Ignite Creation Date:
2024-05-06 @ 8:48 AM
Last Modification Date:
2024-10-26 @ 12:05 PM
Study NCT ID:
NCT02821156
Status:
COMPLETED
Last Update Posted:
2016-07-01
First Post:
2016-05-20
Brief Title:
Study on the Use of Inhaled NO iNO
Sponsor:
Air Liquide Santé International
Organization:
Air Liquide Santé International
Study Overview
Official Title:
Prospective Observational Study on the Use of Inhaled NO iNO Administered Through an Integrated deliVEry and Monitoring Device EZ-KINOX
Status:
COMPLETED
Status Verified Date:
2016-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
POSITIVE
Brief Summary:
This is a prospective observational multicenter study conducted during 1 year in adult and paediatric intensive care units equipped with the EZ-KINOX system
A maximum of 250 patients newborns to adults suffering from Pulmonary Arterial Hypertension PAH associated with cardiac surgery or Persistent Pulmonary Hypertension in the Newborn PPHN receiving iNO through the integrated delivery and monitoring EZ-KINOX system was planned to be included
The study is strictly non-interventional with the aim of describing current practices and therefore did not affect the patient usual management
A maximum of 250 patients newborns to adults suffering from Pulmonary Arterial Hypertension PAH associated with cardiac surgery or Persistent Pulmonary Hypertension in the Newborn PPHN receiving iNO through the integrated delivery and monitoring EZ-KINOX system was planned to be included
The study is strictly non-interventional with the aim of describing current practices and therefore did not affect the patient usual management
Detailed Description:
This study is intended to describe daily practice and therefore there is not a standardized protocol but only patient-based and site-based questionnaires
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None