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

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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01282099

Enrollment

Registered

2011-01-24

Start date

2011-09-30

Completion date

2013-02-28

Last updated

2014-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Intensive Care Unit

Keywords

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 15 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Comparison of data obtained using Near Infrared Spectroscopy (NIRS) versus traditional Pediatric Intensive Care Unit (PICU) clinical parameters	48 hours	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).

Countries

United States

Outcome results