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Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation of INVSENSOR00026

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ClinicalTrials.gov Identifier: NCT03610269
Recruitment Status : Completed
First Posted : August 1, 2018
Results First Posted : June 25, 2019
Last Update Posted : June 25, 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 Anemia
Intervention Device: INVSENSOR00026 (Pulse CO-Oximeter and sensor)
Enrollment 143
Recruitment Details  
Pre-assignment Details  
Arm/Group Title INVSENSOR00026
Hide Arm/Group Description All enrolled subjects receive INVSENSOR00026 Pulse CO-Oximeter and sensor for the noninvasive measurement of hemoglobin (SpHb).
Period Title: Overall Study
Started 143
Completed 127
Not Completed 16
Reason Not Completed
Physician Decision             10
Protocol Violation             1
Unable to draw blood             1
Screen fail             4
Arm/Group Title INVSENSOR00026
Hide Arm/Group Description All enrolled subjects receive INVSENSOR00026 Pulse CO-Oximeter and sensor for the noninvasive measurement of hemoglobin (SpHb).
Overall Number of Baseline Participants 111
Hide Baseline Analysis Population Description
Number of baseline participants excludes data from subjects with protocol deviations or those with insufficient blood sample volume.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 111 participants
<=18 years
0
   0.0%
Between 18 and 65 years
101
  91.0%
>=65 years
10
   9.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 111 participants
Female
68
  61.3%
Male
43
  38.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 111 participants
American Indian or Alaska Native
1
   0.9%
Asian
1
   0.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
3
   2.7%
White
106
  95.5%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 111 participants
111
1.Primary Outcome
Title Accuracy of Noninvasive Hemoglobin (SpHb) Measurement by Arms Calculation
Hide Description Accuracy of the INVSENSOR00026 will be determined by comparing the noninvasive hemoglobin measurement (SpHb) of the INVSENSOR00026 to the hemoglobin value obtained from a reference blood sample and calculating the accuracy root mean square (Arms) error value. In order to obtain the Arms value, the blood sample hemoglobin value is subtracted from the INVSENSOR00026 hemoglobin value 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.
Time Frame Up to 2 hours per subject
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title INVSENSOR00026
Hide Arm/Group Description:
All enrolled subjects receive INVSENSOR00026 Pulse CO-Oximeter and sensor for the noninvasive measurement of hemoglobin (SpHb).
Overall Number of Participants Analyzed 111
Measure Type: Number
Unit of Measure: g/dL
0.93
Time Frame During the duration of the study and 2 weeks after participation in the study.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title INVSENSOR00026
Hide Arm/Group Description All enrolled subjects receive INVSENSOR00026 Pulse CO-Oximeter and sensor for the noninvasive measurement of hemoglobin (SpHb).
All-Cause Mortality
INVSENSOR00026
Affected / at Risk (%)
Total   0/127 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
INVSENSOR00026
Affected / at Risk (%)
Total   0/127 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
INVSENSOR00026
Affected / at Risk (%)
Total   2/127 (1.57%) 
Injury, poisoning and procedural complications   
Vasovagal syncope *  1/127 (0.79%) 
Hematoma *  1/127 (0.79%) 
*
Indicates events were collected by non-systematic assessment
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: Vikram Ramakanth
Organization: Masimo
Phone: 949-297-7416
EMail: clinicalresearchdept@masimo.com
Layout table for additonal information
Responsible Party: Masimo Corporation
ClinicalTrials.gov Identifier: NCT03610269     History of Changes
Other Study ID Numbers: TORR0003
First Submitted: July 26, 2018
First Posted: August 1, 2018
Results First Submitted: April 19, 2019
Results First Posted: June 25, 2019
Last Update Posted: June 25, 2019