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Accuracy of Methemoglobin Measurement for Rainbow Universal Pulse Oximeter Sensor

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ClinicalTrials.gov Identifier: NCT03125005
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: Rainbow Universal 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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Rainbow Universal Pulse Oximeter Sensor

All subjects will be enrolled in the test group and will receive Rainbow Universal Pulse Oximeter Sensor.

Rainbow Universal Pulse Oximeter Sensor


Participant Flow:   Overall Study
    Rainbow Universal Pulse Oximeter Sensor
STARTED   51 
COMPLETED   51 
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
Rainbow Universal Pulse Oximeter Sensor

All subjects will be enrolled in the test group and will receive Rainbow Universal Pulse Oximeter Sensor.

Rainbow Universal Pulse Oximeter Sensor


Baseline Measures
   Rainbow Universal Pulse Oximeter Sensor 
Overall Participants Analyzed 
[Units: Participants]
 51 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      51 100.0% 
>=65 years      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      29  56.9% 
Male      22  43.1% 
Region of Enrollment 
[Units: Participants]
 
United States   51 


  Outcome Measures

1.  Primary:   Accuracy of Sensor by Arms Calculation   [ Time Frame: 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
No text entered.


  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: NCT03125005     History of Changes
Other Study ID Numbers: TR22640-BICK0001
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