Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
34 participants
INTERVENTIONAL
2017-07-10
2017-07-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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MightySat Test group
The subjects will be enrolled into the test group and will receive the MightySat investigational pulse oximeter.
MightySat
MightySat - investigational pulse oximeter that will be placed on the subject's right index finger for the duration of the study
Interventions
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MightySat
MightySat - investigational pulse oximeter that will be placed on the subject's right index finger for the duration of the study
Eligibility Criteria
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Inclusion Criteria
* 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
* ASA physical status of III, IV, and 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 sensors will be applied (neck)
* Excluded at Principal Investigator's discretion
18 Years
45 Years
ALL
Yes
Sponsors
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Masimo Corporation
INDUSTRY
Responsible Party
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Locations
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Masimo Clinical Lab
Irvine, California, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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TP-18810A
Identifier Type: -
Identifier Source: org_study_id