N/A
N=12
SpO2 Accuracy of Noninvasive Pulse Oximeter Sensor
Healthy · Hypoxia
Bottom Line
View on ClinicalTrials.gov: NCT05141500 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Dec 2022
Primary outcome: Primary: Accuracy of Sensor by Arms Calculation — 1.62; 1.56; 1.48; 1.72 Root Mean Square Error (%)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- STRYKER SUSTAINABILITY SOLUTIONS PULSE OXIMETERS (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stryker Sustainability Solutions
- Primary completion
- Nov 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Accuracy of Sensor by Arms Calculation |
1.62; 1.56; 1.48; 1.72 | — |
Summary
The purpose of this clinical study is to validate the SpO2 accuracy of the Stryker Sustainability Solutions pulse oximetry sensors during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry. The end goal is to provide supporting documentation for the SpO2 accuracy validation of the reprocessed sensors.
Eligibility Criteria
Inclusion Criteria
- Good general health with no evidence of pre-existing medical problems
- Fluent in both written and spoken English
- Must be able to review informed consent and is willing to comply with study procedures
Exclusion Criteria
- Obesity (BMI >30)
- Known history of heart disease, lung disease, kidney or liver disease
- Prior diagnosis of asthma, sleep apnea, or use of CPAP
- Diabetes
- Clotting disorder
- Hemoglobinopathy or history of anemia that in the opinion of the investigators would make them unsuitable for study participation
- Any serious systemic illness
- Current smoker
- Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigator would interfere with the sensors working correctly
- History of fainting or vasovagal response
- History of sensitivity to local anesthesia
- Prior diagnosis of Raynaud's disease
- Unacceptable collateral circulation based on exam by investigators (Allen's test)
- Pregnant, lactating, or trying to get pregnant
- Unable or unwilling to provide informed consent, or unable or unwilling to comply with study procedures
- Any other condition which in the opinion of the investigators would make them unsuitable for the study
Data sourced from ClinicalTrials.gov (NCT05141500). 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.