N/A
N=11
Accuracy of Pulse Oximeters With Profound Hypoxia At Rest (NIHO16)
Hypoxia
Bottom Line
View on ClinicalTrials.gov: NCT05745675 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Accuracy of Sensor Oxygen Saturation by Arms Calculation — 2.0 percentage of SpO2
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Pulse oximeter (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Nihon Kohden
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Accuracy of Sensor Oxygen Saturation by Arms Calculation |
2.0 | — |
| SECONDARY Accuracy of Sensor Pulse Rate by Arms Calculation |
2.0 | — |
Summary
The aim of this study is to determine the accuracy of devices called pulse oximeters, which measure blood oxygen by shining light through fingers, ears or other skin, without requiring blood sampling. Study will be used with patients at rest.
Eligibility Criteria
Inclusion Criteria
- Both male and female subjects who can give written informed consent
- Healthy subjects capable of undergoing controlled hypoxemia to the levels outlined in the desaturation profile
- Meeting the demographic requirements
Exclusion Criteria
- Age below 18 or over 50
- Pregnant women
- Significant arrhythmia
- Blood pressure above 150 systolic or 90 diastolic
- Carboxyhemoglobin levels over 3%
- Subjects whom the investigator consider ineligible for the study
Data sourced from ClinicalTrials.gov (NCT05745675). 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.