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Rainbow DCI vs. R1-25 Sensor SpHb Sub-Range Performance Equivalence

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: NCT03157232
Recruitment Status : Completed
First Posted : May 17, 2017
Results First Posted : July 27, 2017
Last Update Posted : July 27, 2017
Sponsor:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition: Healthy
Intervention: Device: Rainbow DCI and R1-25 sensor

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Test Group All subjects are enrolled into the test group and all subjects received both the Rainbow DCI and R1-25 sensor.

Participant Flow:   Overall Study
    Test Group
STARTED   18 
COMPLETED   18 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Test Group All subjects are enrolled into the test group and all subjects received both the Rainbow DCI and R1-25 sensor.

Baseline Measures
   Test Group 
Overall Participants Analyzed 
[Units: Participants]
 18 
Age, Customized 
[Units: Participants]
 
26-65 years   18 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      6  33.3% 
Male      12  66.7% 
Region of Enrollment 
[Units: Participants]
 
United States   18 


  Outcome Measures

1.  Primary:   Sub-Range Performance Equivalence of Rainbow DCI and R1-25 Sensors by ARMS Calculation   [ Time Frame: 1-5 hours per subject ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Tala Harake
Organization: Masimo
e-mail: studies@masimo.com



Responsible Party: Masimo Corporation
ClinicalTrials.gov Identifier: NCT03157232     History of Changes
Other Study ID Numbers: TR18695-TP14480
First Submitted: April 14, 2017
First Posted: May 17, 2017
Results First Submitted: May 19, 2017
Results First Posted: July 27, 2017
Last Update Posted: July 27, 2017