma whose kinetics are likely to cause at least two lesions, at least one of which can be life-threatening".
While multiple trauma accounts for only 14% of childhood trauma, it is nonetheless the main cause of death after the age of 1. For several years, this has motivated the establishment of emergency treatment protocols under the impetus of the development of "trauma centers". Therefore, polytrauma has well-codified diagnostic criteria and precise and systematic management, applicable to pediatric emergencies. Regarding the isolated BATiC, the management is less unequivocal. Although it is more frequent, BATiC with low or medium kinetics does not benefit from any clear management protocol.
Indeed, the management of a child admitted for BATiC in the pediatric emergency room does not necessarily take into account the traumatic mechanism. The course of action currently adopted involves at least an initial clinical evaluation, sometimes repeated after a period of monitoring. Then it is frequently supplemented by the performance of a blood test and imaging aimed at detecting possible IAI.
In current practice, some practitioners choose this systematic approach of BATiC, including complementary examinations from the outset, in order to never ignore an IAI. Others seem to support a more reserved attitude to the use of complementary exams when the initial assessment is reassuring. It is clear that many abdominal traumas are not complicated by any visceral injury. Especially when the traumatic mechanism is minimal and when the initial clinical evaluation does not identify elements of seriousness. In these different situations, carrying out additional examinations may indeed seem excessive.
Therefore, there is a great heterogeneity of BATiC and a strongly practitioner-dependent care which does not always take into account the minor traumatic mechanism.
Establishing a validated management protocol for BATiC, as can be the case with polytrauma, is difficult due to the great diversity of traumatic mechanisms and their variable kinetics. All the more so since the same mechanism does not systematically expose people to the same lesions depending on the child's age and its morphological characteristics. It is fundamental to take into consideration the anatomical and physiological specificities of the growing child which define his fragility in the face of abdominal trauma. Another difficulty lies in the anamnestic collection of facts which may be limited due to the child's age, his apprehension (hospital environment, reaction of the caregiver), the medical context (general condition, underlying pathology, psychological state) and the social context (particular case of mistreatment). This is all the more difficult when the trauma is not seen by a third party at all.
Several studies have already sought to define predictive scores for IAI. These scores are established after performing additional laboratory tests and almost always include performing an abdominal ultrasound. They have the advantage of reducing the use of the scanner, thus exposure to ionizing rays, but do not simplify the management of minor trauma for which it would be possible not to perform additional examinations at all, if they are defined beforehand.
Retrospective study of the anamnestic and clinical elements of patients without any IAI could allow the identification of clinical situations in which the performance of complementary examinations is not necessary. In this way, the course of action for minor trauma could be simplified by promoting surveillance and clinical reassessment rather than the routine use of additional tests, thereby reducing the time spent in the pediatric emergency room.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Marine Pettini
- Email: marine.pettini@gmail.com
Study Contact Backup
- Name: Julie Lienard
- Phone Number: 0383154673
- Email: julie.lienard@orange.fr
Study Locations
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-
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Nancy, France, 54000
- Marine Pettini
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patient aged 0 to 18 years consulting the Pediatric Emergency Department of the Nancy University Hospital.
- Primary care
- Blunt abdominal trauma
Exclusion Criteria:
- Secondary management
- Polytrauma
- Open abdominal trauma / Penetrating wound
- Polyhandicap
- Pre-existing major digestive or urinary pathology (single kidney, renal or hepatic transplantation...)
- Pre-existing hemostasis or hepatic disorders or trauma (inborn or acquired causes)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Child with Blunt Abdominal Trauma
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Characteristics of the blunt abdominal trauma studied : Trauma mechanisms
Time Frame: Day 0
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fall from a bicycle, a horse, a height, road - belted or unbelted accident, two-wheeler accident, blows inflicted
|
Day 0
|
|
Characteristics of the blunt abdominal trauma studied : Trauma kinetics
Time Frame: Day 0
|
low (< 50km/h) or high (> 50km/h)
|
Day 0
|
|
Clinical evaluation : Pain
Time Frame: Day 0
|
visual analog scale : 0 to 10
|
Day 0
|
|
Clinical evaluation : Location of pain
Time Frame: Day 0
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9 abdominal quadrants
|
Day 0
|
|
Clinical evaluation : Type of pain
Time Frame: Day 0
|
pain, defense or contracture
|
Day 0
|
|
Hemodynamic evaluation : Heart rate
Time Frame: Day 0
|
beat/min
|
Day 0
|
|
Hemodynamic evaluation : Blood pressure
Time Frame: Day 0
|
mmHg
|
Day 0
|
|
Hemodynamic evaluation : Respiratory rate
Time Frame: Day 0
|
cycle/min
|
Day 0
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Demographic criteria of the study population : Age
Time Frame: Day 0
|
in months
|
Day 0
|
|
Demographic criteria of the study population : Gender
Time Frame: Day 0
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male or female
|
Day 0
|
|
Time to management : Time between trauma and consultation
Time Frame: Day 0
|
minutes Management time (medical evaluation, blood work, imaging)
|
Day 0
|
|
Time to management : Management time
Time Frame: Day 0
|
medical evaluation, blood work, imaging
|
Day 0
|
|
Biological examinations : Blood count
Time Frame: Day 0
|
g/dL
|
Day 0
|
|
Biological examinations : Liver enzyme
Time Frame: Day 0
|
UI/L
|
Day 0
|
|
Biological examinations : Pancreatic enzyme
Time Frame: Day 0
|
UI/L
|
Day 0
|
|
Biological examinations : Coagulation test
Time Frame: Day 0
|
prothrombin time
|
Day 0
|
|
Biological examinations : Blood group
Time Frame: Day 0
|
G/L
|
Day 0
|
|
Imaging examinations : Imaging
Time Frame: Day 0
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body scanner, abdominal-pelvic scanner or ultrasound
|
Day 0
|
|
Imaging examinations : Imaging findings
Time Frame: Day 0
|
presence of an effusion, hollow organ or solid organ lesion + AAST classifications
|
Day 0
|
|
Surgical advice
Time Frame: Day 0
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Surgical opinion required
|
Day 0
|
|
Orientation
Time Frame: Day 0
|
Return home or Hospitalization Hospitalization (surgery,intensive care)
|
Day 0
|
|
Type of management
Time Frame: Day 0
|
Medical or surgical management
|
Day 0
|
|
Second consultation at emergency
Time Frame: 30 days
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Consultation (within 1 month)
|
30 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Marine Pettini
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020PI292
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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