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

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ClinicalTrials.gov Identifier: NCT03610269
Recruitment Status : Completed
First Posted : August 1, 2018
Results First Posted : June 25, 2019
Last Update Posted : June 25, 2019
Sponsor:
Information provided by (Responsible Party):
Masimo Corporation

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Anemia Device: INVSENSOR00026 (Pulse CO-Oximeter and sensor) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 143 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation of INVSENSOR00026
Actual Study Start Date : August 1, 2018
Actual Primary Completion Date : August 16, 2018
Actual Study Completion Date : August 16, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rashes

Arm Intervention/treatment
Experimental: INVSENSOR00026
All enrolled subjects receive INVSENSOR00026 Pulse CO-Oximeter and sensor for the noninvasive measurement of hemoglobin (SpHb).
Device: INVSENSOR00026 (Pulse CO-Oximeter and sensor)
Noninvasive Pulse CO-Oximeter and sensor that measures noninvasive hemoglobin (SpHb)




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03610269


Locations
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United States, California
Torrance Clinical Research
Lomita, California, United States, 90717
Sponsors and Collaborators
Masimo Corporation
  Study Documents (Full-Text)

Documents provided by Masimo Corporation:

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Responsible Party: Masimo Corporation
ClinicalTrials.gov Identifier: NCT03610269     History of Changes
Other Study ID Numbers: TORR0003
First Posted: August 1, 2018    Key Record Dates
Results First Posted: June 25, 2019
Last Update Posted: June 25, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No