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N/A Completed N=51 Other

Accuracy of Methemoglobin Measurement for Rainbow Universal Pulse Oximeter Sensor

Healthy
Source: ClinicalTrials.gov NCT03125005 ↗
Enrolled (actual)
51
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcomePrimary: Accuracy of Sensor by Arms Calculation — 0.63 Percentage of total hemoglobin

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 sensor will be assessed by comparison to blood measurements from a laboratory analyzer.

Outcome Measures

OutcomeResultp-value
PRIMARY
Accuracy of Sensor by Arms Calculation
0.63

Eligibility Criteria

Inclusion Criteria

  • The subject is male or female, aged ≥18 and 30).
  • The subject has a known history of heart disease, lung disease, kidney or liver disease.
  • Diagnosis of asthma, sleep apnea, or use of CPAP.
  • Subject has diabetes.
  • Subject has a clotting disorder.
  • The subject has a hemoglobinopathy or history of anemia, per subject report or the first blood sample, that in the opinion of the investigator, would make them unsuitable for study participation.
  • The subject has any other serious systemic illness.
  • The subject is a current smoker.
  • Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators' would interfere with the sensors working correctly.
  • The subject has a history of fainting or vasovagal response.
  • The subject has a history of sensitivity to local anesthesia or allergy to the study drugs.
  • The subject has a diagnosis of Raynaud's disease.
  • The subject has unacceptable collateral circulation based on exam by the investigator (Allen's test).
  • The subject is pregnant, lactating or trying to get pregnant.
  • The subject has a history of migraine headaches.
  • The subject is currently taking antidepressants.
  • The subject is unable or unwilling to provide informed consent, or is unable or unwilling to comply with study procedures.
  • The subject has any other condition, which in the opinion of the investigators' would make them unsuitable for the study.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03125005). 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.

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