Clinical trial NCT02821156: Study on the Use of Inhaled NO (iNO)
Official title: Prospective Observational Study on the Use of Inhaled NO (iNO) Administered Through an Integrated deliVEry and Monitoring Device EZ-KINOX
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Hypertension
Lead sponsor: Air Liquide Santé International
Sponsor class: INDUSTRY
Collaborators: name: Euraxi Pharma
First posted: 2016-07-01
Enrollment: 239
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with PAH associated with heart surgery or PPHN

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.

Eligibility criteria: 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.

Primary outcomes:
measure: iNO characteristics of administration:doses, ventilation mode,concomitant pulmonary vasodilator treatments
timeFrame: Through iNO administration, an average of 4 days
Secondary outcomes:
measure: Profile of patients: age, gender, disease characteristics.
timeFrame: 1 day
measure: Number and percentage of patients with adverse events
timeFrame: During iNO administration, an average of 4 days
measure: Number and percentage of patients with adverse drug reaction
timeFrame: From 1h after the end of iNO administration up to 28 days after ICU discharge
measure: Investigator's opinion regarding EZ-KINOX use
timeFrame: Through iNO administration, an average of 4 days
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires ST Luc
city: Liège
country: Belgium
facility: CHU Sart TILMAN
city: Paris
country: France
facility: Hôpital Pitié-Salpêtrière
state: Cedex 13
city: Paris
country: France
facility: Hôpital Necker-Enfants Malades
state: Paris cedex
city: Bordeaux
country: France
facility: Hôpital Haut-Lévèque
city: Dijon
country: France
facility: Hôpital du Bocage Central
city: Montpellier
country: France
facility: CHU Montpellier - Hôpital Arnaud de Villeneuve
city: Montpellier
country: France
facility: Hôpital Arnaud de Villeneuve
city: Nantes
country: France
facility: CHU de Nantes - Hôpital Laennec
city: Nantes
country: France
facility: Hôpital Hôtel Dieu
city: Paris
country: France
facility: Hôpital Trousseau
city: Paris
country: France
facility: Hôpital Necker-Enfants Malades
city: Reims
country: France
facility: American Memorial Hospital
city: Toulouse
country: France
facility: Clinique Pasteur
Study officials:
affiliation: Hôpital Necker-Enfants Malades
name: Philippe POUARD, MD
role: STUDY_CHAIR
References:
citation: Pepke-Zaba J, Higenbottam TW, Dinh-Xuan AT, Stone D, Wallwork J. Inhaled nitric oxide as a cause of selective pulmonary vasodilatation in pulmonary hypertension. Lancet. 1991 Nov 9;338(8776):1173-4. doi: 10.1016/0140-6736(91)92033-x.
citation: Gaudard P, Barbanti C, Rozec B, Mauriat P, M'rini M, Cambonie G, Liet JM, Girard C, Leger PL, Assaf Z, Damas P, Loron G, Lecourt L, Amour J, Pouard P. New Modalities for the Administration of Inhaled Nitric Oxide in Intensive Care Units After Cardiac Surgery or for Neonatal Indications: A Prospective Observational Study. Anesth Analg. 2018 Apr;126(4):1234-1240. doi: 10.1213/ANE.0000000000002813.