Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Hemodilution Validation of INVSENSOR00026

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03677375
Recruitment Status : Completed
First Posted : September 19, 2018
Results First Posted : May 20, 2019
Last Update Posted : May 20, 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: INVSENSOR00026
Enrollment 173
Recruitment Details  
Pre-assignment Details Protocol enrollment number includes screen failures and subjects that did not proceed due to time constraints
Arm/Group Title Test Subject
Hide Arm/Group Description

All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00026.

INVSENSOR00026: Noninvasive pulse oximeter sensor

Period Title: Overall Study
Started 93
Completed 81
Not Completed 12
Reason Not Completed
Incomplete procedure             8
Adverse Event             3
Physician Decision             1
Arm/Group Title Test Subject
Hide Arm/Group Description

All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00026.

INVSENSOR00026: Noninvasive pulse oximeter sensor

Overall Number of Baseline Participants 40
Hide Baseline Analysis Population Description
Subjects whose hemoglobin levels did not meet predefined study requirements were not included in the final data analysis.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
<=18 years
0
   0.0%
Between 18 and 65 years
40
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
Female
31
  77.5%
Male
9
  22.5%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
Asian or Pacific Islander
4
  10.0%
Caucasian
15
  37.5%
Black or African American
12
  30.0%
Hispanic
9
  22.5%
1.Primary Outcome
Title Accuracy of Noninvasive Hemoglobin Sensor by Arms Calculation
Hide Description Accuracy will be determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square (Arms) error value. In order to obtain the Arms value, the blood sample hemoglobin value is subtracted from the pulse oximeter 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 1-5 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Test Subject
Hide Arm/Group Description:

All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00026.

INVSENSOR00026: Noninvasive pulse oximeter sensor

Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: g/dL
1.13
Time Frame 5 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Test Subject
Hide Arm/Group Description

All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00026.

INVSENSOR00026: Noninvasive pulse oximeter sensor

All-Cause Mortality
Test Subject
Affected / at Risk (%)
Total   0/93 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Test Subject
Affected / at Risk (%)
Total   0/93 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Test Subject
Affected / at Risk (%)
Total   8/93 (8.60%) 
Injury, poisoning and procedural complications   
Swelling due to IV catheter site infiltration *  2/93 (2.15%) 
Vasovagal episode during arterial line placement *  1/93 (1.08%) 
Numbness secondary to local anesthetic infiltration *  1/93 (1.08%) 
Bruising and swelling at arterial site *  2/93 (2.15%) 
Headache *  1/93 (1.08%) 
Discomfort *  1/93 (1.08%) 
*
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: Tala Harake
Organization: Masimo
Phone: 9492977000
EMail: studies@masimo.com
Layout table for additonal information
Responsible Party: Masimo Corporation
ClinicalTrials.gov Identifier: NCT03677375     History of Changes
Other Study ID Numbers: TP-19466
First Submitted: September 17, 2018
First Posted: September 19, 2018
Results First Submitted: April 19, 2019
Results First Posted: May 20, 2019
Last Update Posted: May 20, 2019