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INVSENSOR00013 Respiratory Rate Clinical Performance Study

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ClinicalTrials.gov Identifier: NCT03440619
Recruitment Status : Completed
First Posted : February 21, 2018
Results First Posted : April 23, 2019
Last Update Posted : April 23, 2019
Sponsor:
Information provided by (Responsible Party):
Masimo Corporation

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Healthy
Intervention Device: INVSENSOR00013
Enrollment 28
Recruitment Details  
Pre-assignment Details  
Arm/Group Title INVSENSOR00013 Sensor
Hide Arm/Group Description All subjects are enrolled into the test group and all subjects received the INVSENSOR00013 sensor.
Period Title: Overall Study
Started 28
Completed 28
Not Completed 0
Arm/Group Title INVSENSOR00013 Sensor
Hide Arm/Group Description All subjects are enrolled into the test group and all subjects received the INVSENSOR00013 sensor.
Overall Number of Baseline Participants 28
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
<=18 years
0
   0.0%
Between 18 and 65 years
28
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
Female
9
  32.1%
Male
19
  67.9%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
African American
9
  32.1%
Asian or Pacific Islander
2
   7.1%
Caucasian
9
  32.1%
Hispanic
7
  25.0%
Other
1
   3.6%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 28 participants
28
 100.0%
1.Primary Outcome
Title RRp Arms of Sensor Accuracy
Hide Description 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.
Time Frame 1-5 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title INVSENSOR00013 Sensor
Hide Arm/Group Description:
All subjects are enrolled into the test group and received one INVSENSOR00013 sensor.
Overall Number of Participants Analyzed 28
Measure Type: Number
Unit of Measure: respiration per minute (RPM)
1.2
Time Frame Adverse event data was collected over the course of the study (9 days).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title INVSENSOR00013 Sensor
Hide Arm/Group Description All subjects are enrolled into the test group and received the INVSENSOR00013 sensor.
All-Cause Mortality
INVSENSOR00013 Sensor
Affected / at Risk (%)
Total   0/28 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
INVSENSOR00013 Sensor
Affected / at Risk (%)
Total   0/28 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
INVSENSOR00013 Sensor
Affected / at Risk (%)
Total   0/28 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ahmed Alghazi
Organization: Masimo
Phone: 949-297-7000
EMail: studies@masimo.com
Layout table for additonal information
Responsible Party: Masimo Corporation
ClinicalTrials.gov Identifier: NCT03440619     History of Changes
Other Study ID Numbers: TP-18896
First Submitted: February 14, 2018
First Posted: February 21, 2018
Results First Submitted: February 25, 2019
Results First Posted: April 23, 2019
Last Update Posted: April 23, 2019