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

NCT01282099 | Completed

• 1 other identifier: 100603
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Intensive Care Unit

Keywords

all children entering the PICU eligible for enrollment; age range: neonate to 16 years

Outcome Measures

Primary Outcomes (1)

• Comparison of data obtained using Near Infrared Spectroscopy (NIRS) versus traditional Pediatric Intensive Care Unit (PICU) clinical parameters

  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

Study Arms (2)

Cardiac patients

Postoperative congenital heart disease patients requiring stay in the PICU

non-cardiac patients

non-cardiac patients requiring stay in the PICU

Eligibility Criteria

• Age: Up to 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Akron Children's Hospital: lead

Study Sites (1)

Akron Children's Hospital

Akron, Ohio, 44308, United States

Location

Related Publications (14)

• Lima A, Bakker J. Noninvasive monitoring of peripheral perfusion. Intensive Care Med. 2005 Oct;31(10):1316-26. doi: 10.1007/s00134-005-2790-2. Epub 2005 Sep 17.

  PMID: 16170543 BACKGROUND

• Kelleher JF. Pulse oximetry. J Clin Monit. 1989 Jan;5(1):37-62. doi: 10.1007/BF01618369.

  PMID: 2647912 BACKGROUND

• Webster JG 1997 Design of Pulse Oximeters (Bristol: Institute of Physics Publishing)

  BACKGROUND

• 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. doi: 10.1097/00003246-200206000-00006.

  PMID: 12072670 BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• Standards of evidence for the safety and effectiveness of critical care monitoring devices and related interventions. Coalition for Critical Care Excellence: Consensus Conference on Physiologic Monitoring Devices. Crit Care Med. 1995 Oct;23(10):1756-63. doi: 10.1097/00003246-199510000-00022.

  PMID: 7587243 BACKGROUND

• Prough DS, Pollard V. Cerebral near-infrared spectroscopy: ready for prime time? Crit Care Med. 1995 Oct;23(10):1624-6. doi: 10.1097/00003246-199510000-00004. No abstract available.

  PMID: 7587225 BACKGROUND

• 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(Suppl 1):57-63. doi: 10.1007/s11606-007-0275-4.

  PMID: 18095046 BACKGROUND

• Mullner 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.

  PMID: 10150558 BACKGROUND

• Schwarz G, Litscher G, Kleinert R, Jobstmann R. Cerebral oximetry in dead subjects. J Neurosurg Anesthesiol. 1996 Jul;8(3):189-93. doi: 10.1097/00008506-199607000-00001.

  PMID: 8803829 BACKGROUND

• 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. doi: 10.1177/0885066608324380.

  PMID: 18794168 BACKGROUND

• 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. doi: 10.1177/0885066606297966.

  PMID: 17456731 BACKGROUND

• 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. doi: 10.1016/j.avsg.2007.07.022. Epub 2007 Nov 26.

  PMID: 18023554 BACKGROUND

Study Officials

• Michael L Forbes, MD, FAAP

  Akron Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2011
• First Posted: January 24, 2011
• Study Start: September 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: June 26, 2014

Record last verified: 2014-06

Locations

US (1)