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Spot analysis of Hemoglobin through Pulse CO-Oximeter

Spot Check SpHb Data Collection in Adult, Pediatric, and Pregnant Subjects

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/03/050699
Enrollment
2000
Registered
2023-03-14
Start date
Unknown
Completion date
Unknown
Last updated
2023-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: D500- Iron deficiency anemia secondary to blood loss (chronic)

Interventions

None listed

Sponsors

Masimo Corporation
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Weight >30 kg

Exclusion criteria

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, henna, acrylic nails, infections, abnormalities, etc. Subjects deemed not suitable for the study at the discretion of the investigator.

Design outcomes

Primary

MeasureTime frame
Noninvasive hemoglobin measurement (SpHb) using Masimo Rad 67 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/dlTimepoint: 10 minutes interval

Secondary

MeasureTime frame
Non 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.

Countries

India

Contacts

Public ContactDr Ashwini Kumar

Rajendra Institute of Medical Sciences

psmrims@gmail.com9523365695

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026