INVSENSOR00032 and INVSENSOR00033 Respiration Rate Clinical Performance Study

NCT03897179 | Completed Results FDA Device

• 1 other identifier: TP-19608
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• RRp Arms of Sensor Accuracy

  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.

  1-5 hours

Study Arms (1)

INVSENSOR00032 and INVSENSOR00033 test group

EXPERIMENTAL

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

Device: INVSENSOR00032 and INVSENSOR00033

Interventions

INVSENSOR00032 and INVSENSOR00033 DEVICE

Investigational pulse oximeter device

INVSENSOR00032 and INVSENSOR00033 test group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

• 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

Sponsors & Collaborators

• Masimo Corporation: lead

Study Sites (1)

Masimo Corporation

Irvine, California, 92618, United States

Location

Results Point of Contact

• Title: Ahmed Alghazi
• Organization: Masimo

studies@masimo.com

949-297-7000

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2019
• First Posted: April 1, 2019
• Study Start: February 13, 2019
• Primary Completion: February 25, 2019
• Study Completion: February 25, 2019
• Last Updated: March 27, 2020
• Results First Posted: March 27, 2020

Record last verified: 2020-03

Locations

US (1)