INVSENSOR00013 Respiratory Rate Clinical Performance Study

NCT03440619 | Completed Results FDA Device

• 1 other identifier: TP-18896
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this prospective study is to compare the noninvasive respiration from pleth (RRp) performance of the Masimo INVSENSOR00013 device against the respiratory rate measured by capnography (RRref), Masimo's RAM technology and the manual annotation.

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 INVSENSOR00013 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 INVSENSOR00013 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)

INVSENSOR00013 Test group

EXPERIMENTAL

All subjects will be enrolled into the test group and will receive the INVSENSOR00013 investigational device.

Device: INVSENSOR00013

Interventions

INVSENSOR00013 DEVICE

Investigational pulse oximeter device that will be placed on the subject's finger. This will be used as a spotcheck device

INVSENSOR00013 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:

• to 70 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

You may not qualify if:

• Physical status of ASA III, IV, or 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 the sensor will be applied (neck) when deemed necessary
• 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 Clinical Lab

Irvine, California, 92618, United States

Location

Results Point of Contact

• Title: Ahmed Alghazi
• Organization: Masimo

studies@masimo.com

949-297-7000

Study Officials

• Ahmed Alghazi, M.D.

  Masimo Corporation

  PRINCIPAL INVESTIGATOR

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: February 14, 2018
• First Posted: February 22, 2018
• Study Start: February 6, 2018
• Primary Completion: February 14, 2018
• Study Completion: February 14, 2018
• Last Updated: April 23, 2019
• Results First Posted: April 23, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)