INVSENSOR00032 and INVSENSOR00033 Respiration Rate Clinical Performance Study

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Device: INVSENSOR00032 and INVSENSOR00033

• Registration Number: NCT03897179
• Lead Sponsor: Masimo Corporation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-13
• Primary Completion: 2019-02-25
• Study Completion: 2019-02-25
• Study First Submitted: 2019-03-20
• Study First Submitted QC: 2019-03-28
• Study First Posted: 2019-04-01
• Status Verified: 2020-03
• Results First Submitted: 2020-03-13
• Results First Submitted QC: 2020-03-13
• Last Update Submitted: 2020-03-13
• Results First Posted: 2020-03-27
• Last Update Posted: 2020-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
INVSENSOR00032 and INVSENSOR00033 test group	INVSENSOR00032 and INVSENSOR00033	All subjects will be enrolled into the test group and will receive the INVSENSOR00032 and/or INVSENSOR00033 device.

Primary Outcome Measures

Name	Time	Method
RRp Arms of Sensor Accuracy	1-5 hours	Accuracy will be determined by comparing the noninvasive respiratory rate by pleth (RRp) measurement of the INVSENSOR00032 and/or INVSENSOR00033 to the respiratory rate reference (RRef) and calculating the arithmetic root mean square (Arms) value. In order to obtain the Arms value, the RR measurement from the reference is subtracted from the INVSENSOR00032 and/or INVSENSOR00033 RRp measurement for a number of samples. The average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms value.

Trial Locations

Locations (1)

Masimo Corporation; 🇺🇸 Irvine, California, United States