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Accuracy of Noninvasive Pulse Oximeter Sensor (Rainbow DCI)

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: NCT03124823
Recruitment Status : Completed
First Posted : April 24, 2017
Results First Posted : July 28, 2017
Last Update Posted : July 28, 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 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
No text entered.

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 Subject All subjects are enrolled into the test group and all subjects received the Rainbow DCI Sensor

Participant Flow:   Overall Study
    Test Subject
STARTED   11 
COMPLETED   11 
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.
No text entered.

Reporting Groups
  Description
Test Subject All subjects are enrolled into the test group and all subjects received the Rainbow DCI Sensor

Baseline Measures
   Test Subject 
Overall Participants Analyzed 
[Units: Participants]
 11 
Age, Customized 
[Units: Participants]
Count of Participants
 
24-43 years   11 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      4  36.4% 
Male      7  63.6% 


  Outcome Measures

1.  Primary:   Accuracy of Sensor by Arms Calculation   [ Time Frame: 1-5 hours ]


  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: NCT03124823     History of Changes
Other Study ID Numbers: TR29866-TP17699A
First Submitted: April 14, 2017
First Posted: April 24, 2017
Results First Submitted: May 8, 2017
Results First Posted: July 28, 2017
Last Update Posted: July 28, 2017