NCT02821156

Study on the Use of Inhaled NO (iNO)

Prospective Observational Study on the Use of Inhaled NO (iNO) Administered Through an Integrated deliVEry and Monitoring Device EZ-KINOX

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 239 (actual)
• Sponsor: Air Liquide Santé International · Industry
• Sex: All
• Age: 1 Day
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Pulmonary Hypertension

Interventions

Type	Name	Description
DRUG	—	Inhaled Nitric Oxide with monitoring by EZ-KINOX device

Timeline

• Start date: 2014-09-01
• Primary completion: 2015-09-01
• Completion: 2015-10-01
• First posted: 2016-07-01
• Last updated: 2016-07-01

Locations

14 sites across 2 countries: Belgium, France