Pulmonary HypertensionPOSITIVENCT02821156
Study on the Use of Inhaled NO (iNO)
An observational study of Pulmonary Hypertension, run by Air Liquide Santé International at 14 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Ages 1 day and older
- Conditions the study is for
- Pulmonary Hypertension
- How many people
- 239 participants
- Where
- 14 sitesin 2 countries
- Study dates
- Sep 2014to Oct 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with PAH associated with heart surgery or PPHN
Who may be able to join
- 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™
Who cannot join
- Newborn dependent on a right-to-left shunt or with a "malignant" left-right arterial canal
- Newborn with Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency.
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
France12 sites
Hôpital Haut-Lévèque
Bordeaux, 33604
Hôpital du Bocage Central
Dijon, 21079
CHU Montpellier - Hôpital Arnaud de Villeneuve
Montpellier, 34295
Hôpital Arnaud de Villeneuve
Montpellier, 34295
CHU de Nantes - Hôpital Laennec
Nantes, 44093
Hôpital Hôtel Dieu
Nantes, 44093
Hôpital Pitié-Salpêtrière
Paris, Cedex 13, 75651
Hôpital Necker-Enfants Malades
Paris, Paris Cedex, 75743
Hôpital Trousseau
Paris, 75012
Hôpital Necker-Enfants Malades
Paris, 75015
American Memorial Hospital
Reims, 51092
Clinique Pasteur
Toulouse, 31076
Belgium2 sites
Cliniques Universitaires ST Luc
Brussels, 1200
CHU Sart TILMAN
Liège
About this study
Official title: 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.
Read the 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.
- Conditions
- Pulmonary Hypertension
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug
Also called Nitric Oxide
Inhaled Nitric Oxide with monitoring by EZ-KINOX device
What is being measured
The primary outcome is the main question the study is designed to answer.
iNO characteristics of administration:doses, ventilation mode,concomitant pulmonary vasodilator treatments
Data collected by questionnaire
Measured: Through iNO administration, an average of 4 days
Secondary outcomes (4)
Profile of patients: age, gender, disease characteristics.
Data collected by questionnaire
Measured: 1 day
Number and percentage of patients with adverse events
Measured: 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
Measured: 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
Measured: Through iNO administration, an average of 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2016 (estimated)
- Study startSep 2014
- Primary completionSep 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- Air Liquide Santé International
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Euraxi Pharma
- Responsible party
- Sponsor
- Investigators
- Philippe POUARD, MD, Study chair, Hôpital Necker-Enfants Malades
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02821156
- Sponsor's protocol ID
- ALMED-13-C4-046
- Acronym
- POSITIVE
- Status last verified
- Jun 2016
- First submitted
- 20 May 2016
- Last updated
- 1 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 1682593Gaudard 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.
PubMed 29341967
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study on the Use of Inhaled NO (iNO) Administered Through an Integrated deliVEry and Monitoring Device EZ-KINOX
- ClinicalTrials.gov ID
- NCT02821156
- Acronym / sponsor ID
- POSITIVE / ALMED-13-C4-046
- Conditions
- Pulmonary Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- Air Liquide Santé InternationalIndustry (pharma, biotech, devices)
- Collaborators
- Euraxi Pharma
- Study start
- Sep 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 1 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with PAH associated with heart surgery or PPHN
Key inclusion criteria (1 listed)
- 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™
Key exclusion criteria (2 listed)
- Newborn dependent on a right-to-left shunt or with a "malignant" left-right arterial canal
- Newborn with Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Also: Nitric OxideInhaled Nitric Oxide with monitoring by EZ-KINOX device | Drug | – |
Primary outcome
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
4 secondary outcomes
Profile of patients: age, gender, disease characteristics.
Time frame: 1 day
Number and percentage of patients with adverse events
Time frame: During iNO administration, an average of 4 days
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
Investigator's opinion regarding EZ-KINOX use
Time frame: Through iNO administration, an average of 4 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2016.
- Results publication: PubMed 1682593Pepke-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.
- Derived from this study: PubMed 29341967Gaudard 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe POUARD, MD study chair
Hôpital Necker-Enfants Malades
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Hypertension, run by Air Liquide Santé International at 14 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in France, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
iNO characteristics of administration:doses, ventilation mode,concomitant pulmonary vasodilator treatments (time frame: Through iNO administration, an average of 4 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02821156, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2016.