INVSENSOR00032 and INVSENSOR00033 Respiration Rate Clinical Performance Study

Masimo

Status

Completed

Conditions

Healthy

Treatments

Device: INVSENSOR00032 and INVSENSOR00033

Study type

Interventional

Funder types

Industry

Identifiers

NCT03897179

TP-19608

Details and patient eligibility

About

This study compares the performance of respiration rate from pleth measured prospectively with either INVSENSOR00032 and/or INVSENSOR00033 devices against the respiration rate derived from the manual scoring of the capnography waveform in healthy adult subjects.

Enrollment

27 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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

Physical status of ASA III, IV, or V
Subject has any medical condition which in the judgment of the investigator, renders them inappropriate for participation in this 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
Subjects wearing acrylic nails or subjects refusing to remove nail polish
Subjects who have a nail deformity on the measurement finger
Subjects who do not have adequate skin integrity on the measurement finger
Excluded at the Principal Investigator's discretion