Pulse Oximetry_Performance Testing- PCBA-1 (Printed Circuit Board Assembly) NEO/PEDS
Completed
- Conditions
- Subjects With an Existing Intra-arterial Line
- Registration Number
- NCT01797250
- Lead Sponsor
- Medtronic - MITG
- Brief Summary
To determine accuracy specifications of the pulse oximeter in the NEO/PEDS subject population
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method SpO2 Accuracy (percentage of blood oxygen saturation) Planned duration of study was up to 12 months. Duration of subject participation: 1-24 hours
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie pulse oximetry accuracy in neonatal and pediatric subjects with intra-arterial lines?
How does the PCBA-1 pulse oximeter compare to standard-of-care devices in measuring oxygen saturation in critically ill children?
Are there specific biomarkers that correlate with pulse oximetry performance variability in neonatal populations?
What adverse events are associated with continuous bedside respiratory monitoring in pediatric intensive care units?
What alternative or complementary technologies to PCBA-1 pulse oximetry are being developed for neonatal and pediatric patient monitoring?
Trial Locations
- Locations (2)
Children's Hospital- Los Angeles
🇺🇸Los Angeles, California, United States
Wasatch Neonatal
🇺🇸Orem, Utah, United States
Children's Hospital- Los Angeles🇺🇸Los Angeles, California, United States