N/A
N=34
MightySat - Clinical Performance Comparison Study
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT03239574 ↗Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: Accuracy of RRp Determination — 1.9 breaths per minute
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- MightySat (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Masimo Corporation
- Primary completion
- Jul 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Accuracy of RRp Determination |
1.9 | — |
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 breaths per minute.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03239574). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.