Clinical trial NCT04876872: Modified Pediatric Early Warning Score and Modified PRISA II During COVID-19 Pandemic
Official title: The Effectiveness of Modified Pediatric Early Warning Score and Pediatric Hospitalization Risk Scoring II in Patients Applying to the Pediatric Emergency Unit During Pandemic Period Associated With COVID-19 Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Critical Illness
Keywords: critically ill child
pediatric early warning score
mPEWS
mPRISA II
Lead sponsor: Karadeniz Technical University
Sponsor class: OTHER
First posted: 2021-05-07
Enrollment: 894
Sex: ALL
Minimum age (years): 28
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pediatric patients aged between 28 days and 18 years who applied to the Pediatric Emergency Unit

Brief summary: One of the most important factors in pediatric emergency units is the correct decision of the patient inpatient or outpatient treatment.

If the disease progresses critically, the decision of hospitalization comes to the fore. However, in this case, it is very important to make the right decision and to determine the situation in a short time.

Children give different physiological responses to diseases according to age group. For this reason, some scoring, which require objective parameters, have been developed in order to predict the critical processes of the patients and to intervene at the right time.

While such scoring is frequently used in adult emergency units, it is understood that studies on this issue are not sufficient in pediatric emergency units.

The purpose of our study; To evaluate the population of children admitted to the pediatric emergency unit with the modified Pediatric Early Warning Scoring (mPEUS) and Pediatric Hospitalization Risk Scoring II (PRISA II), to predict hospitalization and discharge from the emergency service, and to demonstrate the effectiveness of the scoring to identify critically ill children in the correct early period.

Detailed description: Triage is the primary step where the first treatment service of a patient admitted to the emergency unit is initiated.

The purpose of triage in the emergency room is a rapid assessment to determine the order of priority. Emergency service triage systems have been developed mainly to identify the "most urgent" or potentially "critical pediatric" cases and give priority to treatment for these patients.

If the patient's condition is critical in the pediatric emergency unit, the decision for outpatient treatment / hospitalization should be made quickly but in the most correct way. Regardless of the diagnosis, the main problem is; early diagnosis of the critical patient, directing the patient to the appropriate area in the emergency department for acute stabilization, and more importantly, to decide quickly whether the patient will be hospitalized in order to continue the treatment and accelerate the flow of the emergency service. It is known that children who unexpectedly worsen in the hospital environment will have observable features in the period before the seriousness of their condition is understood. It has been emphasized in the studies conducted that ways to understand early whether there is a problem in a child should be investigated. For this reason, some scores that require objective parameters have been developed in order to predict the critical processes of the patients and to intervene at the right time. These scores should be viewed not only as a score, but as a complementary systematic approach used to improve pediatric patient safety and clinical outcomes. mPEUS; These are physiology-based scoring systems developed to identify patients with clinical worsening. Studies have reported that with these scores, the treatment of critical emergency patients can be started without delay. mPEUS has been developed to provide a reproducible assessment of the pediatric patient's condition based on physiological parameters. In addition, the use of these scores in the emergency service and inpatient services ensures continuity in patient evaluation. To date, there are very few data regarding the use of mPEUS in children presenting to the emergency department. Although many mPEUS have been developed and tested, uncertainty remains as to which system or system feature is most beneficial for pediatric patients. Therefore, studies on this subject should be increased. mPEUS is an essential tool for patient safety. The use of mPEUS during the initial evaluation can help prevent poor neurological results, deterioration of the patient's condition, and reduce mortality with rapid intervention. In limited studies conducted in pediatric emergency units, it has been shown that these early warning scores can determine the children who need to be admitted to the Pediatric Intensive Care Unit (PICU). With this scoring, the early hospitalization of the patient in the emergency room can be accurately predicted. Such early warning scoring can be used to shorten patients' hospitalization and waiting times in emergency rooms. The PRISA II system, similar to mPEUS but used only to predict inpatients, has also been developed. This scale includes initial history, physiological parameters, chronic disease status, treatments applied in the emergency department and laboratory values. It is appropriate to use PRISA II to control the severity of the disease. There is not enough data in the literature regarding the efficacy of both mPEUS and PRISA II scoring in the epidemic period associated with COVID-19. With this study, it is aimed to provide efficiency by using these scoring in patients who applied to the pediatric emergency unit during the pandemic period.

Eligibility criteria: Inclusion Criteria:

- Pediatric patients aged between 28 days and 18 years, who applied to the Pediatric Emergency Unit

Exclusion Criteria:

* In the follow-up or at the begining, patients who are presenting with cardiorespiratory arrest
* Intubated patients,
* Trauma patients
* Neonatal period (\<28 days),
* Patients who leave the hospital at the request of their family before the end of the diagnosis or treatment process
* Patients who do not have permission from their parents at the beginning

Primary outcomes:
measure: modified pediatric early warning score
timeFrame: 1 February - 31 July 2021,
measure: mPRISA II
timeFrame: 1 February - 31 July 2021
measure: Changes in modified pediatric early warning score over time
timeFrame: 1 February - 31 July 2021
Secondary outcomes:
measure: Length of stay in pediatric emergency
timeFrame: 1 February - 31 July 2021
measure: number of children who returned to the emergency service
timeFrame: 1 February - 31 July 2021
measure: which service is admitted to
timeFrame: 1 February - 31 July 2021
measure: number of children with severe acute respiratory syndrome coronavirus 2
timeFrame: 1 February - 31 July 2021
measure: children who contacted the person with COVID-19
timeFrame: 1 February - 31 July 2021
measure: history of COVID-19 in the past
timeFrame: 1 February - 31 July 2021
Other outcomes:
Locations:
city: Trabzon
country: Turkey
facility: Karadeniz Technical University Faculty of Medicine Farabi Hospital
Study officials:
affiliation: Karadeniz Technical University Faculty of Medicine
name: Ahmet K Özkaya, MD, phD
role: STUDY_DIRECTOR
affiliation: Karadeniz Technical University Faculty of Medicine
name: Bihter Şen Şahin, MD
role: PRINCIPAL_INVESTIGATOR
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