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OpenTrials
Completed

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

Completed

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Key information

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

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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

  1. 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.