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

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ClinicalTrials.gov Identifier: NCT02821156
Recruitment Status : Completed
First Posted : July 1, 2016
Last Update Posted : July 1, 2016
Sponsor:
Collaborator:
EURAXI Pharma
Information provided by (Responsible Party):
Air Liquide Santé International

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.


Condition or disease
Pulmonary Hypertension

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
Actual Enrollment : 239 participants
Time Perspective: Prospective
Official Title: Prospective Observational Study on the Use of Inhaled NO (iNO) Administered Through an Integrated deliVEry and Monitoring Device EZ-KINOX
Study Start Date : September 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Profile of patients: age, gender, disease characteristics. [ Time Frame: 1 day ]
    Data collected by questionnaire

  2. Number and percentage of patients with adverse events [ Time Frame: During iNO administration, an average of 4 days ]
  3. Number and percentage of patients with adverse drug reaction [ Time Frame: From 1h after the end of iNO administration up to 28 days after ICU discharge ]
    As no adverse drug reaction occured during this study, no specific data on time frame can be implemented

  4. Investigator's opinion regarding EZ-KINOX use [ Time Frame: Through iNO administration, an average of 4 days ]
    Data collected by questionnaire



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with PAH associated with heart surgery or PPHN
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02821156


Locations
Belgium
Cliniques Universitaires ST Luc
Bruxelles, Belgium, 1200
CHU Sart TILMAN
Liège, Belgium
France
Hôpital Pitié-Salpêtrière
Paris, Cedex 13, France, 75651
Hôpital Necker-Enfants Malades
Paris, Paris cedex, France, 75743
Hôpital Haut-Lévèque
Bordeaux, France, 33604
Hôpital du Bocage Central
Dijon, France, 21079
CHU Montpellier - Hôpital Arnaud de Villeneuve
Montpellier, France, 34295
Hôpital Arnaud de Villeneuve
Montpellier, France, 34295
CHU de Nantes - Hôpital Laennec
Nantes, France, 44093
Hôpital Hôtel Dieu
Nantes, France, 44093
Hôpital Trousseau
Paris, France, 75012
Hôpital Necker-Enfants Malades
Paris, France, 75015
American Memorial Hospital
Reims, France, 51092
Clinique Pasteur
Toulouse, France, 31076
Sponsors and Collaborators
Air Liquide Santé International
EURAXI Pharma
Investigators
Study Chair: Philippe POUARD, MD Hôpital Necker-Enfants Malades

Publications of Results:
Responsible Party: Air Liquide Santé International
ClinicalTrials.gov Identifier: NCT02821156     History of Changes
Other Study ID Numbers: ALMED-13-C4-046
First Posted: July 1, 2016    Key Record Dates
Last Update Posted: July 1, 2016
Last Verified: June 2016

Additional relevant MeSH terms:
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents