N/A Completed N=34 Other

MightySat - Clinical Performance Comparison Study

Healthy

Source: ClinicalTrials.gov NCT03239574 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2020

Primary outcomePrimary: Accuracy of RRp Determination — 1.9 breaths per minute

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Accuracy of RRp Determination	1.9	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.