Nitric Oxide, GeNO Nitrosyl Delivery System

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment; Masking: None (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
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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
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.
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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
Overall Participants Analyzed; [Units: Participants]	10
Age, Customized [1]; [Units: Participants]
equal or greater than 18	10
[1] >= 18 years
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

  Outcome Measures

1. Primary:

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

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  Serious Adverse Events

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  Other Adverse Events

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  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

Responsible Party:	Jackie Blundon, MS, CIP, Aurora Health Care
ClinicalTrials.gov Identifier:	NCT01165047 History of Changes
Other Study ID Numbers:	1.0
First Submitted:	July 16, 2010
First Posted:	July 19, 2010
Results First Submitted:	August 7, 2014
Results First Posted:	September 1, 2014
Last Update Posted:	September 1, 2014