Cardiogenic Pulmonary EdemaPhase 3NCT00390442
Out-of-Hospital CPAP for Severe Cardiogenic Pulmonary Edema
A Phase 3 study testing continuous positive airway pressure in people with Cardiogenic Pulmonary Edema, run by Hopital Lariboisière at 1 site in France.
Trial summary
In cardiogenic pulmonary edema, Continuous Positive Airway Pressure (CPAP) added to medical treatment improves outcome. The present study was designed to assess the benefit of CPAP as a first line treatment of cardiogenic pulmonary edema in the out-of-hospital environment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiogenic Pulmonary Edema
- What is being tested?
- continuous positive airway pressure
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 1 siteFrance
- Study dates
- Start not givento not given
- Phase
- Phase 3
- 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
- Patients with clinical symptoms of acute pulmonary edema such as orthopnea, diffuse crackles without evidence of pulmonary aspiration or infection, percutaneous oxygen saturation 90% despite supplemental oxygen therapy (15 L.min-1) provided by the first responders were included in the study.
Who cannot join
- patients with a history of chronic obstructive pulmonary disease, asthma, severe stenotic valvular disease, or if they had cardiovascular collapse or an impaired level of consciousness.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Continuous Positive Airway Pressure as a First Line Therapy in Out-of-Hospital Management of Severe Cardiogenic Pulmonary Edema
In cardiogenic pulmonary edema, Continuous Positive Airway Pressure (CPAP) added to medical treatment improves outcome. The present study was designed to assess the benefit of CPAP as a first line treatment of cardiogenic pulmonary edema in the out-of-hospital environment.
Read the detailed description
Cardiogenic pulmonary edema (CPE) is a frequent presenting process for acute out-of-hospital practice. Acute left heart failure may occur from a variety of processes that rapidly deteriorates to this generalized cardiopulmonary disorder. The classical treatment of out-of-hospital CPE includes supplemental oxygen, vasodilators, loop diuretics, and morphine. If not effective, or because of the associated respiratory depression, tracheal intubation and mechanical ventilation are often needed, which, by themselves are associated with a worse prognosis. Continuous positive airway pressure (CPAP) has been proposed as an alternative to mechanical ventilation in CPE. This technique not only improves alveolar recruitment and decreases the work of breathing 4 but also reduces left ventricular afterload, and both right and left ventricular preload. The overall effect of CPAP in the acute management of CPE is to improve cardio-respiratory function and sustained tissue oxygenation. Furthermore, the combination of CPAP with medical treatment in patients with CPE significantly reduces the need for intubation and improves the outcome.
Unfortunately, very limited data are available on the effects of CPAP in the out-of-hospital practice. Thus, we tested the potential benefit of immediate use of CPAP alone in comparison with pharmacological therapy in treatment of CPE in the acute out-of-hospital environment.
The protocol lasts 45 minutes, divided into 3 periods of 15 minutes. Patients with severe pulmonary edema are randomly assigned in 2 groups: 1/ "Early CPAP" (n=63): CPAP alone (T0-T15); CPAP + medical treatment (T15-T30); medical treatment alone (T30-T45); 2/ "Late CPAP" (n=61): medical treatment alone (T0-T15); medical treatment + CPAP (T15-T30); medical treatment alone (T30-T45). Primary endpoint : effect of early CPAP on a dyspnea clinical score and on arterial blood gases. Secondary endpoints : incidence of tracheal intubation, inotropic support, and in-hospital mortality.
- Conditions
- Cardiogenic Pulmonary Edema
- Being tested
- continuous positive airway pressure
- Keywords
- cardiogenic pulmonary edema, non invasive ventilation, CPAP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous positive airway pressureDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint : effect of early CPAP on a dyspnea clinical score and on arterial blood gases.
Secondary outcomes (4)
Secondary endpoints :
incidence of tracheal intubation,
inotropic support,
in-hospital mortality.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiogenic Pulmonary EdemaStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Hopital Lariboisière
- Sponsor type
- University, hospital or other
- Investigators
- Patrick Plaisance, MD, PhD, Professor, Principal investigator, Hopital Lariboisière
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00390442
- Sponsor's protocol ID
- AOM03073, P030428, ENR20040504
- Status last verified
- Oct 2006
- First submitted
- 17 Oct 2006
- Last updated
- 19 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Continuous Positive Airway Pressure as a First Line Therapy in Out-of-Hospital Management of Severe Cardiogenic Pulmonary Edema
- ClinicalTrials.gov ID
- NCT00390442
- Acronym / sponsor ID
- AOM03073, P030428, ENR20040504
- Conditions
- Cardiogenic Pulmonary Edema
- Keywords
- cardiogenic pulmonary edema, non invasive ventilation, CPAP
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Hopital LariboisièreUniversity, hospital or other
- First posted
- 19 Oct 2006 (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.
In cardiogenic pulmonary edema, Continuous Positive Airway Pressure (CPAP) added to medical treatment improves outcome. The present study was designed to assess the benefit of CPAP as a first line treatment of cardiogenic pulmonary edema in the out-of-hospital environment.
Detailed description
Cardiogenic pulmonary edema (CPE) is a frequent presenting process for acute out-of-hospital practice. Acute left heart failure may occur from a variety of processes that rapidly deteriorates to this generalized cardiopulmonary disorder. The classical treatment of out-of-hospital CPE includes supplemental oxygen, vasodilators, loop diuretics, and morphine. If not effective, or because of the associated respiratory depression, tracheal intubation and mechanical ventilation are often needed, which, by themselves are associated with a worse prognosis. Continuous positive airway pressure (CPAP) has been proposed as an alternative to mechanical ventilation in CPE. This technique not only improves alveolar recruitment and decreases the work of breathing 4 but also reduces left ventricular afterload, and both right and left ventricular preload. The overall effect of CPAP in the acute management of CPE is to improve cardio-respiratory function and sustained tissue oxygenation. Furthermore, the combination of CPAP with medical treatment in patients with CPE significantly reduces the need for intubation and improves the outcome.
Unfortunately, very limited data are available on the effects of CPAP in the out-of-hospital practice. Thus, we tested the potential benefit of immediate use of CPAP alone in comparison with pharmacological therapy in treatment of CPE in the acute out-of-hospital environment.
The protocol lasts 45 minutes, divided into 3 periods of 15 minutes. Patients with severe pulmonary edema are randomly assigned in 2 groups: 1/ "Early CPAP" (n=63): CPAP alone (T0-T15); CPAP + medical treatment (T15-T30); medical treatment alone (T30-T45); 2/ "Late CPAP" (n=61): medical treatment alone (T0-T15); medical treatment + CPAP (T15-T30); medical treatment alone (T30-T45). Primary endpoint : effect of early CPAP on a dyspnea clinical score and on arterial blood gases. Secondary endpoints : incidence of tracheal intubation, inotropic support, and in-hospital mortality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with clinical symptoms of acute pulmonary edema such as orthopnea, diffuse crackles without evidence of pulmonary aspiration or infection, percutaneous oxygen saturation 90% despite supplemental oxygen therapy (15 L.min-1) provided by the first responders were included in the study.
Key exclusion criteria (1 listed)
- patients with a history of chronic obstructive pulmonary disease, asthma, severe stenotic valvular disease, or if they had cardiovascular collapse or an impaired level of consciousness.
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 |
|---|---|---|
| continuous positive airway pressure | Device | – |
Primary outcome
Primary endpoint : effect of early CPAP on a dyspnea clinical score and on arterial blood gases.
4 secondary outcomes
Secondary endpoints :
incidence of tracheal intubation,
inotropic support,
in-hospital mortality.
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 19 Oct 2006.
Related trials for Cardiogenic Pulmonary Edema
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Cardiogenic Shock, Pulmonary Edema Cardiac Cause
Recruiting
COMPARE-VENT Feasibility Pilot Study
Respiration Failure, Cardio Vascular Disease
Recruiting
HF vs NIV in Acute Cardiogenic Pulmonary Edema
Pulmonary Edema Cardiac Cause
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.
Patrick Plaisance, MD, PhD, Professor principal investigator
Hopital Lariboisière
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing continuous positive airway pressure in people with Cardiogenic Pulmonary Edema, run by Hopital Lariboisière 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 1 inclusion and 1 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 19 Oct 2006. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Primary endpoint : effect of early CPAP on a dyspnea clinical score and on arterial blood gases.. 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 19 Oct 2006.