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| Name | Class |
|---|---|
| Euraxi Pharma | INDUSTRY |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug | Inhaled Nitric Oxide with monitoring by EZ-KINOX device |
|
| Measure | Description | Time Frame |
|---|---|---|
| iNO characteristics of administration:doses, ventilation mode,concomitant pulmonary vasodilator treatments | Data collected by questionnaire | Through iNO administration, an average of 4 days |
| Measure | Description | Time Frame |
|---|---|---|
| Profile of patients: age, gender, disease characteristics. | Data collected by questionnaire | 1 day |
| Number and percentage of patients with adverse events | During iNO administration, an average of 4 days |
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Inclusion Criteria:
Exclusion Criteria:
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patients with PAH associated with heart surgery or PPHN
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| Name | Affiliation | Role |
|---|---|---|
| Philippe POUARD, MD | Hôpital Necker-Enfants Malades | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cliniques Universitaires ST Luc | Brussels | 1200 | Belgium | |||
| CHU Sart TILMAN |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 1682593 | Result | 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. | |
| 29341967 | Derived | 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. |
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| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D009569 | Nitric Oxide |
| ID | Term |
|---|---|
| D026361 | Reactive Nitrogen Species |
| D005609 | Free Radicals |
| D007287 | Inorganic Chemicals |
| D009589 | Nitrogen Oxides |
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| 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 | 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 | Through iNO administration, an average of 4 days |
| Liège |
| Belgium |
| Hôpital Pitié-Salpêtrière | Paris | Cedex 13 | 75651 | France |
| Hôpital Necker-Enfants Malades | Paris | Paris Cedex | 75743 | France |
| Hôpital Haut-Lévèque | Bordeaux | 33604 | France |
| Hôpital du Bocage Central | Dijon | 21079 | France |
| CHU Montpellier - Hôpital Arnaud de Villeneuve | Montpellier | 34295 | France |
| Hôpital Arnaud de Villeneuve | Montpellier | 34295 | France |
| CHU de Nantes - Hôpital Laennec | Nantes | 44093 | France |
| Hôpital Hôtel Dieu | Nantes | 44093 | France |
| Hôpital Trousseau | Paris | 75012 | France |
| Hôpital Necker-Enfants Malades | Paris | 75015 | France |
| American Memorial Hospital | Reims | 51092 | France |
| Clinique Pasteur | Toulouse | 31076 | France |
| D002318 |
| Cardiovascular Diseases |
| D017672 |
| Nitrogen Compounds |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D009930 | Organic Chemicals |