Descriptive Analysis of Near Infrared Spectroscopy in Critically Ill and Injured Pediatric and Neonatal Patients

Not Applicable

Terminated

• Conditions: Altered Mental Status; Diabetic Ketoacidosis; Stroke; Increased Intracranial Pressures
• Interventions: Device: NIRS

• Registration Number: NCT02950181
• Lead Sponsor: Arkansas Children's Hospital Research Institute

Brief Summary

This study involves looking at Cerebral oximetry measurements in pediatric and neonatal patients who are experiencing a critical illness. Such as Altered mental status, seizures, trauma, sepsis, etc.

Detailed Description

At Arkansas Children's Hospital (ACH) Pediatric Emergency Department (PED), NIRS cerebral tissue oxygenation rSO2 monitoring has become an adjunct noninvasive monitoring assessment tool along with Pulse Oximetry and End-Tidal CO2 in the critically ill and injured neonatal and pediatric patients' resuscitation endeavors or management. This has become a standard monitoring tool for patients who require medical (possible strokes, diabetic ketoacidosis, increased intracranial pressure, altered mental status, sepsis, drowning, shock, rapid sequence intubations, seizures, altered mental status, strokes, possible shunt malfunctions) or trauma (non-accidental trauma, Level One or Two Trauma with altered mental status, traumatic brain injury, altered mental status with trauma history, vascular compromise) resuscitation efforts.

Data will be collected as a retrospective and prospective chart review from the electronic medical record of patients that were treated in the pediatric emergency department of Arkansas Children's Hospital from 10-1-13 who require medical (possible strokes, diabetic ketoacidosis, increased intracranial pressure, altered mental status, sepsis, drowning, shock, rapid sequence intubations, seizures, altered mental status, strokes, possible shunt malfunctions) or trauma (non-accidental trauma, Level One or Two Trauma with altered mental status, traumatic brain injury, altered mental status with trauma history, vascular compromise) resuscitation efforts. This study will be based on the patient information recorded in these records, such as age, medications delivered, vital signs, interventions and outcomes and compared to their PED NIRS cerebral tissue oxygenation rSO2 data. All study subject materials will be assigned a unique identifying code or number. The cerebral NIRS rSO2 data will be collected/graphed and de-identified.

Study Timeline

• Study Start: 2014-07-29
• Study First Submitted: 2016-10-19
• Study First Submitted QC: 2016-10-27
• Study First Posted: 2016-11-01
• Primary Completion: 2019-01-01
• Study Completion: 2019-01-01
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-26
• Last Update Posted: 2020-05-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 299

Inclusion Criteria

• Trauma: non-accidental trauma, Level One or Two Trauma with altered mental status, traumatic brain injury, altered mental status with trauma history, vascular compromise
• Or medical: possible strokes, diabetic ketoacidosis, increased intracranial pressure, altered mental status, sepsis, drowning, shock, rapid sequence intubations, seizures, altered mental status, strokes, possible shunt malfunctions

Exclusion Criteria

• none

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Specific Aim	NIRS	Correlating the NIRS/Cerebral Oximetry readings to the various critical ill and injured pediatric patients, trends, interventions, and outcomes

Primary Outcome Measures

Name	Time	Method
Observing Cerebral oximetry readings when patients present to the pediatric emergency department	4 years	All study data will be obtained from the physical or electronic medical records obtained at Arkansas Children's Hospital. Patient's NIRS and vital signs data will be in an excel format with de-identified patient information which will be age, interventions, and etiology as denoted as Medical vs. Trauma (see study population for inclusion criteria). This is a data review with de-identified patient chart analysis for age, weight, past medical histories, co-morbidities, medical or surgical interventions, medications, seizures, duration of events, cardiac arrest, respiratory failure, intubations, and outcomes. All relevant information will be entered into a Redcap database. All study subject materials will be assigned a unique identifying code or number.

Trial Locations

Locations (1)

Arkansas Children's Hospital; 🇺🇸 Little Rock, Arkansas, United States