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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01282099
Recruitment Status : Completed
First Posted : January 24, 2011
Last Update Posted : June 26, 2014
Information provided by (Responsible Party):
Akron Children's Hospital

Brief Summary:
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.

Condition or disease
Pediatric Intensive Care Unit

Study Type : Observational
Actual Enrollment : 22 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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)
Study Start Date : September 2011
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

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

Primary Outcome Measures :
  1. 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).

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Ages Eligible for Study:   up to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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

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 identifier (NCT number): NCT01282099

United States, Ohio
Akron Children's Hospital
Akron, Ohio, United States, 44308
Sponsors and Collaborators
Akron Children's Hospital
Principal Investigator: Michael L Forbes, MD, FAAP Akron Children's Hospital

Webster JG 1997 Design of Pulse Oximeters (Bristol: Institute of Physics Publishing)
Armonda RA, McGee B, Veznadaraglu E, Rosenwasser RH. Near-infrared spectroscopy (NIRS) measurements of cerebral oximetry in the neurovascular ICU. Crit Care Med 1999; 27:173
Kohn, Linda T, Corrigan, J, Donaldson, Molla S. To err is human: building a safer health system. Institute of Medicine (U.S.). Committee on Quality of Health Care in America. Vol. 627, Nov.1999
Society of Critical Care Medicine Consensus Conference on Physiologic Moitoring Devices: Standards of Evidence for the Safety and Effectiveness of Critical Care Monitoring Devices and Related Interventions, Deptember 13-14, 1994.

Responsible Party: Akron Children's Hospital Identifier: NCT01282099     History of Changes
Other Study ID Numbers: 100603
First Posted: January 24, 2011    Key Record Dates
Last Update Posted: June 26, 2014
Last Verified: June 2014

Keywords provided by Akron Children's Hospital:
all children entering the PICU eligible for enrollment
age range: neonate to 16 years