Clinical trial NCT01282099: A Critical Appraisal of the Role of Near Infrared Spectroscopy (NIRS) in the Pediatric Intensive Care Unit (PICU)
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric Intensive Care Unit
Keywords: all children entering the PICU eligible for enrollment
age range: neonate to 16 years
Lead sponsor: Akron Children's Hospital
Sponsor class: OTHER
First posted: 2011-01-24
Enrollment: 22
Sex: ALL
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility 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

Primary outcomes:
measure: Comparison of data obtained using Near Infrared Spectroscopy (NIRS) versus traditional Pediatric Intensive Care Unit (PICU) clinical parameters
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Akron
country: United States
facility: Akron Children's Hospital
state: Ohio
Study officials:
affiliation: Akron Children's Hospital
name: Michael L Forbes, MD, FAAP
role: PRINCIPAL_INVESTIGATOR
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