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

Pediatric Intensive Care Unit Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01282099
• Other study ID #: 100603
• Status: Completed
• Phase: N/A
• First received: January 21, 2011
• Last updated: June 24, 2014
• Start date: September 2011
• Est. completion date: February 2013

Study information

• Verified date: June 2014
• Source: Akron Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 15 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pediatric Intensive Care Unit

Locations

Country	Name	City	State
United States	Akron Children's Hospital	Akron	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Akron Children's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (14)

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

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. doi: 10.1007/s11606-007-0275-4. Review. — View Citation

Kelleher JF. Pulse oximetry. J Clin Monit. 1989 Jan;5(1):37-62. Review. — View Citation

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

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. — View Citation

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

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. — View Citation

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. — View Citation

Prough DS, Pollard V. Cerebral near-infrared spectroscopy: ready for prime time? Crit Care Med. 1995 Oct;23(10):1624-6. — View Citation

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

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.

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. — View Citation

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. — View Citation

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

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No