Cardiogenic Pulmonary EdemaNCT04971213
HIgh Flow Versus NIV for Acute Cardiogenic PuLmonary Oedema With Acute Respiratory Failure in an ED
A study testing Non invasive ventilation and High-flow nasal cannula heated and humidified oxygen in people with Cardiogenic Pulmonary Edema, run by Poitiers University Hospital at 1 site in France.
Trial summary
The purpose of this study is to compare non invasive ventilation to high flow nasal cannula oxygen for the management of patients admitted with an acute respiratory failure due to an acute cardiogenic pulmonary edema. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Cardiogenic Pulmonary Edema
- What is being tested?
- Non invasive ventilation and High-flow nasal cannula heated and humidified oxygen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 22 Sep 2021to 1 Dec 2022
- Phase
- Interventional
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age over or equal 18 years old
- admitted in an Emergency Department
- acute respiratory failure defined by a respiratory rate over or equal 25 breathes/min or signs of increased work of breathing
- clinical suspicion of acute heart failure defined bu the European Cardiologic Society.
Who cannot join
- patient requiring immediate invasive mechanical ventilation
- neurologic distress defined by a Glasgow Coma Scale under 13
- haemodynamic failure defined by a Mean Blood Pressure under 65 mmHg or patient requiring catecholamines
Trial locations and contacts
1 site in 1 country.
About this study
Official title: HIgh Flow Nasal Cannula Versus Noninvasive Ventilation for Acute Cardiogenic PuLmonary Oedema With Acute Respiratory Failure in an ED
The purpose of this study is to compare non invasive ventilation to high flow nasal cannula oxygen for the management of patients admitted with an acute respiratory failure due to an acute cardiogenic pulmonary edema.
Read the detailed description
Acute cardiogenic pulmonary oedema is a leading cause of acute respiratory distress in patients admitted in an Emergency Department. With diuretics and nitrite derivative, noninvasive ventilation is the first-line treatment of acute pulmonary oedema recommended by the European Society of Cardiology. Noninvasive ventilation is able to reduce the respiratory rate faster than standard oxygen therapy, to improve oxygenation, and some data suggest it could reduce the mortality rate. NIV may be poorly tolerated in certain patients, in whom it is associated with failure of treatment and poor outcomes. High-flow nasal cannula heated and humidified oxygen (HFNO) is a ventilatory support used in ICU and recently introduced in Emergency Departments. As compared NIV and standard oxygen therapy, HFNO reduces the mortality rate in patients with acute hypoxemic respiratory failure hospitalized in an ICU. In addition, in these patients, HFNO is also better tolerated than noninvasive ventilation. Some data suggested HFNO is superior to standard oxygen therapy in acute pulmonary oedema and could have a similar clinical effect to NIV. However, there is no research that has compared tolerance of patients admitted in an ED with acute pulmonary oedema and treated by HFNO or NIV.
Included patients will be treated with NIV or HFNO. NIV will be provided with an emergency and transport ventilator (Monnal T60, Airliquide, Antony, France) and HFNO will be provided with an AirVO2 device (Fisher and Paykel, New Zealand). Patients will be treated in an Emergency Department immediately after their admission and their consent. Treatment will be provided for a minimum of one hour. Tolerance of patients will be measured under treatment using a comfort numerical scale from 0 - well comfortable to 10 extremely uncomfortable. Clinical and biological patterns will be also recorded. Patients will be followed from their inclusion to 28 days after their inclusion.
- Conditions
- Cardiogenic Pulmonary Edema
- Being tested
- Non invasive ventilation, High-flow nasal cannula heated and humidified oxygen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non invasive ventilationDevice
Emergency and transport ventilator (Monnal T60, Airliquide, Antony, France)
High-flow nasal cannula heated and humidified oxygenDevice
AirVO2 device (Fisher and Paykel, New Zealand)
| Study group | Role | What they receive |
|---|---|---|
| Non Invasive Ventilation | Active comparator | Bilevel non-invasive ventilation. Support pressure will be set to obtain a 6-8 mL/kg of predicted body weight PEEP will be set within 5-10 cmH2O and FiO2 for a SpO2 equal or over 94% target. (92% in patients with chronic respiratory failure) All settings will be adjusted according tolerance of the patient. Receives: Device: Non invasive ventilation |
| High-flow nasal cannula heated and humidified oxygen | Experimental | Flow will be set at 60 L/min and ajusted according the tolerance of the patient.
FiO2 will be set according a SpO2 equal or over 94% target. (92% in patients with chronic respiratory failure) Receives: Device: High-flow nasal cannula heated and humidified oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory rate
Evolution of the respiratory rate within 60 minutes following the beginning of the treatment
Measured: 60 minutes
Secondary outcomes (8)
Clinical paterns
Respiratory rate in breaths/min, heart rate (beats/min), arterial blood pressure (mmHg), signs of increased work of breathing
Measured: 15, 30, 60, 90 minutes after the treatment's beginning
Arterial blood gas
PaCO2 (mmHg), PaO2 (mmHg), pH
Measured: 1 hour after the treatment beginning
Proportion of patients dying
Patient dying within 28 days
Measured: 28 days
Proportion of patients requiring invasive mechanical ventilation
Mechanical ventilation within 28 days.
Measured: 28 days
Comfort of patient according a numerical scale from 0 to 10
Comfort will be assessed using a numerical scale.
Measured: 30, 60 minutes after the treatment's beginning
Evolution of dyspnea according a Modified Borg Scale
Dyspnea score will be recorded by the patient using a Modified Borg scale for dyspnea
Measured: 15, 30, 60, 90 minutes after the treatment's beginning
ROX index
Rox Index was measured as following : (SpO2/FiO2)/RR
Measured: 15, 30, 60, 90 minutes after the treatment's beginning
Proportion of patients responding to the ventilatory support
Patients with a respiratory rate under or equal to 25 AND without signs of increased work of breathing.
Measured: 15, 30, 60, 90 minutes after the treatment's beginning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start22 Sep 2021
- Primary completion1 Nov 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiogenic Pulmonary EdemaStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin ALOS, MD, Study chair, CHU PoitiersNicolas MARJANOVIC, MD PhD, Principal investigator, CHU PoitiersJérémy Guenezan, MD, Study chair, CH Nord-VienneMaxime Jonchier, MD, Study chair, CHU de Poitiers (Site de Montmorillon)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04971213
- Sponsor's protocol ID
- HIPPOLYTE
- Status last verified
- Jan 2023
- First submitted
- 6 Jul 2021
- Last updated
- 6 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Marjanovic N, Piton M, Lamarre J, Alleyrat C, Couvreur R, Guenezan J, Mimoz O, Frat JP. High-flow nasal cannula oxygen versus noninvasive ventilation for the management of acute cardiogenic pulmonary edema: a randomized controlled pilot study. Eur J Emerg Med. 2024 Aug 1;31(4):267-275. doi: 10.1097/MEJ.0000000000001128. Epub 2024 Feb 16.
PubMed 38364020
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIgh Flow Nasal Cannula Versus Noninvasive Ventilation for Acute Cardiogenic PuLmonary Oedema With Acute Respiratory Failure in an ED
- ClinicalTrials.gov ID
- NCT04971213
- Acronym / sponsor ID
- HIPPOLYTE
- Conditions
- Cardiogenic Pulmonary Edema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 22 Sep 2021 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 21 Jul 2021 (actual)
- 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.
The purpose of this study is to compare non invasive ventilation to high flow nasal cannula oxygen for the management of patients admitted with an acute respiratory failure due to an acute cardiogenic pulmonary edema.
Detailed description
Acute cardiogenic pulmonary oedema is a leading cause of acute respiratory distress in patients admitted in an Emergency Department. With diuretics and nitrite derivative, noninvasive ventilation is the first-line treatment of acute pulmonary oedema recommended by the European Society of Cardiology. Noninvasive ventilation is able to reduce the respiratory rate faster than standard oxygen therapy, to improve oxygenation, and some data suggest it could reduce the mortality rate. NIV may be poorly tolerated in certain patients, in whom it is associated with failure of treatment and poor outcomes. High-flow nasal cannula heated and humidified oxygen (HFNO) is a ventilatory support used in ICU and recently introduced in Emergency Departments. As compared NIV and standard oxygen therapy, HFNO reduces the mortality rate in patients with acute hypoxemic respiratory failure hospitalized in an ICU. In addition, in these patients, HFNO is also better tolerated than noninvasive ventilation. Some data suggested HFNO is superior to standard oxygen therapy in acute pulmonary oedema and could have a similar clinical effect to NIV. However, there is no research that has compared tolerance of patients admitted in an ED with acute pulmonary oedema and treated by HFNO or NIV.
Included patients will be treated with NIV or HFNO. NIV will be provided with an emergency and transport ventilator (Monnal T60, Airliquide, Antony, France) and HFNO will be provided with an AirVO2 device (Fisher and Paykel, New Zealand). Patients will be treated in an Emergency Department immediately after their admission and their consent. Treatment will be provided for a minimum of one hour. Tolerance of patients will be measured under treatment using a comfort numerical scale from 0 - well comfortable to 10 extremely uncomfortable. Clinical and biological patterns will be also recorded. Patients will be followed from their inclusion to 28 days after their inclusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non Invasive Ventilation | Active comparator | Device: Non invasive ventilationBilevel non-invasive ventilation. Support pressure will be set to obtain a 6-8 mL/kg of predicted body weight PEEP will be set within 5-10 cmH2O and FiO2 for a SpO2 equal or over 94% target. (92% in patients with chronic respiratory failure) All settings will be adjusted according tolerance of the patient. |
| High-flow nasal cannula heated and humidified oxygen | Experimental | Device: High-flow nasal cannula heated and humidified oxygenFlow will be set at 60 L/min and ajusted according the tolerance of the patient. FiO2 will be set according a SpO2 equal or over 94% target. (92% in patients with chronic respiratory failure) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age over or equal 18 years old
- admitted in an Emergency Department
- acute respiratory failure defined by a respiratory rate over or equal 25 breathes/min or signs of increased work of breathing
- clinical suspicion of acute heart failure defined bu the European Cardiologic Society.
Key exclusion criteria (3 listed)
- patient requiring immediate invasive mechanical ventilation
- neurologic distress defined by a Glasgow Coma Scale under 13
- haemodynamic failure defined by a Mean Blood Pressure under 65 mmHg or patient requiring catecholamines
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 |
|---|---|---|
| Non invasive ventilationEmergency and transport ventilator (Monnal T60, Airliquide, Antony, France) | Device | Non Invasive Ventilation |
| High-flow nasal cannula heated and humidified oxygenAirVO2 device (Fisher and Paykel, New Zealand) | Device | High-flow nasal cannula heated and humidified oxygen |
Primary outcome
Respiratory rate
Time frame: 60 minutes
Evolution of the respiratory rate within 60 minutes following the beginning of the treatment
8 secondary outcomes
Clinical paterns
Time frame: 15, 30, 60, 90 minutes after the treatment's beginning
Arterial blood gas
Time frame: 1 hour after the treatment beginning
Proportion of patients dying
Time frame: 28 days
Proportion of patients requiring invasive mechanical ventilation
Time frame: 28 days
Comfort of patient according a numerical scale from 0 to 10
Time frame: 30, 60 minutes after the treatment's beginning
Evolution of dyspnea according a Modified Borg Scale
Time frame: 15, 30, 60, 90 minutes after the treatment's beginning
ROX index
Time frame: 15, 30, 60, 90 minutes after the treatment's beginning
Proportion of patients responding to the ventilatory support
Time frame: 15, 30, 60, 90 minutes after the treatment's beginning
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 6 Jan 2023.
- Derived from this study: PubMed 38364020Marjanovic N, Piton M, Lamarre J, Alleyrat C, Couvreur R, Guenezan J, Mimoz O, Frat JP. High-flow nasal cannula oxygen versus noninvasive ventilation for the management of acute cardiogenic pulmonary edema: a randomized controlled pilot study. Eur J Emerg Med. 2024 Aug 1;31(4):267-275. doi: 10.1097/MEJ.0000000000001128. Epub 2024 Feb 16.
- Individual participant dataSharing planned: No
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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.
Benjamin ALOS, MD study chair
CHU Poitiers
Nicolas MARJANOVIC, MD PhD principal investigator
CHU Poitiers
Jérémy Guenezan, MD study chair
CH Nord-Vienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non invasive ventilation and High-flow nasal cannula heated and humidified oxygen in people with Cardiogenic Pulmonary Edema, run by Poitiers University Hospital at 1 site in France.
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 4 inclusion and 3 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 6 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Respiratory rate (time frame: 60 minutes). 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 NCT04971213, which also lists 1 linked publication.
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 6 Jan 2023.