NCT Number: NCT01797250
Pulse Oximetry_Performance Testing- PCBA-1 (Printed Circuit Board Assembly) NEO/PEDS
To determine accuracy specifications of the pulse oximeter in the NEO/PEDS subject population
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Age range
1 month–18 year
Sex eligibility
All sexes
Study type
Observational
Primary location
Children's Hospital- Los Angeles, Los Angeles, California, United States
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
SpO2 Accuracy (percentage of blood oxygen saturation)
Time frame: Planned duration of study was up to 12 months. Duration of subject participation: 1-24 hours
Sponsors and collaborators
Lead sponsor
Medtronic - MITG
Industry
Registry information
Official study title
Neonatal and Pediatric Studies Using a Bedside Respiratory Patient Monitoring System With the Functional Patient Monitoring PCBA-1
Important dates
- Study start
- 2013
- Primary completion
- 2013
- Study completion
- 2013
- First posted
- Feb 22, 2013
- Registry last updated
- Dec 6, 2013
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.