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Trial record 26 of 619 for:    oximeter

Spot-Check Noninvasive Pulse CO-Oximeter Validation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02782806
Recruitment Status : Completed
First Posted : May 25, 2016
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
Masimo Corporation

Brief Summary:
In this study, the accuracy of a noninvasive hemoglobin sensor(s) will be assessed by comparison to hemoglobin measurements from a laboratory analyzer.

Condition or disease Intervention/treatment Phase
Anemia Device: Masimo Rad-67 Pulse Oximeter Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 368 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation
Actual Study Start Date : April 11, 2016
Actual Primary Completion Date : May 19, 2016
Actual Study Completion Date : May 19, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rashes

Arm Intervention/treatment
Experimental: Test group
All subjects are enrolled into the test group and receive Masimo Rad-67 Pulse Oximeter for measurement of hemoglobin.
Device: Masimo Rad-67 Pulse Oximeter
Noninvasive pulse oximeter




Primary Outcome Measures :
  1. Accuracy of sensor [ Time Frame: Up to 1 hr per subject ]
    Accuracy willl be determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square(Arms) error value.



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female
  • Age: Greater than one month
  • Weight: Greater than or equal to 3kg
  • Any racial or ethnic group
  • The subject or the subject's legally authorized representative has given written informed consent/assent to participate in the study
  • If an ICU patient, total hemoglobin of < 9 g/dL at time of screening.

Exclusion Criteria:

  • 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 burns, scar tissue, nail polish, acrylic nails, infections, abnormalities, etc.
  • Subjects deemed not suitable for the study at the discretion of the investigator
  • 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.

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): NCT02782806


Locations
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United States, California
Masimo Corporation
Irvine, California, United States, 92618
Sponsors and Collaborators
Masimo Corporation

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Responsible Party: Masimo Corporation
ClinicalTrials.gov Identifier: NCT02782806     History of Changes
Other Study ID Numbers: TORR0001
First Posted: May 25, 2016    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Keywords provided by Masimo Corporation:
Noninvasive
Pulse
CO-Oximeter
Validation