Prospective Observational Study on the Use of Inhaled NO (iNO) Administered Through an Integrated deliVEry and Monitoring Device EZ-KINOX
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 239
- Locations
- 13
- Primary Endpoint
- iNO characteristics of administration:doses, ventilation mode,concomitant pulmonary vasodilator treatments
Study Overview
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.
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 Design
- Study Type
- Observational
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 1 Day to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Newborn > or = to 34 weeks gestational age suffering from hypoxic respiratory failure with pulmonary hypertension (France only) or patient presenting post-operative pulmonary hypertension associated with cardiac surgery (France and Belgium) · Patient treated with iNO delivered with EZ-KINOX™
Exclusion Criteria
- •Newborn dependent on a right-to-left shunt or with a "malignant" left-right arterial canal
- •Newborn with Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency.
Outcomes
Primary Outcomes
iNO characteristics of administration:doses, ventilation mode,concomitant pulmonary vasodilator treatments
Time Frame: Through iNO administration, an average of 4 days
Data collected by questionnaire
Secondary Outcomes
- Number and percentage of patients with adverse events(During iNO administration, an average of 4 days)
- Investigator's opinion regarding EZ-KINOX use(Through iNO administration, an average of 4 days)
- Profile of patients: age, gender, disease characteristics.(1 day)
- Number and percentage of patients with adverse drug reaction(From 1h after the end of iNO administration up to 28 days after ICU discharge)