Study on the Use of Inhaled NO (iNO)

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02821156

Acronym

POSITIVE

Enrollment

239

Registered

2016-07-01

Start date

2014-09-30

Completion date

2015-10-31

Last updated

2016-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Hypertension

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.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Days to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
iNO characteristics of administration:doses, ventilation mode,concomitant pulmonary vasodilator treatments	Through iNO administration, an average of 4 days	Data collected by questionnaire

Secondary

Measure	Time frame	Description
Profile of patients: age, gender, disease characteristics.	1 day	Data collected by questionnaire
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	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
Investigator's opinion regarding EZ-KINOX use	Through iNO administration, an average of 4 days	Data collected by questionnaire

Countries

Belgium, France

Outcome results