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Accuracy of Noninvasive Pulse Oximeter Measurement of Hemoglobin for Rainbow DCI Sensor

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ClinicalTrials.gov Identifier: NCT03124901
Recruitment Status : Completed
First Posted : April 24, 2017
Results First Posted : June 12, 2017
Last Update Posted : June 12, 2017
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
Conditions Surgery
Healthy
Intervention Device: DCI pulse oximeter sensor
Enrollment 147

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Test Group
Hide Arm/Group Description All subject are enrolled into the test group and all subjects receive DCI pulse oximeter sensor.
Period Title: Overall Study
Started 147
Completed 147
Not Completed 0
Arm/Group Title Test Group
Hide Arm/Group Description All subject are enrolled into the test group and all subjects receive DCI pulse oximeter sensor.
Overall Number of Baseline Participants 147
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 147 participants
<=18 years
0
   0.0%
Between 18 and 65 years
147
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 147 participants
Female
43
  29.3%
Male
104
  70.7%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 147 participants
147
1.Primary Outcome
Title Accuracy of Sensor
Hide Description Accuracy willl 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.
Time Frame Up to 24 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Test Group
Hide Arm/Group Description:
All subject are enrolled into the test group and all subjects receive DCI pulse oximeter sensor.
Overall Number of Participants Analyzed 147
Measure Type: Number
Unit of Measure: g/dL
0.98
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Test Group
Hide Arm/Group Description All subjects are enrolled into the test group and all subjects receive DCI pulse oximeter sensor.
All-Cause Mortality
Test Group
Affected / at Risk (%)
Total   0/147 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Test Group
Affected / at Risk (%)
Total   0/147 (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 Group
Affected / at Risk (%)
Total   0/147 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Vikram Ramakanth
Organization: Masimo
Responsible Party: Masimo Corporation
ClinicalTrials.gov Identifier: NCT03124901     History of Changes
Other Study ID Numbers: TR-17636-56044
First Submitted: April 11, 2017
First Posted: April 24, 2017
Results First Submitted: May 8, 2017
Results First Posted: June 12, 2017
Last Update Posted: June 12, 2017