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OpenTrials
Completed

NCT Number: NCT02821156

Study on the Use of Inhaled NO (iNO)

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.

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Key information

Conditions

Pulmonary Hypertension Cardiovascular Diseases Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

1 day and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cliniques Universitaires ST Luc, Brussels, Belgium

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About this study

This study is intended to describe daily practice and therefore, there is not a standardized protocol but only patient-based and site-based questionnaires.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Air Liquide Santé International

Industry

Collaborators

  • Euraxi Pharma

Registry information

Official study title

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

Acronym: POSITIVE

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 1, 2016
Registry last updated
Jul 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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