Pulse Oximetry_Performance Testing- PCBA-1 (Printed Circuit Board Assembly) NEO/PEDS

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01797250

Enrollment

Registered

2013-02-22

Start date

2013-05-31

Completion date

2013-07-31

Last updated

2013-12-06

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

Conditions

Subjects With an Existing Intra-arterial Line

Brief summary

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

Interventions

None listed

Study design

Observational model

CASE_ONLY

Eligibility

Sex/Gender

ALL

Age

1 Months to 18 Years

Healthy volunteers

Yes

Inclusion criteria

1. Subject or legal guardian is willing and able to sign informed consent prior to study initiation. 2. 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. 3. Subject satisfies a specified sensor requirement (see Table 1). 4. Requires use of an intra-arterial line for medical reasons such as continuous blood pressure monitoring or frequent arterial blood draws. 5. Subject is able to accommodate multiple sensors. 6. Neonatal subjects up to 1 month of age or Pediatric subjects 1 month up to 18 years old.

Exclusion criteria

1. 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. 2. 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. 3. Subject has severe contact allergies that may react to standard adhesive materials found in pulse oximetry sensors. 4. Subject cannot be reliably monitored with a pulse oximeter as a result of inadequate pulsatile signals. 5. Subject has had a procedure using injected intravascular dyes within 24 hours preceding testing

Design outcomes

Primary

Measure	Time frame
SpO2 Accuracy (percentage of blood oxygen saturation)	Planned duration of study was up to 12 months. Duration of subject participation: 1-24 hours

Countries

United States

Outcome results