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Accuracy of Noninvasive Hemoglobin Sensor (Rainbow Reusable DCI)

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ClinicalTrials.gov Identifier: NCT03124758
Recruitment Status : Completed
First Posted : April 24, 2017
Results First Posted : June 6, 2017
Last Update Posted : July 27, 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
Condition: Healthy
Intervention: Device: Hemoglobin Sensor ((Rainbow Reusable DCI, DCIP))

  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
Noninvasive Hemoglobin Sensor All subjects are enrolled into the test group and all subjects received the Noninvasive Hemoglobin Sensor (Rainbow Reusable DCI, DCIP)

Participant Flow:   Overall Study
    Noninvasive Hemoglobin Sensor
STARTED   354 
COMPLETED   354 
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
Noninvasive Hemoglobin Sensor All subjects are enrolled into the test group and all subjects received the Noninvasive Hemoglobin Sensor (Rainbow Reusable DCI, DCIP)

Baseline Measures
   Noninvasive Hemoglobin Sensor 
Overall Participants Analyzed 
[Units: Participants]
 354 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      354 100.0% 
>=65 years      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      127  35.9% 
Male      227  64.1% 


  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: NCT03124758     History of Changes
Other Study ID Numbers: TR24577-TP15879-TP14065
First Submitted: April 14, 2017
First Posted: April 24, 2017
Results First Submitted: May 8, 2017
Results First Posted: June 6, 2017
Last Update Posted: July 27, 2017