Study on the Use of Inhaled NO (iNO) (POSITIVE)

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

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Hypertension
• Intervention / Treatment: Drug

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 Type: Observational
• Enrollment (Actual): 239

Contacts and Locations

Study Locations

• Belgium
  • Bruxelles, Belgium, 1200
    • Cliniques Universitaires St Luc
  • Liège, Belgium
    • Chu Sart Tilman
• France
  • Bordeaux, France, 33604
    • Hôpital Haut-Lévêque
  • Dijon, France, 21079
    • Hôpital du Bocage Central
  • Montpellier, France, 34295
    • Hôpital Arnaud de Villeneuve
  • Montpellier, France, 34295
    • CHU Montpellier - Hôpital Arnaud de Villeneuve
  • Nantes, France, 44093
    • Hôpital Hôtel Dieu
  • Nantes, France, 44093
    • CHU De Nantes - Hopital Laennec
  • Paris, France, 75015
    • Hôpital Necker-Enfants Malades
  • Paris, France, 75012
    • Hôpital Trousseau
  • Reims, France, 51092
    • American Memorial Hospital
  • Toulouse, France, 31076
    • Clinique Pasteur
  • Cedex 13
    • Paris, Cedex 13, France, 75651
      • Hôpital Pitié-Salpêtrière
  • Paris cedex
    • Paris, Paris cedex, France, 75743
      • Hôpital Necker-Enfants Malades

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with PAH associated with heart surgery or PPHN

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Air Liquide Santé International
• Collaborators: Euraxi Pharma
• Investigators: Study Chair: Philippe POUARD, MD, Hôpital Necker-Enfants Malades

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: May 20, 2016
• First Submitted That Met QC Criteria: June 29, 2016
• First Posted (Estimate): July 1, 2016

Study Record Updates

• Last Update Posted (Estimate): July 1, 2016
• Last Update Submitted That Met QC Criteria: June 29, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Hypertension, Pulmonary; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Protective Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Antioxidants; Free Radical Scavengers; Endothelium-Dependent Relaxing Factors; Gasotransmitters; Nitric Oxide
• Other Study ID Numbers: ALMED-13-C4-046