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Desaturation Validation of INVSENSOR00031

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ClinicalTrials.gov Identifier: NCT03783780
Recruitment Status : Completed
First Posted : December 21, 2018
Results First Posted : July 2, 2019
Last Update Posted : July 2, 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: INVSENSOR00031
Enrollment 46
Recruitment Details  
Pre-assignment Details  
Arm/Group Title INVSENSOR00031
Hide Arm/Group Description All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00031 sensor during motion and non-motion.
Period Title: Overall Study
Started 21
Completed 20
Not Completed 1
Reason Not Completed
Withdrawn prior to completion             1
Arm/Group Title INVSENSOR00031
Hide Arm/Group Description All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00031 sensor during motion and non-motion.
Overall Number of Baseline Participants 21
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
<=18 years
0
   0.0%
Between 18 and 65 years
20
 100.0%
>=65 years
0
   0.0%
[1]
Measure Analysis Population Description: One subject was withdrawn prior to completing study procedures.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
11
  55.0%
Male
9
  45.0%
[1]
Measure Analysis Population Description: One subject was withdrawn prior to completing study procedures.
Race/Ethnicity, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
White Number Analyzed 20 participants
10
  50.0%
Hispanic Number Analyzed 20 participants
5
  25.0%
Asian or Pacific Islander Number Analyzed 20 participants
2
  10.0%
African American Number Analyzed 20 participants
3
  15.0%
[1]
Measure Analysis Population Description: One subject was withdrawn prior to completion of study procedures.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 21 participants
21
1.Primary Outcome
Title Oxygen Saturation (SpO2) Accuracy of Sensor by Arms Calculation During Non-motion
Hide Description Performance of the sensors will be determined by comparing the noninvasive oxygen saturation measurement (SpO2) of the pulse oximeter sensors to the arterial oxygen saturation (SaO2) value obtained from a reference blood sample and calculating the Arithmetic root mean square (ARMS) value during non-motion.
Time Frame 1-5 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Only ten subjects, out of the 20 who participated in the study, underwent testing for this non-motion outcome measure.
Arm/Group Title INVSENSOR00031
Hide Arm/Group Description:
All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00031 sensor.
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: % of oxygen saturated hemoglobin
1.33
2.Secondary Outcome
Title Oxygen Saturation (SpO2) Accuracy of Sensor by Arms Calculation During Motion
Hide Description Performance of the sensors will be determined by comparing the noninvasive oxygen saturation measurement (SpO2) of the pulse oximeter sensors to the arterial oxygen saturation (SaO2) value obtained from a reference blood sample and calculating the Arithmetic root mean square (ARMS) value during motion.
Time Frame 1-5 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Ten subjects were excluded from data analysis from this outcome measure due to insufficient training of the study staff on the motion testing procedure.
Arm/Group Title INVSENSOR00031
Hide Arm/Group Description:

All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00031 sensor.

INVSENSOR00031: Noninvasive pulse oximeter sensor

Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: % of oxygen saturated hemoglobin
2.16
Time Frame 1 month
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title INVSENSOR00031
Hide Arm/Group Description All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00031 sensor during motion and non-motion.
All-Cause Mortality
INVSENSOR00031
Affected / at Risk (%)
Total   0/21 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
INVSENSOR00031
Affected / at Risk (%)
Total   0/21 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
INVSENSOR00031
Affected / at Risk (%)
Total   1/21 (4.76%) 
Injury, poisoning and procedural complications   
Scraped skin * [1]  1/21 (4.76%) 
*
Indicates events were collected by non-systematic assessment
[1]
Subjects skin was scraped with scissors, no visual abrasion
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: Tala Harake
Organization: Masimo
Phone: 1-949-297-7100
EMail: studies@masimo.com
Layout table for additonal information
Responsible Party: Masimo Corporation
ClinicalTrials.gov Identifier: NCT03783780     History of Changes
Other Study ID Numbers: TP-19564
First Submitted: December 19, 2018
First Posted: December 21, 2018
Results First Submitted: June 12, 2019
Results First Posted: July 2, 2019
Last Update Posted: July 2, 2019