High Flow Nasal Oxygen Versus VNI in Acute Hypercapnic Cardiogenic Pulmonary Edema (NCT02874339) | Clinical Trial Compass
UnknownNot Applicable
High Flow Nasal Oxygen Versus VNI in Acute Hypercapnic Cardiogenic Pulmonary Edema
France250 participantsStarted 2016-10-26
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria:
* 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
* 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)
Exclusion criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.