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INVSENSOR00013 Respiratory Rate Clinical Performance Study

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. Identifier: NCT03440619
Recruitment Status : Completed
First Posted : February 21, 2018
Results First Posted : April 23, 2019
Last Update Posted : April 23, 2019
Information provided by (Responsible Party):
Masimo Corporation

Brief Summary:
The objective of this prospective study is to compare the noninvasive respiration from pleth (RRp) performance of the Masimo INVSENSOR00013 device against the respiratory rate measured by capnography (RRref), Masimo's RAM technology and the manual annotation.

Condition or disease Intervention/treatment Phase
Healthy Device: INVSENSOR00013 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: INVSENSOR00013 Respiratory Rate Clinical Performance Study
Actual Study Start Date : February 6, 2018
Actual Primary Completion Date : February 14, 2018
Actual Study Completion Date : February 14, 2018

Arm Intervention/treatment
Experimental: INVSENSOR00013 Test group
All subjects will be enrolled into the test group and will receive the INVSENSOR00013 investigational device.
Device: INVSENSOR00013
Investigational pulse oximeter device that will be placed on the subject's finger. This will be used as a spotcheck device

Primary Outcome Measures :
  1. RRp Arms of Sensor Accuracy [ Time Frame: 1-5 hours ]
    Accuracy will be determined by comparing the noninvasive respiratory rate by pleth (RRp) measurement of the INVSENSOR00013 to the respiratory rate reference (RRef) and calculating the arithmetic root mean square (Arms) value. In order to obtain the Arms value, the RR measurement from the reference is subtracted from the INVSENSOR00013 RRp measurement 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 value.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 18 to 70 years old
  • Physical status of ASA I or II
  • Must be able to read and communicate in English
  • Has signed all necessary related documents, e.g. written informed consent, confidentiality agreement
  • Passed health assessment screening
  • Negative pregnancy test for female subjects of child bearing potential

Exclusion Criteria:

  • Physical status of ASA III, IV, or V
  • Subject has any medical condition which in the judgement of the investigator, renders them inappropriate for participation in the study
  • Inability to tolerate sitting still or minimal movement for at least 30 minutes
  • Positive pregnancy test for female subjects
  • Refusal to take pregnancy test for women of child bearing potential
  • Nursing female subjects
  • Refusal of male subjects to agree to shave hair off areas where the sensor will be applied (neck) when deemed necessary
  • Subjects wearing acrylic nails or subjects refusing to remove nail polish
  • Subjects who have a nail deformity on the measurement finger
  • Subjects who do not have adequate skin integrity on the measurement finger
  • Excluded at the Principal Investigator's discretion

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 identifier (NCT number): NCT03440619

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United States, California
Masimo Clinical Lab
Irvine, California, United States, 92618
Sponsors and Collaborators
Masimo Corporation
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Principal Investigator: Ahmed Alghazi, M.D. Masimo Corporation
  Study Documents (Full-Text)

Documents provided by Masimo Corporation:

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Responsible Party: Masimo Corporation Identifier: NCT03440619     History of Changes
Other Study ID Numbers: TP-18896
First Posted: February 21, 2018    Key Record Dates
Results First Posted: April 23, 2019
Last Update Posted: April 23, 2019
Last Verified: April 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
Pediatric Postmarket Surveillance of a Device Product: No