MightySat - Clinical Performance Comparison Study

Completed

Conditions studied: Healthy

In brief

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 breaths per minute.

Key facts

Study ID

NCT03239574

Run by

Masimo Corporation

People needed

34

Starts

2017-07-10

Expected to finish

2017-07-20

Last updated by the study team

2020-12-31

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Masimo Clinical Lab — Irvine, California, United States

Full record on ClinicalTrials.gov

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