Nitric Oxide, GeNO Nitrosyl Delivery System
This study has been completed.
Sponsor:
Aurora Health Care
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
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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
Hide 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 |
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| 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
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
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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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| No text entered. |
More Information
Certain Agreements:
Results Point of Contact:
| 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
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 |
| 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 |