Acute Cardiogenic Pulmonary EdemaOPTICAPNCT02874339
High Flow Nasal Oxygen Versus VNI in Acute Hypercapnic Cardiogenic Pulmonary Edema
A study testing High flow nasal oxygen therapy and Non invasive ventilation in people with Acute Cardiogenic Pulmonary Edema and Hypercapnic Respiratory Failure, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The purpose of this study is to determine whether high flow nasal oxygen (HFNO) therapy is non inferior to non invasive ventilation (NIV) in the immediate treatment of patients with acute hypercapnic cardiogenic pulmonary edema associated with respiratory failure in the emergency department. 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 oxygen therapy and Non invasive ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- 26 Oct 2016to Sep 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Asuspected diagnosis of acute 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 or radiology signs:
- Use of accessory respiratory muscles
Show all 11Show fewer
- 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)
Who cannot join
- Chronic respiratory disease or associated dyspnea from non cardiac origin,
- Fever (>38,5°), sepsis or ongoing infection,
- Contra-indication to NIV,
- Treatment with NIV or CPAP prior to inclusion, including prehospital treatment
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Montpellier University Hospital
Montpellier, 34295
About this study
Official title: High Flow Nasal Oxygen Versus VNI for Emergency Department Treatment of Acute Hypercapnic Cardiogenic Pulmonary Edema With Respiratory Failure: a Multicenter Randomized Non Inferiority Trial
The purpose of this study is to determine whether high flow nasal oxygen (HFNO) therapy is non inferior to non invasive ventilation (NIV) in the immediate treatment of patients with acute hypercapnic cardiogenic pulmonary edema associated with respiratory failure in the emergency department.
Read the detailed description
Prospective multicenter study including ED patients with a suspected diagnosis of acute hypercapnic pulmonary edema with respiratory failure 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 be randomly assigned to NIV or high flow nasal oxygen therapy, with stratification on center and severity of hypercania.
Assigned Treatment will be administered during at least one session of 1hr and resumed as needed based on the patient's signs of respiratory distress and blood gas results Repeat evaluation of arterial blood gases, clinical parameters and dyspnea will be performed before and after the first and second hour of treatment according to current recommendation from the French society of anesthesia and intensive care medicine (SFAR).
- Being tested
- High flow nasal oxygen therapy, Non invasive ventilation
- 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 oxygen therapyDevice
Also called Optiflow TM
In the optiflow group, oxygen 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 ventilationDevice
In the NIV group, NIV will be delivered through a face mask connected to a ventilator with pressure support applied in a noninvasive ventilation mode. 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 Group | Experimental | High flow nasal oxygen therapy Receives: Device: High flow nasal oxygen therapy |
| NIV group | Active comparator | Not described Receives: Device: Non invasive ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with a normalized PaCO2
(PaCO2 equal or lower than 45 mmHg)
Measured: 1hr of treatment
Secondary outcomes (11)
Blood gas parameters
Blood gas parameters will be measured from standard laboratory arterial blood gas analysis
Measured: 1hr
Blood gas parameters
Blood gas parameters will be measured from standard laboratory arterial blood gas analysis
Measured: 2hr
Blood gas parameters
Blood gas parameters will be measured from standard laboratory arterial blood gas analysis
Measured: End of management (before discharge from ER)
Patient's dypnea
Dyspnea will be assessed by the emergency physician based on patient's use of accessory respiratory muscles, and measured using a 5-point likert scale.
Dyspnea score will be recorded by the patient using a Modified Borg scale for dyspnea
Measured: 1hr
Patient's dypnea
Dyspnea will be assessed by the emergency physician based on patient's use of accessory respiratory muscles, and measured using a 5-point likert scale.
Dyspnea score will be recorded by the patient using a Modified Borg scale for dyspnea
Measured: 2hr
Patient's dypnea
Dyspnea will be assessed by the emergency physician based on patient's use of accessory respiratory muscles, and measured using a 5-point likert scale.
Dyspnea score will be recorded by the patient using a Modified Borg scale for dyspnea
Measured: End of management (before discharge from ER)
Patient's comfort
Comfort score will be recorded by the patient using a visual analog scale from 0 to 10 for comfort
Measured: 1hr
Patient's comfort
Comfort score will be recorded by the patient using a visual analog scale from 0 to 10 for comfort
Measured: 2hr
Patient's comfort
Comfort score will be recorded by the patient using a visual analog scale from 0 to 10 for comfort
Measured: End of management (before discharge from ER)
Endotracheal intubation
Measured: 7 day and 1 month follow up
Mortality
Measured: 7 day and 1 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2016 (estimated)
- Study start26 Oct 2016
- Primary completionOct 2018 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
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
- NCT02874339
- Sponsor's protocol ID
- 9675
- Other IDs
- 2016-A00349-42
- Acronym
- OPTICAP
- Status last verified
- Jun 2018
- First submitted
- 28 Jul 2016
- Last updated
- 13 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Flow Nasal Oxygen Versus VNI for Emergency Department Treatment of Acute Hypercapnic Cardiogenic Pulmonary Edema With Respiratory Failure: a Multicenter Randomized Non Inferiority Trial
- ClinicalTrials.gov ID
- NCT02874339
- Acronym / sponsor ID
- OPTICAP / 9675
- Keywords
- Acute cardiogenic pulmonary, Respiratory failure, Hypercapnia, High flow nasal oxygen, Non invasive ventilation, Emergency department
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Fisher and Paykel Healthcare
- Study start
- 26 Oct 2016
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 22 Aug 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.
The purpose of this study is to determine whether high flow nasal oxygen (HFNO) therapy is non inferior to non invasive ventilation (NIV) in the immediate treatment of patients with acute hypercapnic cardiogenic pulmonary edema associated with respiratory failure in the emergency department.
Detailed description
Prospective multicenter study including ED patients with a suspected diagnosis of acute hypercapnic pulmonary edema with respiratory failure 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 be randomly assigned to NIV or high flow nasal oxygen therapy, with stratification on center and severity of hypercania.
Assigned Treatment will be administered during at least one session of 1hr and resumed as needed based on the patient's signs of respiratory distress and blood gas results Repeat evaluation of arterial blood gases, clinical parameters and dyspnea will be performed before and after the first and second hour of treatment according to current recommendation from the French society of anesthesia and intensive care medicine (SFAR).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Optiflow Group | Experimental | Device: High flow nasal oxygen therapyHigh flow nasal oxygen therapy |
| NIV group | Active comparator | Device: Non invasive ventilation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Asuspected diagnosis of acute 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 or radiology signs:
Key exclusion criteria (4 listed)
- Chronic respiratory disease or associated dyspnea from non cardiac origin,
- Fever (>38,5°), sepsis or ongoing infection,
- Contra-indication to NIV,
- Treatment with NIV or CPAP prior to inclusion, including prehospital treatment
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 oxygen therapyAlso: Optiflow TMIn the optiflow group, oxygen 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 Group |
| Non invasive ventilationIn the NIV group, NIV will be delivered through a face mask connected to a ventilator with pressure support applied in a noninvasive ventilation mode. 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 | NIV group |
Primary outcome
Proportion of patients with a normalized PaCO2
Time frame: 1hr of treatment
(PaCO2 equal or lower than 45 mmHg)
11 secondary outcomes
Blood gas parameters
Time frame: 1hr
Blood gas parameters
Time frame: 2hr
Blood gas parameters
Time frame: End of management (before discharge from ER)
Patient's dypnea
Time frame: 1hr
Patient's dypnea
Time frame: 2hr
Patient's dypnea
Time frame: End of management (before discharge from ER)
Patient's comfort
Time frame: 1hr
Patient's comfort
Time frame: 2hr
Patient's comfort
Time frame: End of management (before discharge from ER)
Endotracheal intubation
Time frame: 7 day and 1 month follow up
Mortality
Time frame: 7 day and 1 month follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2018.
- 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?
A study testing High flow nasal oxygen therapy and Non invasive ventilation in people with 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 4 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: status not confirmed, as of the sponsor's last update on 13 Jun 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mustapha Sebbane, MD, PhD (0033(4)67337974, m-sebbane@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with a normalized PaCO2 (time frame: 1hr of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jun 2018.