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OpenTrials
Completed

NCT Number: NCT03610269

Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation of INVSENSOR00026

The primary objective of this clinical investigation is to evaluate the accuracy of using Masimo's INVSENSOR00026 Pulse CO-Oximeter and Sensor to measure hemoglobin, as compared to hemoglobin measurements obtained from various lab analyzer(s) and point of care device(s).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Torrance Clinical Research

Lomita, California, 90717, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years of age or older
  • Subject has given written informed consent to participate in the study

Exclusion criteria

  • (*) Pregnant or positive human chorionic gonadotropin (hCG) test
  • (*) Any severe coagulopathy, chronic bleeding disorders (i.e., hemophilia) or recent thrombolysis
  • (*) Hemoglobinopathies and synthesis disorders (i.e., sickle cell, thalassemias, etc.)
  • (*) Subjects who are currently taking anticoagulant medication
  • (*) Subjects with allergies to lidocaine, Pain Ease, latex, adhesives, or plastic
  • (*) Subjects with 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 unlikely to be able to refrain from excessive motion during data collection. Excessive motion includes postural changes, making hand gestures, involuntary muscular movements, etc.
  • (*) Subjects with elevated blood pressure, skin or wrist abnormalities that may interfere with an arterial blood draw as determined by investigator or research medical staff.
  • (*) Subjects who intend on participating in heavy lifting, repetitive movement of their wrist (including riding a motorcycle) or exercise (working out, riding a bike, etc.), or any activity that will put additional stress on the wrist within 24 hours following a study involving an arterial blood draw
  • Subjects deemed not suitable for the study at the discretion of the investigator or research medical staff

Note: (*) May be self-reported by subject

Treatment and study plan

INVSENSOR00026 (Pulse CO-Oximeter and sensor)

Device

Noninvasive Pulse CO-Oximeter and sensor that measures noninvasive hemoglobin (SpHb)

Primary outcomes

  1. Accuracy of Noninvasive Hemoglobin (SpHb) Measurement by Arms Calculation

    Time frame: Up to 2 hours per subject

    Accuracy of the INVSENSOR00026 will be determined by comparing the noninvasive hemoglobin measurement (SpHb) of the INVSENSOR00026 to the hemoglobin value obtained from a reference blood sample and calculating the accuracy root mean square (Arms) error value. In order to obtain the Arms value, the blood sample hemoglobin value is subtracted from the INVSENSOR00026 hemoglobin value for a number of samples, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value.

Sponsors and collaborators

Lead sponsor

Masimo Corporation

Industry

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 1, 2018
Registry last updated
Jun 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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