N/A
N=63
SpO2 System Accuracy Testing With Different Sensors
Pulse Oximetry
Bottom Line
View on ClinicalTrials.gov: NCT01613222 ↗Enrolled (actual)
63
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcome: Primary: Accuracy Root Mean Square (ARMS) — 1.488; 1.465; 1.651; 1.352 Accuracy Root Mean Square
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Pulse oximetry (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- GE Healthcare
- Primary completion
- Feb 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Accuracy Root Mean Square (ARMS) |
1.488; 1.465; 1.651; 1.352; 2.179; 1.813 | — |
Summary
A study to test the accuracy of SpO2 sensors with various patient monitors, co-oximeters, and modules.
Eligibility Criteria
Inclusion Criteria
- Ability to provide written informed consent or have a legally authorized representative provide written informed consent
- Subjects who are 18-55 years of age
- Subjects must be willing and able to comply with study procedures
- HbCO 39.5),
- Subjects with injuries, deformities or abnormalities that may prevent proper application of the device under test,
- Smokers with COHb levels >3% or subjects who have smoked within two (2) days. Subjects will be screened for COHb levels of >3% with a Masimo Radical 7 (Rainbow).
- Subjects with known respiratory conditions (uncontrolled asthma, head cold, flu, pneumonia / bronchitis, respiratory distress / respiratory or lung surgery, emphysema, COPD, lung disease),
- Subjects with known heart or cardiovascular conditions,
- Female subjects that are actively trying to get pregnant or are pregnant,
- Subjects taking blood thinners or medications with aspirin or other antiplatelet medication in them (applies only to arterial draw study),
- Subjects with Systolic blood pressure >140mmHg,
- Subjects with Diastolic blood pressure >100mmHg,
- Subjects with heart rhythms other than a normal sinus rhythm or with respiratory sinus arrhythmia
Data sourced from ClinicalTrials.gov (NCT01613222). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.