Acute Cardiogenic Pulmonary EdemapreopticapNCT03883555
High Flow Nasal Cannula Therapy for Early Management of Acute Hypercapnic Cardiogenic Pulmonary Edema in the Emergency Department
An observational study of Acute Cardiogenic Pulmonary Edema and Hypercapnic Respiratory Failure, run by University Hospital, Montpellier at 1 site in France.
Trial summary
High flow nasal therapy (HFNT) has not been well evaluated for treating hypercapnia The purpose of this study is to determine whether high flow nasal therapy (HFNT) can decrease hypercapnia and improve respiratory distress parameters in Emergency Department patients with acute hypercapnic respiratory failure related… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Cardiogenic Pulmonary Edema, Hypercapnic Respiratory Failure
- What is being tested?
- High flow nasal therapy (HFNT) : Optiflow™ and Non invasive ventilation (niv)
- Type of treatment
- Medical device
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2015to 30 Sep 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients admitted for acute respiratory failure secondary to acute cardiogenic lung edema with hypercapnia
Who may be able to join
- a suspected diagnosis of acute cardiogenic pulmonary edema presenting with any of the following criteria:
- dyspnea (orthopnea or a worsening of dyspnea according to NYHA criteria)
- respiratory rate >20 b/min
- bilateral crepitant rales at pulmonary auscultation
- pulmonary infiltrate on chest X-ray
- signs of respiratory failure or any of the following clinical, laboratory or radiology signs:
Show all 11Show fewer
- Use of accessory respiratory muscles or paradoxical abdominal movement
- Cardiomegaly (cardiothoracic ratio >0.5)
- Hypertensive crisis
- PaO2/FiO2 ≤ 300 mmHg breathing O2> 8L/min or PaO2 ≤ 63mmHg breathing room air
- hypercapnia (PaCO2>45 mmHg at arterial blood gas analysis)
Who cannot join
- acute exacerbation of chronic obstructive pulmonary disease or associated dyspnea from non cardiac origin
- Fever (>38,5°), sepsis or ongoing infection
- Contra-indication to NIV
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High-flow Nasal Therapy for Early Management of Hypercapnic Respiratory Failure Due to Acute Cardiogenic Pulmonary Edema in the ED: a Prospective Observational Study
High flow nasal therapy (HFNT) has not been well evaluated for treating hypercapnia The purpose of this study is to determine whether high flow nasal therapy (HFNT) can decrease hypercapnia and improve respiratory distress parameters in Emergency Department patients with acute hypercapnic respiratory failure related to cardiogenic pulmonary edema and to compare its efficacy to that of non invasive ventilation.
Read the detailed description
This is a prospective observational study conducted as a preliminary study to the randomized controlled OPTICAP trial (NCT02874339).
Prospective observational exploratory study including ED patients with a suspected diagnosis of acute hypercapnic respiratory failure related to cardiogenic pulmonary edema who require NIV according to the joint recommendations from the French society of anaesthesia and intensive care and the French society for intensive care.
Patients will receive a 1hr treatment session by either NIV or HFNT, depending on the attending ED physician expertise in using HFNT Repeat evaluation of arterial blood gases and respiratory parameters and dyspnea will be performed before and after treatment sessions according to current guidelines.
Improvement in PaCO2 and other respiratory parameters after 1hr treatment by HFNT will be analysed and compared to that of NIV.
- Being tested
- High flow nasal therapy (HFNT) : Optiflow™, Non invasive ventilation (niv)
- Keywords
- Acute cardiogenic pulmonary, Respiratory failure, Hypercapnia, High flow nasal oxygen, Non invasive ventilation, Emergency department
- Medical subject headings
- Respiratory Insufficiency, Hypercapnia, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High flow nasal therapy (HFNT) : Optiflow™Device
Also called High flow nasal cannula, High flow nasal oxygen, Optiflow™
HFNT will be administered through a heated humidifier (Airvo 2, Fisher and Paykel healthcare) and applied through large bore binasal prongs.
Initial gas flow rate will be set at of 60 l/min and adjusted to 40-50 l/min based on patient's tolerance. FiO2 will be adjusted to maintain an SpO2 ≥ 92%. Initial temperature will be set at 37° and reduced according to patient's tolerance
Non invasive ventilation (niv)Device
NIV will be delivered through a face mask connected to a dedicated ventilator with pressure support applied in a noninvasive ventilation mode (Monnal T75, Airliquide Medical Systems, Antony, France).
The Pressure-support level will be adjusted to obtain an expired tidal volume of 6-8 ml/kg of predicted body weight and a respiratory rate of 25-30 b/min. PEEP (range 5-10 cm of water) and FiO2 will be adjusted to maintain an SpO2 ≥92% and to patient's comfort.
| Study group | Role | What they receive |
|---|---|---|
| Optiflow tm | High flow nasal therapy (HFNT) Receives: Device: High flow nasal therapy (HFNT) : Optiflow™ | |
| Non invasive ventilation (NIV) | Non invasive ventilation (NIV) Receives: Device: Non invasive ventilation (niv) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PaCO2 after a 1-hour treatment session
PaCO2 will be measured from standard laboratory arterial blood gas analysis performed at the end of the first 1-hour-treatment session
Measured: 1 hour
Secondary outcomes (6)
blood gas (PaO2, pH, SaO2)
blood gas (PaO2, pH, SaO2) measured from standard laboratory arterial blood gas analysis at the end of each 1h-ventilatory support session and throughout ventilatory support
Measured: at 1 hour
Respiratory rate
Respiratory rate, measured over 1-min as part of standard clinical assessment after each 1h ventilatory support session and throughout ventilatory support
Measured: at 1 hour
signs of increased work of breathing
signs of increased work of breathing assessed based on patient's use of accessory respiratory muscles and paradoxical abdominal movement and measured using 5-point likert scales ranging from 1 to 5. Signs of increased work of berthing will be assessed at the end of each 1h ventilatory support sessions throughout ventilatory support
Measured: at 1 hour
Dyspnea
Dyspnea recorded by the patient using a Modified Borg scale ranging from 0 to 10.
Dyspnea will be measured at the end of each 1h ventilatory support sessions and throughout ventilatory support
Measured: at 1 hour
comfort
Comfort recorded by the patient using a visual analog scale from 0 to 10. Comfort will be assessed at the end of each 1h ventilatory support sessions and throughout ventilatory support
Measured: at 1 hour
Proportion of patients
Proportion of patients with a normalized PaCO2 (PaCO2 equal or lower than 45 mmHg),
Measured: at 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start1 Feb 2015
- Primary completion1 Sep 2016
- Study completion30 Sep 2016
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 Acute Cardiogenic Pulmonary EdemaStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Fisher and Paykel Healthcare
- Responsible party
- Sponsor
- Investigators
- Mustapha Sebbane, MD, PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03883555
- Sponsor's protocol ID
- RECHMPL18_0457
- Acronym
- preopticap
- Status last verified
- Mar 2019
- First submitted
- 6 Mar 2019
- Last updated
- 25 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Marjanovic N, Flacher A, Drouet L, Gouhinec AL, Said H, Vigneau JF, Chollet B, Lefebvre S, Sebbane M. High-Flow Nasal Cannula in Early Emergency Department Management of Acute Hypercapnic Respiratory Failure Due to Cardiogenic Pulmonary Edema. Respir Care. 2020 Sep;65(9):1241-1249. doi: 10.4187/respcare.07278. Epub 2020 Apr 14.
PubMed 32291308
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-flow Nasal Therapy for Early Management of Hypercapnic Respiratory Failure Due to Acute Cardiogenic Pulmonary Edema in the ED: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT03883555
- Acronym / sponsor ID
- preopticap / RECHMPL18_0457
- Keywords
- Acute cardiogenic pulmonary, Respiratory failure, Hypercapnia, High flow nasal oxygen, Non invasive ventilation, Emergency department
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Fisher and Paykel Healthcare
- Study start
- 1 Feb 2015 (actual)
- Primary completion
- 1 Sep 2016 (actual)
- Study completion
- 30 Sep 2016 (actual)
- First posted
- 21 Mar 2019 (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.
High flow nasal therapy (HFNT) has not been well evaluated for treating hypercapnia The purpose of this study is to determine whether high flow nasal therapy (HFNT) can decrease hypercapnia and improve respiratory distress parameters in Emergency Department patients with acute hypercapnic respiratory failure related to cardiogenic pulmonary edema and to compare its efficacy to that of non invasive ventilation.
Detailed description
This is a prospective observational study conducted as a preliminary study to the randomized controlled OPTICAP trial (NCT02874339).
Prospective observational exploratory study including ED patients with a suspected diagnosis of acute hypercapnic respiratory failure related to cardiogenic pulmonary edema who require NIV according to the joint recommendations from the French society of anaesthesia and intensive care and the French society for intensive care.
Patients will receive a 1hr treatment session by either NIV or HFNT, depending on the attending ED physician expertise in using HFNT Repeat evaluation of arterial blood gases and respiratory parameters and dyspnea will be performed before and after treatment sessions according to current guidelines.
Improvement in PaCO2 and other respiratory parameters after 1hr treatment by HFNT will be analysed and compared to that of NIV.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Optiflow tm | – | Device: High flow nasal therapy (HFNT) : Optiflow™High flow nasal therapy (HFNT) |
| Non invasive ventilation (NIV) | – | Device: Non invasive ventilation (niv)Non invasive ventilation (NIV) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients admitted for acute respiratory failure secondary to acute cardiogenic lung edema with hypercapnia
Key inclusion criteria (11 listed)
- a suspected diagnosis of acute cardiogenic pulmonary edema presenting with any of the following criteria:
- dyspnea (orthopnea or a worsening of dyspnea according to NYHA criteria)
- respiratory rate >20 b/min
- bilateral crepitant rales at pulmonary auscultation
- pulmonary infiltrate on chest X-ray
Key exclusion criteria (3 listed)
- acute exacerbation of chronic obstructive pulmonary disease or associated dyspnea from non cardiac origin
- Fever (>38,5°), sepsis or ongoing infection
- Contra-indication to NIV
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 |
|---|---|---|
| High flow nasal therapy (HFNT) : Optiflow™Also: High flow nasal cannula, High flow nasal oxygen, Optiflow™HFNT will be administered through a heated humidifier (Airvo 2, Fisher and Paykel healthcare) and applied through large bore binasal prongs. Initial gas flow rate will be set at of 60 l/min and adjusted to 40-50 l/min based on patient's tolerance. FiO2 will be adjusted to maintain an SpO2 ≥ 92%. Initial temperature will be set at 37° and reduced according to patient's tolerance | Device | Optiflow tm |
| Non invasive ventilation (niv)NIV will be delivered through a face mask connected to a dedicated ventilator with pressure support applied in a noninvasive ventilation mode (Monnal T75, Airliquide Medical Systems, Antony, France). The Pressure-support level will be adjusted to obtain an expired tidal volume of 6-8 ml/kg of predicted body weight and a respiratory rate of 25-30 b/min. PEEP (range 5-10 cm of water) and FiO2 will be adjusted to maintain an SpO2 ≥92% and to patient's comfort. | Device | Non invasive ventilation (NIV) |
Primary outcome
Change in PaCO2 after a 1-hour treatment session
Time frame: 1 hour
PaCO2 will be measured from standard laboratory arterial blood gas analysis performed at the end of the first 1-hour-treatment session
6 secondary outcomes
blood gas (PaO2, pH, SaO2)
Time frame: at 1 hour
Respiratory rate
Time frame: at 1 hour
signs of increased work of breathing
Time frame: at 1 hour
Dyspnea
Time frame: at 1 hour
comfort
Time frame: at 1 hour
Proportion of patients
Time frame: at 1 hour
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 25 Mar 2019.
- Derived from this study: PubMed 32291308Marjanovic N, Flacher A, Drouet L, Gouhinec AL, Said H, Vigneau JF, Chollet B, Lefebvre S, Sebbane M. High-Flow Nasal Cannula in Early Emergency Department Management of Acute Hypercapnic Respiratory Failure Due to Cardiogenic Pulmonary Edema. Respir Care. 2020 Sep;65(9):1241-1249. doi: 10.4187/respcare.07278. Epub 2020 Apr 14.
- Individual participant dataSharing planned: Undecided
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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.
Mustapha Sebbane, MD, PhD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Cardiogenic Pulmonary Edema and Hypercapnic Respiratory Failure, run by University Hospital, Montpellier 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 11 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 25 Mar 2019. 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?
Change in PaCO2 after a 1-hour treatment session (time frame: 1 hour). 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 NCT03883555, 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 25 Mar 2019.