N/A
Completed N=25
Accuracy of Methemoglobin Measurement for Rainbow DCI Sensors
Healthy
Source: ClinicalTrials.gov NCT03124927 ↗
Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcomePrimary: Accuracy of Sensor by Arms Calculation — 0.87 percentage
Summary
In this study, the level of methemoglobin (HbMet) will be increased in a controlled manner by administering sodium nitrite intravenously in healthy volunteers. The accuracy of a noninvasive HbMet measurement by a DCI pulse oximeter sensor will be assessed by comparison to blood measurements from a laboratory analyzer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Accuracy of Sensor by Arms Calculation |
0.87 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects must understand and consent to be in the study
- American Society of Anesthesiology Class I (Healthy subjects without any systemic disease at all).
Exclusion Criteria
- Subjects who have any systemic disease at all.
- Subjects who do not understand the study and the risks involved.
- Current smokers.
- Subjects who are pregnant.
Data sourced from ClinicalTrials.gov (NCT03124927). 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. Informational only — not medical advice.