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

This study is currently recruiting participants.
Verified December 2012 by Akron Children's Hospital
Sponsor:
Information provided by (Responsible Party):
Michael Forbes, Akron Children's Hospital
ClinicalTrials.gov Identifier:
NCT01282099
First received: January 21, 2011
Last updated: December 19, 2012
Last verified: December 2012
  Purpose

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
Pediatric Intensive Care Unit

Study Type: Observational
Study Design: 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)

Further study details as provided by Akron Children's Hospital:

Primary Outcome Measures:
  • Comparison of data obtained using Near Infrared Spectroscopy (NIRS) versus traditional Pediatric Intensive Care Unit (PICU) clinical parameters [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 50
Study Start Date: September 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cardiac patients
Postoperative congenital heart disease patients requiring stay in the PICU
non-cardiac patients
non-cardiac patients requiring stay in the PICU

  Eligibility

Ages Eligible for Study:   up to 15 Years
Genders Eligible for Study:   Both
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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01282099

Contacts
Contact: Michael L Forbes, MD, FAAP 330-543-4492 MForbes@chmca.org

Locations
United States, Ohio
Akron Children's Hospital Recruiting
Akron, Ohio, United States, 44308
Contact: Michael L. Forbes, MD, FAAP    330-543-4492    MForbes@CHMCA.org   
Contact: Maryan E Mathis, MS    330-543-8272    mmathis@chmca.org   
Principal Investigator: Michael L Forbes, MD, FAAP         
Sponsors and Collaborators
Akron Children's Hospital
Investigators
Principal Investigator: Michael L Forbes, MD, FAAP Akron Children's Hospital
  More Information

Publications:
Kelleher JF Pulse Oximetry. J Clin Monit 5:37-62
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

Responsible Party: Michael Forbes, MD, Akron Children's Hospital
ClinicalTrials.gov Identifier: NCT01282099     History of Changes
Other Study ID Numbers: 100603
Study First Received: January 21, 2011
Last Updated: December 19, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 17, 2014