A Critical Appraisal of the Role of Near Infrared Spectroscopy (NIRS) in the Pediatric Intensive Care Unit (PICU)

June 24, 2014 updated by: Akron Children's Hospital

Is There a Canary in the PICU? A Critical Appraisal of the Role of Near Infrared Spectroscopy (NIRS) in the Pediatric Intensive Care Unit (PICU)

While near infrared spectroscopy is an exciting technology, scientific rigor is required in order to optimize its appropriate use in the clinical arena. This study will explore the feasibility and clinical applicability of data obtained from the NIRS device. The ability to noninvasively monitor peripheral perfusion remains an area of intense research. The most widely used method is pulse oximetry. The international mandate of its use in operating rooms in the early 1990s after the publication of the Harvard minimum standards for monitoring speaks to its unquestionable utility. Its pervasive application notwithstanding, pulse oximetry merely provides a calibrated ratio of arterial and venous hemoglobin saturation. While this data is valuable, time-tested, and even may hold the promise of accurately noninvasively trending cardiac output, cellular dysmetabolism -- hallmarks of vulnerable, yet viable tissue beds -- are beyond the predictive values of currently available devices.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

22

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Akron, Ohio, United States, 44308
        • Akron Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 15 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

neonates to 16 years of age requiring stay in the PICU postoperative congenital heart disease patients non-cardiac patients

Description

Inclusion Criteria:

  • neonates to 16 year olds
  • requiring stay in the PICU greater than 24 hours

Exclusion Criteria:

  • anticipated PICU stay less than 24 hours
  • children with ALLOW NATURAL DEATH orders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cardiac patients
Postoperative congenital heart disease patients requiring stay in the PICU
non-cardiac patients
non-cardiac patients requiring stay in the PICU

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of data obtained using Near Infrared Spectroscopy (NIRS) versus traditional Pediatric Intensive Care Unit (PICU) clinical parameters
Time Frame: 48 hours
Upon arrival to PICU, 1 lead will be place on the forehead to monitor cerebral regional saturation (CrSO2)and 1 lead will be placed on the flank to measure somatic regional saturation (SrSO2).
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Akron Children's Hospital

Investigators

  • Principal Investigator: Michael L Forbes, MD, FAAP, Akron Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (ACTUAL)

February 1, 2013

Study Completion (ACTUAL)

February 1, 2013

Study Registration Dates

First Submitted

January 21, 2011

First Submitted That Met QC Criteria

January 21, 2011

First Posted (ESTIMATE)

January 24, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

June 26, 2014

Last Update Submitted That Met QC Criteria

June 24, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 100603

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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