Pulmonary EdemaPhase 3CPAPNCT00554580
Continuous Positive Airway Pressure for Acute Pulmonary Edema
A Phase 3 study testing Continuous Positive Airway Pressure (CPAP) in people with Pulmonary Edema and Dyspnea, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The investigators hypothesise that CPAP + pharmaceutical treatment, compared to pharmaceutical treatment alone, improves the respiratory and hemodynamic status of the patients before H2 after the inclusion time and decreases the rate of death and tracheal intubation during the first 48 hours. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Edema, Dyspnea, Paroxysmal
- What is being tested?
- Continuous Positive Airway Pressure (CPAP)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2004to Jul 2008
- 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
- age > 18
- acute respiratory insufficiency with hypoxia in air
- KILLIP score from 2 to 4
- absence of known ST elevation acute coronary syndrome
- accepted inform consent.
Who cannot join
- age < 18
- immediate intubation criteria (bradypnea, coma status)
- refractory shock
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Continuous Positive Airway Pressure on Short Term Inhospital Prognosis for Acute Pulmonary Edema
The investigators hypothesise that CPAP + pharmaceutical treatment, compared to pharmaceutical treatment alone, improves the respiratory and hemodynamic status of the patients before H2 after the inclusion time and decreases the rate of death and tracheal intubation during the first 48 hours.
Read the detailed description
Patients are included at home after informed consent by the emergency medical team and transported during the following 2 hours to a cardiac intensive care unit were the treatment is purchased as well. Randomization process has been done previously with envelopes ; group A : pharmaceutical treatment alone , B pharmaceutical plus CPAP. Medical treatment includes furosemide and nitroglycerin (continuous perfusion and bolus), inotropes if needed, and all other specific treatment required (ex : anti antiarrhythmic drugs). Doses are free, adapted to the clinical response for respiratory and hemodynamic distress. CPAP is a passive high flow venturi system device alimented by a hyperbaric oxygen. FiO2 can be controlled and adapted to the pulsed oxygen saturation. PEP must be initially celled at least at 7.5 cmH2O and increased to 10 if well tolerated.
- Conditions
- Pulmonary Edema, Dyspnea, Paroxysmal, Congestive Heart Failure
- Being tested
- Continuous Positive Airway Pressure (CPAP), usual care of acute pulmonary oedema
- Keywords
- continuous positive airway pressure, outcome measure, clinical trial
- Medical subject headings
- Pulmonary Edema, Dyspnea, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Positive Airway Pressure (CPAP)Procedure or surgery
Usual treatment of acute pulmonary oedema (see arm A) + CPAP will be administered without interruption for at least one hour and will be stopped for efficacy:
stade I or II KILLIP classification and FR less or equal to 25 /min and SpO2 larger than 90 % ambient air and patient willing the stop of CPAP because of improvement of his clinical status.
usual care of acute pulmonary oedemaProcedure or surgery
Usual treatment of acute pulmonary oedema including :
Oxygen, diuretic minimum one bolus IV of 40 mg FUROSEMIDE (LASILIX) possibility to repeat the dose every 15 minutes with a maximum 120 mg.
Bolus of ISOSORBIDE DINITRATE (RISORDAN) of 1 mg maybe repeated every 3 minutes.
As soon as possible perfusion of ISDN with flow adapted to the clinical status If necessary administration of DOBUTAMINE continuous perfusion of to 5 to 20 µg/kg/min.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Usual care of pulmonary acute oedema Receives: Procedure: usual care of acute pulmonary oedema |
| B | Experimental | CPAP + usual care of pulmonary acute oedema Receives: Procedure: Continuous Positive Airway Pressure (CPAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite criteria includes during the first 48 hours : death, tracheal intubation and mechanical ventilation rates, persistence of inclusion criteria for respiratory distress and shock until H2, reappearance of inclusion criteria after H2.
Measured: 48 hours
Secondary outcomes (1)
brain natriuretic factor value curves from H0, H6 and H24; composite criteria without intubation rate; clinical and biological parameters evolution during the first 48 hours, myocardial infarction rate, CPAP non tol
Measured: H0, H6, H24, H48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2007 (estimated)
- Study startOct 2004
- Primary completionJul 2008
- Study completionJul 2008
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 Pulmonary EdemaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Investigators
- DUCROS Laurent, MD PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00554580
- Sponsor's protocol ID
- P 030428
- Other IDs
- AOM 03073
- Acronym
- CPAP
- Status last verified
- Mar 2010
- First submitted
- 6 Nov 2007
- Last updated
- 30 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ducros L, Logeart D, Vicaut E, Henry P, Plaisance P, Collet JP, Broche C, Gueye P, Vergne M, Goetgheber D, Pennec PY, Belpomme V, Tartiere JM, Lagarde S, Placente M, Fievet ML, Montalescot G, Payen D; CPAP collaborative study group. CPAP for acute cardiogenic pulmonary oedema from out-of-hospital to cardiac intensive care unit: a randomised multicentre study. Intensive Care Med. 2011 Sep;37(9):1501-9. doi: 10.1007/s00134-011-2311-4. Epub 2011 Jul 30.
PubMed 21805159
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Continuous Positive Airway Pressure on Short Term Inhospital Prognosis for Acute Pulmonary Edema
- ClinicalTrials.gov ID
- NCT00554580
- Acronym / sponsor ID
- CPAP / P 030428
- Conditions
- Pulmonary Edema, Dyspnea, Paroxysmal, Congestive Heart Failure
- Keywords
- continuous positive airway pressure, outcome measure, clinical trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Oct 2004
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 7 Nov 2007 (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 investigators hypothesise that CPAP + pharmaceutical treatment, compared to pharmaceutical treatment alone, improves the respiratory and hemodynamic status of the patients before H2 after the inclusion time and decreases the rate of death and tracheal intubation during the first 48 hours.
Detailed description
Patients are included at home after informed consent by the emergency medical team and transported during the following 2 hours to a cardiac intensive care unit were the treatment is purchased as well. Randomization process has been done previously with envelopes ; group A : pharmaceutical treatment alone , B pharmaceutical plus CPAP. Medical treatment includes furosemide and nitroglycerin (continuous perfusion and bolus), inotropes if needed, and all other specific treatment required (ex : anti antiarrhythmic drugs). Doses are free, adapted to the clinical response for respiratory and hemodynamic distress. CPAP is a passive high flow venturi system device alimented by a hyperbaric oxygen. FiO2 can be controlled and adapted to the pulsed oxygen saturation. PEP must be initially celled at least at 7.5 cmH2O and increased to 10 if well tolerated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Procedure: usual care of acute pulmonary oedemaUsual care of pulmonary acute oedema |
| B | Experimental | Procedure: Continuous Positive Airway Pressure (CPAP)CPAP + usual care of pulmonary acute oedema |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age > 18
- acute respiratory insufficiency with hypoxia in air
- KILLIP score from 2 to 4
- absence of known ST elevation acute coronary syndrome
- accepted inform consent.
Key exclusion criteria (3 listed)
- age < 18
- immediate intubation criteria (bradypnea, coma status)
- refractory shock
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 (CPAP)Usual treatment of acute pulmonary oedema (see arm A) + CPAP will be administered without interruption for at least one hour and will be stopped for efficacy: stade I or II KILLIP classification and FR less or equal to 25 /min and SpO2 larger than 90 % ambient air and patient willing the stop of CPAP because of improvement of his clinical status. | Procedure or surgery | B |
| usual care of acute pulmonary oedemaUsual treatment of acute pulmonary oedema including : Oxygen, diuretic minimum one bolus IV of 40 mg FUROSEMIDE (LASILIX) possibility to repeat the dose every 15 minutes with a maximum 120 mg. Bolus of ISOSORBIDE DINITRATE (RISORDAN) of 1 mg maybe repeated every 3 minutes. As soon as possible perfusion of ISDN with flow adapted to the clinical status If necessary administration of DOBUTAMINE continuous perfusion of to 5 to 20 µg/kg/min. | Procedure or surgery | A |
Primary outcome
Composite criteria includes during the first 48 hours : death, tracheal intubation and mechanical ventilation rates, persistence of inclusion criteria for respiratory distress and shock until H2, reappearance of inclusion criteria after H2.
Time frame: 48 hours
1 secondary outcome
brain natriuretic factor value curves from H0, H6 and H24; composite criteria without intubation rate; clinical and biological parameters evolution during the first 48 hours, myocardial infarction rate, CPAP non tol
Time frame: H0, H6, H24, H48
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 30 Mar 2010.
- Derived from this study: PubMed 21805159Ducros L, Logeart D, Vicaut E, Henry P, Plaisance P, Collet JP, Broche C, Gueye P, Vergne M, Goetgheber D, Pennec PY, Belpomme V, Tartiere JM, Lagarde S, Placente M, Fievet ML, Montalescot G, Payen D; CPAP collaborative study group. CPAP for acute cardiogenic pulmonary oedema from out-of-hospital to cardiac intensive care unit: a randomised multicentre study. Intensive Care Med. 2011 Sep;37(9):1501-9. doi: 10.1007/s00134-011-2311-4. Epub 2011 Jul 30.
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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.
DUCROS Laurent, MD PhD principal investigator
Assistance Publique - Hôpitaux de Paris
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 (CPAP) in people with Pulmonary Edema and Dyspnea, run by Assistance Publique - Hôpitaux de Paris 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 5 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 30 Mar 2010. 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?
Composite criteria includes during the first 48 hours : death, tracheal intubation and mechanical ventilation rates, persistence of inclusion criteria for respiratory distress and shock until H2, reappearance of inclusion criteria after H2. (time frame: 48 hours). 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 NCT00554580, 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 30 Mar 2010.