Neonatal and Pediatric Studies Using a Bedside Respiratory Patient Monitoring System With the Functional Patient Monitoring PCBA-1

Medtronic - MITG2 sites in 1 country12 target enrollmentMay 2013

Overview

To determine accuracy specifications of the pulse oximeter in the NEO/PEDS subject population

Registry

clinicaltrials.gov

Start Date

May 2013

End Date

July 2013

Last Updated

12 years ago

Study Type

Observational

Sex

All

Sponsor

Responsible Party

Sponsor

•Subject or legal guardian is willing and able to sign informed consent prior to study initiation.
•Subject is able to participate for the duration of the evaluation. In most instances, the length of the study will not exceed twenty-four hours.
•Subject satisfies a specified sensor requirement (see Table 1).
•Requires use of an intra-arterial line for medical reasons such as continuous blood pressure monitoring or frequent arterial blood draws.
•Subject is able to accommodate multiple sensors.
•Neonatal subjects up to 1 month of age or Pediatric subjects 1 month up to 18 years old.

•Subjects that have an existing health condition, in which the investigators determine that safe or accurate oximetry measures may not be obtained at the areas where the pulse oximetry sensor could be placed, will not be included in the study. For example, anyone with burns, abrasions or surface lesions on the contact areas would be excluded.
•Any subject whose treatment or condition would be compromised if they were to participate in this study and any patient whose use of a pulse oximeter and sensor would present a potential for serious risk to health, safety, or welfare.
•Subject has severe contact allergies that may react to standard adhesive materials found in pulse oximetry sensors.
•Subject cannot be reliably monitored with a pulse oximeter as a result of inadequate pulsatile signals.
•Subject has had a procedure using injected intravascular dyes within 24 hours preceding testing