An observational study in Pulmonary Hypertension, sponsored by Air Liquide Santé International. Completed at 14 sites in 2 countries. Open to participants aged 1 Day and older. Per ClinicalTrials.gov, last updated 2016-07-01.
Sponsored by Air Liquide Santé International (part of Air Liquide) · Observational
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.
This study is intended to describe daily practice and therefore, there is not a standardized protocol but only patient-based and site-based questionnaires.
1,119 studies on the registry are indexed under Hypertension, Pulmonary; 236 are open to participants now.
This study's enrollment of 239 is above the median of 117 across 389 observational studies indexed under Hypertension, Pulmonary.
Browse Hypertension, Pulmonary studies →Air Liquide Santé International is the lead sponsor of 23 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
patients with PAH associated with heart surgery or PPHN
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
iNO characteristics of administration:doses, ventilation mode,concomitant pulmonary vasodilator treatments
Data collected by questionnaire
Time frame: Through iNO administration, an average of 4 days
Profile of patients: age, gender, disease characteristics.
Data collected by questionnaire
Time frame: 1 day
Number and percentage of patients with adverse events
Time frame: During iNO administration, an average of 4 days
Number and percentage of patients with adverse drug reaction
As no adverse drug reaction occured during this study, no specific data on time frame can be implemented
Time frame: From 1h after the end of iNO administration up to 28 days after ICU discharge
Investigator's opinion regarding EZ-KINOX use
Data collected by questionnaire
Time frame: Through iNO administration, an average of 4 days
This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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