Nitric Oxide, GeNO Nitrosyl Delivery System

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jackie Blundon, MS, CIP, Aurora Health Care
ClinicalTrials.gov Identifier:
NCT01165047
First received: July 16, 2010
Last updated: August 21, 2014
Last verified: August 2014
Results First Received: August 7, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Pulmonary Arterial Hypertension
Intervention: Drug: Nitric Oxide

  Participant Flow
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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
Nitric Oxide

80 ppm in air or oxygen will be administered using the GeNO nitrosyl delivery system with a standard nasal cannula at a flow rate of 4 LPM

Nitric Oxide: Nitric oxide, 80 ppm in air or oxygen will be administered using the GeNO nitrosyl delivery system with a standard nasal cannula at a flow rate of 4 LPM.


Participant Flow:   Overall Study
    Nitric Oxide  
STARTED     10  
COMPLETED     10  
NOT COMPLETED     0  



  Baseline Characteristics
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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
Nitric Oxide

80 ppm in air or oxygen will be administered using the GeNO nitrosyl delivery system with a standard nasal cannula at a flow rate of 4 LPM

Nitric Oxide: Nitric oxide, 80 ppm in air or oxygen will be administered using the GeNO nitrosyl delivery system with a standard nasal cannula at a flow rate of 4 LPM.


Baseline Measures
    Nitric Oxide  
Number of Participants  
[units: participants]
  10  
Age, Customized [1]
[units: participants]
 
equal or greater than 18     10  
Gender  
[units: participants]
 
Female     2  
Male     8  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     1  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     5  
White     3  
More than one race     0  
Unknown or Not Reported     1  
Region of Enrollment  
[units: participants]
 
United States     10  
[1] >= 18 years



  Outcome Measures

1.  Primary:   Number of Participants With Side Effects and/or Adverse Events   [ Time Frame: 5 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Katernie Slotke
Organization: Aurora Health Care
phone: 414-649-2615
e-mail: katherine.Slotke@aurora.org


No publications provided


Responsible Party: Jackie Blundon, MS, CIP, Aurora Health Care
ClinicalTrials.gov Identifier: NCT01165047     History of Changes
Other Study ID Numbers: 1.0
Study First Received: July 16, 2010
Results First Received: August 7, 2014
Last Updated: August 21, 2014
Health Authority: United States: Food and Drug Administration