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

History of Changes

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:

Lima A, Bakker J. Noninvasive monitoring of peripheral perfusion. Intensive Care Med. 2005 Oct;31(10):1316-26. Epub 2005 Sep 17. Review.

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

Lima AP, Beelen P, Bakker J. Use of a peripheral perfusion index derived from the pulse oximetry signal as a noninvasive indicator of perfusion. Crit Care Med. 2002 Jun;30(6):1210-3.

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

Prough DS, Pollard V. Cerebral near-infrared spectroscopy: ready for prime time? Crit Care Med. 1995 Oct;23(10):1624-6. No abstract available.

Feldman MD, Petersen AJ, Karliner LS, Tice JA. Who is responsible for evaluating the safety and effectiveness of medical devices? The role of independent technology assessment. J Gen Intern Med. 2008 Jan;23 Suppl 1:57-63. Review.

Müllner M, Sterz F, Binder M, Hirschl MM, Janata K, Laggner AN. Near infrared spectroscopy during and after cardiac arrest--preliminary results. Clin Intensive Care. 1995;6(3):107-11.

Schwarz G, Litscher G, Kleinert R, Jobstmann R. Cerebral oximetry in dead subjects. J Neurosurg Anesthesiol. 1996 Jul;8(3):189-93.

Tobias JD. Cerebral oximetry monitoring with near infrared spectroscopy detects alterations in oxygenation before pulse oximetry. J Intensive Care Med. 2008 Nov-Dec;23(6):384-8.

Tobias JD. Cerebral oximetry monitoring provides early warning of hypercyanotic spells in an infant with tetralogy of Fallot. J Intensive Care Med. 2007 Mar-Apr;22(2):118-20.

Lee TS, Hines GL, Feuerman M. Significant correlation between cerebral oximetry and carotid stump pressure during carotid endarterectomy. Ann Vasc Surg. 2008 Jan;22(1):58-62. Epub 2007 Nov 26.

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 June 17, 2013

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