N/A
Completed N=118
Accuracy of Hemoglobin Measurement for Various Rainbow Pulse Oximeter Sensors
Healthy
Source: ClinicalTrials.gov NCT03124966 ↗
Enrolled (actual)
118
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcomePrimary: Accuracy of Sensor by Arms Calculation — 0.96 g/dL
Summary
In this study, the concentration of hemoglobin within the subject's blood will be reduced in a controlled manner by administering fluids intravenously. The accuracy of a noninvasive hemoglobin sensor(s) will be assessed by comparison to hemoglobin measurements from a laboratory analyzer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Accuracy of Sensor by Arms Calculation |
0.96 | — |
Eligibility Criteria
Study Site 1:
Inclusion Criteria
- Has physical status between ASA 1 or 2
- Able to communicate in English
Exclusion Criteria
- Pregnant or sexually active without birth control.
- Hemoglobin less than 11g/dL
- Known alcohol or drug abuse
- Skin abnormalities affecting the digits such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection
- Nail polish
- Head injury with loss of consciousness within the last year
- Known neurological and psychiatric conditions.
- Known concurrent chronic usage of psychoactive or anti-convulsive drugs within the last 90 days, or use in the last 7 days (i.e. tricyclic antidepressants, MAO inhibitors, lithium, neuroleptics, anxiolytics or antipsychotics. Except SSRIs
- Subject has any medical condition which, in the judgement of the investigator, renders them inappropriate for participation in this study, such as Raynaud's syndrome
- Hypertension: Systolic BP >= 140 mmHg or Diastolic BP >= 90 mmHg
- Baseline heart rate 140 mmHg or Diastolic BP > 90 mmHg.
- Baseline heart rate < 50 bpm.
- Inability to tolerate sitting still or minimal movement for up to 90 minutes
Data sourced from ClinicalTrials.gov (NCT03124966). 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.