MightySat - Clinical Performance Comparison Study

NCT03239574 | Completed Results

• 1 other identifier: TP-18810A
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Accuracy of RRp Determination

  Accuracy will be determined by comparing the noninvasive respiratory rate by pleth (RRp) measurement of the MightySat to the respiratory rate (RR) reference and calculating the arithmetic root mean square error (Arms) value. In order to obtain the Arms value, the RR measurement from the reference is subtracted from the MightySat 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 Error value.

  approximately 30-40 minutes

Study Arms (1)

MightySat Test group

EXPERIMENTAL

The subjects will be enrolled into the test group and will receive the MightySat investigational pulse oximeter.

Device: MightySat

Interventions

MightySat DEVICE

MightySat - investigational pulse oximeter that will be placed on the subject's right index finger for the duration of the study

MightySat Test group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

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

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2017
• First Posted: August 4, 2017
• Study Start: July 10, 2017
• Primary Completion: July 20, 2017
• Study Completion: July 20, 2017
• Last Updated: December 31, 2020
• Results First Posted: December 31, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)