Status:
COMPLETED
MightySat - Clinical Performance Comparison Study
Lead Sponsor:
Masimo Corporation
Conditions:
Healthy
Eligibility:
All Genders
18-45 years
Brief Summary
This study compares the performance of respiratory rate from pleth (RRp) measured with MightySat device on healthy subjects.Subjects will be asked to breathe at specific rates ranging from 5 to 30 bre...
Eligibility Criteria
Inclusion
- 18 to 45 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
- Younger than 18 years old, older than 45 years old
- 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
Key Trial Info
Start Date :
July 10 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 20 2017
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT03239574
Start Date
July 10 2017
End Date
July 20 2017
Last Update
December 31 2020
Active Locations (1)
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1
Masimo Clinical Lab
Irvine, California, United States, 92618