Study on the Use of Inhaled NO (iNO)

Pulmonary Hypertension Clinical Trial

— POSITIVE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02821156
• Other study ID #: ALMED-13-C4-046
• Status: Completed
• Phase: N/A
• First received: May 20, 2016
• Last updated: June 29, 2016
• Start date: September 2014
• Est. completion date: October 2015

Study information

• Verified date: June 2016
• Source: Air Liquide Santé International
• Contact: n/a
• Is FDA regulated: No
• Health authority: France : Comité de Protection de Personnes île de France 3Belgium: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 239
• Est. completion date: October 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypertension, Pulmonary
• Pulmonary Hypertension

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires ST Luc	Bruxelles
Belgium	CHU Sart TILMAN	Liège
France	Hôpital Haut-Lévèque	Bordeaux
France	Hôpital du Bocage Central	Dijon
France	CHU Montpellier - Hôpital Arnaud de Villeneuve	Montpellier
France	Hôpital Arnaud de Villeneuve	Montpellier
France	CHU de Nantes - Hôpital Laennec	Nantes
France	Hôpital Hôtel Dieu	Nantes
France	Hôpital Necker-Enfants Malades	Paris
France	Hôpital Necker-Enfants Malades	Paris	Paris cedex
France	Hôpital Pitié-Salpêtrière	Paris	Cedex 13
France	Hôpital Trousseau	Paris
France	American Memorial Hospital	Reims
France	Clinique Pasteur	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
Air Liquide Santé International	EURAXI Pharma

Countries where clinical trial is conducted

Belgium,  France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	iNO characteristics of administration:doses, ventilation mode,concomitant pulmonary vasodilator treatments	Data collected by questionnaire	Through iNO administration, an average of 4 days	No
Secondary	Profile of patients: age, gender, disease characteristics.	Data collected by questionnaire	1 day	No
Secondary	Number and percentage of patients with adverse events		During iNO administration, an average of 4 days	Yes
Secondary	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	Yes
Secondary	Investigator's opinion regarding EZ-KINOX use	Data collected by questionnaire	Through iNO administration, an average of 4 days	No