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Accuracy of Hemoglobin Measurement for Various Rainbow Pulse Oximeter Sensors

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ClinicalTrials.gov Identifier: NCT03124966
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: Pulse Oximeter 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
Noninvasive Hemoglobin Sensor All subjects are enrolled into the test group and all will receive the pulse oximeter sensor.

Participant Flow:   Overall Study
    Noninvasive Hemoglobin Sensor
STARTED   118 
COMPLETED   118 
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
Noninvasive Hemoglobin Sensor All subjects are enrolled into the test group and all will receive the pulse oximeter sensor.

Baseline Measures
   Noninvasive Hemoglobin Sensor 
Overall Participants Analyzed 
[Units: Participants]
 118 
Age 
[Units: Participants]
Count of Participants
 
Participants Analyzed   118 
<=18 years      0   0.0% 
Between 18 and 65 years      118 100.0% 
>=65 years      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Participants Analyzed   118 
Female      40  33.9% 
Male      78  66.1% 
Race and Ethnicity Not Collected [1] 
[Units: Participants]
Count of Participants
  
[1] Race and Ethnicity were not collected from any participant.
Region of Enrollment 
[Units: Participants]
 
United States   
Participants Analyzed   118 
United States   118 


  Outcome Measures

1.  Primary:   Accuracy of Sensor by Arms Calculation   [ Time Frame: 1-3 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:  
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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Vikram Ramakanth
Organization: Masimo
e-mail: clinicalresearchdept@masimo.com



Responsible Party: Masimo Corporation
ClinicalTrials.gov Identifier: NCT03124966     History of Changes
Other Study ID Numbers: TR19443-56044
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