Spot analysis of hemoglobin through Pulse CO-Oximeter
Not Applicable
- Conditions
- Health Condition 1: D571- Sickle-cell disease without crisisHealth Condition 2: D569- Thalassemia, unspecified
- Registration Number
- CTRI/2022/10/046378
- Lead Sponsor
- Masimo Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Weight >3kg
Exclusion Criteria
• Skin abnormalities at the planned application sites that may interfere with sensor application, per directions-for-use (DFU) or trans-illumination of the site, such as psoriasis, eczema, angioma, burns, scar tissue, substantial skin breakdown, nail polish, acrylic nails, infections, abnormalities, etc. • Subjects deemed not suitable for the study at the discretion of the investigator
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method oninvasive hemoglobin measurement (SpHb) using Masimo Pulse CO-Oximeter device and sensor in a variety subjects, including pediatric subjects, pregnant and non-pregnant adults, healthy individuals and sick patients, with hemoglobin range spanning from 3-18 g/dL .Timepoint: 10 minutes interval
- Secondary Outcome Measures
Name Time Method on invasive hemoglobin(SpHb) using Masimo Pulse Co-oximeter before Invasive measurement of Hemoglobin by Blood draw with atleast 15 minutes gap between these two measurements.Timepoint: Spot check analysis at an interval of 15 minutes between invasive and non-invasive measurement.