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

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ClinicalTrials.gov Identifier: NCT02950181
Recruitment Status : Recruiting
First Posted : November 1, 2016
Last Update Posted : June 29, 2018
Sponsor:
Information provided by (Responsible Party):
Thomas Abramo, 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.

Condition or disease Intervention/treatment Phase
Stroke Diabetic Ketoacidosis Increased Intracranial Pressures Altered Mental Status Device: NIRS Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Descriptive Analysis of Near Infrared Spectroscopy in Critically Ill and Injured Pediatric and Neonatal Patients
Actual Study Start Date : July 29, 2014
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2023

Arm Intervention/treatment
Experimental: Specific Aim
Correlating the NIRS/Cerebral Oximetry readings to the various critical ill and injured pediatric patients, trends, interventions, and outcomes
Device: NIRS
Correlating the NIRS/Cerebral Oximetry readings to the various critical ill and injured pediatric patients, trends, interventions, and outcomes




Primary Outcome Measures :
  1. Observing Cerebral oximetry readings when patients present to the pediatric emergency department [ Time Frame: 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.



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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02950181


Contacts
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Contact: Thomas Abramo, MD 501-364-1050 TAbramo@uams.edu
Contact: Lee Crawley, MS 501-364-3481 Crawleylj@archildrens.org

Locations
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United States, Arkansas
Arkansas Children's Hospital Recruiting
Little Rock, Arkansas, United States, 72202
Contact: Lee J Crawley, MS    501-364-3481    LCrawley@uams.edu   
Principal Investigator: Thomas J Abramo, MD         
Sub-Investigator: Matt Jaeger, MD         
Sub-Investigator: Elizabeth Storm, MD         
Sponsors and Collaborators
Arkansas Children's Hospital Research Institute

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Responsible Party: Thomas Abramo, MD, Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier: NCT02950181     History of Changes
Other Study ID Numbers: 202674
First Posted: November 1, 2016    Key Record Dates
Last Update Posted: June 29, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Additional relevant MeSH terms:
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Critical Illness
Ketosis
Diabetic Ketoacidosis
Intracranial Hypertension
Disease Attributes
Pathologic Processes
Acidosis
Acid-Base Imbalance
Metabolic Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Diabetes Complications
Endocrine System Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases