NCT02950181

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 299 (actual)
• Sponsor: Arkansas Children's Hospital Research Institute · Academic / Other
• Sex: All
• Age: 1 Day – 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stroke
• Diabetic Ketoacidosis
• Increased Intracranial Pressures
• Altered Mental Status

Interventions

Type	Name	Description
DEVICE	NIRS	Correlating the NIRS/Cerebral Oximetry readings to the various critical ill and injured pediatric patients, trends, interventions, and outcomes

Timeline

• Start date: 2014-07-29
• Primary completion: 2019-01-01
• Completion: 2019-01-01
• First posted: 2016-11-01
• Last updated: 2020-05-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study