Acute Cardiogenic Pulmonary EdemaPhase 4NCT00912158
Non Invasive Mechanical Ventilation in Acute Cardiogenic Pulmonary Edema
A Phase 4 study testing standard therapy (ST), CPAP and BIPAP in people with Acute Cardiogenic Pulmonary Edema, run by Assiut University at 1 site in Egypt.
Trial summary
Cardiogenic pulmonary edema (CPE) is a common medical emergency and noninvasive ventilation (NIV) in addition to conventional medical treatment might be beneficial for patients with CPE. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Cardiogenic Pulmonary Edema
- What is being tested?
- standard therapy (ST), CPAP and BIPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2003to Nov 2007
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- CPE confirmed radiologically and/or clinically
- Severe acute respiratory failure (partial arterial oxygen (PaO2)/Fraction of inspired oxygen (FIO2) less than 250)
- Dyspnea of sudden onset with respiratory
- Systolic blood pressure < 180 mmHg
Who cannot join
- Immediate need for endotracheal intubation:
- Severe sensorial impairment
- Shock
- Ventricular arrhythmias,
- Life-threatening hypoxia (SpO2 [oxygen saturation as indicated by pulse oximetry] less than 80% with oxygen)
- Acute myocardial infarction necessitating thrombolysis
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- Cardiac or respiratory arrest
- Severe chronic renal failure
- Pneumothorax.
- Contraindication of non invasive ventilation (NIV)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CPAP Versus BiPAP in Acute Cardiogenic Pulmonary Edema: Experience With 129 Patients
Cardiogenic pulmonary edema (CPE) is a common medical emergency and noninvasive ventilation (NIV) in addition to conventional medical treatment might be beneficial for patients with CPE.
Read the detailed description
To evaluate the effect of adding continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BiPAP) to standard medical therapy (ST) on intensive care unit (ICU) stay, hospital stay, mortality, need for endotracheal intubation, partial arterial O2 tension (PaO2), intrapulmonary shunt, alveolar-arterial (A-a) oxygen gradient, and cardiac output in patients admitted to the respiratory intensive care unit (ICU) or cardiac care unit (CCU) with acute CPE with gas exchange abnormalities and to evaluate the impact of heart failure type on the outcome of different therapeutic schedules.
- Conditions
- Acute Cardiogenic Pulmonary Edema
- Being tested
- standard therapy (ST), CPAP, BIPAP
- Keywords
- CPE, CPAP, BiPAP, non invasive mechanical ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard therapy (ST)Other
Also called Medical treatment of acute cardiogenic pulmonary oedema
standard medical therapy
CPAPDevice
Also called Continuous postive air way pressure, noninvasive positive support ventilation (NPSV)
Non-invasive mechanical ventilation (CPAP)
BIPAPDevice
Also called Bilevel Positive Airway Pressure ventilation
Non-invasive mechanical ventilation (BIPAP)
| Study group | Role | What they receive |
|---|---|---|
| CPAP + ST | Active comparator | Continuous positive airway pressure (CPAP) and Standard medical therapy (ST) Receives: Device: CPAP |
| BiPAP + ST | Active comparator | Bilevel positive airway pressure (BiPAP) and standard medical therapy (ST) Receives: Device: BIPAP |
| ST | Active comparator | Standard Medical therapy (ST) Receives: Other: standard therapy (ST) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Who Were Intubated
Number of patients who were subjected to endotracheal intubation and invasive mechanical ventilation
Measured: During ICU Stay
Secondary outcomes (1)
Arterial Blood Gases, Respiratory Rate, Blood Pressure, Cardiac Output ,Intrapulmonary Shunt, A-a Oxygen Gradient, Heart Rate, and Dyspnea Duration of Hospital and ICU Stay and Mortality
Measured: Hospital stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2009 (estimated)
- Study startOct 2003
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)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 Assiut UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Investigators
- Gamal M Agmy, MD, FCCP, Principal investigator, Chest Department, Faculty of Medicine-Assiut UniversityMaha K Ghanem, MD, Study chair, Chest Department, Faculty of Medicine- Assiut UniversityHoda A Makhlouf, MD, Study chair, Chest Department, Faculty of Medicine- Assiut UniversityAmany O Mohamed, MD, Study chair, Chest Department, Faculty of Medicine- Assiut UniversityHamdy S Mohamed, MD, Study chair, Cardiology Department, Faculty of Medicine- Assiut UniversityHatem A Helmy, MD, Study chair, Cardiology Department, Faculty of Medicine - Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00912158
- Sponsor's protocol ID
- RICU, Assiut University 1
- Status last verified
- Aug 2009
- First submitted
- 8 Apr 2009
- Last updated
- 4 Sep 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Chadda K, Annane D, Hart N, Gajdos P, Raphael JC, Lofaso F. Cardiac and respiratory effects of continuous positive airway pressure and noninvasive ventilation in acute cardiac pulmonary edema. Crit Care Med. 2002 Nov;30(11):2457-61. doi: 10.1097/00003246-200211000-00009.
PubMed 12441754Gray A, Goodacre S, Newby DE, Masson M, Sampson F, Nicholl J; 3CPO Trialists. Noninvasive ventilation in acute cardiogenic pulmonary edema. N Engl J Med. 2008 Jul 10;359(2):142-51. doi: 10.1056/NEJMoa0707992.
PubMed 18614781Agarwal R, Aggarwal AN, Gupta D, Jindal SK. Non-invasive ventilation in acute cardiogenic pulmonary oedema. Postgrad Med J. 2005 Oct;81(960):637-43. doi: 10.1136/pgmj.2004.031229.
PubMed 16210459Vital FM, Saconato H, Ladeira MT, Sen A, Hawkes CA, Soares B, Burns KE, Atallah AN. Non-invasive positive pressure ventilation (CPAP or bilevel NPPV) for cardiogenic pulmonary edema. Cochrane Database Syst Rev. 2008 Jul 16;(3):CD005351. doi: 10.1002/14651858.CD005351.pub2.
PubMed 18646124
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CPAP Versus BiPAP in Acute Cardiogenic Pulmonary Edema: Experience With 129 Patients
- ClinicalTrials.gov ID
- NCT00912158
- Acronym / sponsor ID
- RICU, Assiut University 1
- Conditions
- Acute Cardiogenic Pulmonary Edema
- Keywords
- CPE, CPAP, BiPAP, non invasive mechanical ventilation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2003
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 3 Jun 2009 (estimated)
- Results
- Posted 3 Jun 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cardiogenic pulmonary edema (CPE) is a common medical emergency and noninvasive ventilation (NIV) in addition to conventional medical treatment might be beneficial for patients with CPE.
Detailed description
To evaluate the effect of adding continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BiPAP) to standard medical therapy (ST) on intensive care unit (ICU) stay, hospital stay, mortality, need for endotracheal intubation, partial arterial O2 tension (PaO2), intrapulmonary shunt, alveolar-arterial (A-a) oxygen gradient, and cardiac output in patients admitted to the respiratory intensive care unit (ICU) or cardiac care unit (CCU) with acute CPE with gas exchange abnormalities and to evaluate the impact of heart failure type on the outcome of different therapeutic schedules.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CPAP + ST | Active comparator | Device: CPAPContinuous positive airway pressure (CPAP) and Standard medical therapy (ST) |
| BiPAP + ST | Active comparator | Device: BIPAPBilevel positive airway pressure (BiPAP) and standard medical therapy (ST) |
| ST | Active comparator | Other: standard therapy (ST)Standard Medical therapy (ST) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- CPE confirmed radiologically and/or clinically
- Severe acute respiratory failure (partial arterial oxygen (PaO2)/Fraction of inspired oxygen (FIO2) less than 250)
- Dyspnea of sudden onset with respiratory
- Systolic blood pressure < 180 mmHg
Key exclusion criteria (10 listed)
- Immediate need for endotracheal intubation:
- Severe chronic renal failure
- Pneumothorax.
- Contraindication of non invasive ventilation (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 |
|---|---|---|
| standard therapy (ST)Also: Medical treatment of acute cardiogenic pulmonary oedemastandard medical therapy | Other | ST |
| CPAPAlso: Continuous postive air way pressure, noninvasive positive support ventilation (NPSV)Non-invasive mechanical ventilation (CPAP) | Device | CPAP + ST |
| BIPAPAlso: Bilevel Positive Airway Pressure ventilationNon-invasive mechanical ventilation (BIPAP) | Device | BiPAP + ST |
Primary outcome
Number of Patients Who Were Intubated
Time frame: During ICU Stay
Number of patients who were subjected to endotracheal intubation and invasive mechanical ventilation
1 secondary outcome
Arterial Blood Gases, Respiratory Rate, Blood Pressure, Cardiac Output ,Intrapulmonary Shunt, A-a Oxygen Gradient, Heart Rate, and Dyspnea Duration of Hospital and ICU Stay and Mortality
Time frame: Hospital stay
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2009.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12441754Chadda K, Annane D, Hart N, Gajdos P, Raphael JC, Lofaso F. Cardiac and respiratory effects of continuous positive airway pressure and noninvasive ventilation in acute cardiac pulmonary edema. Crit Care Med. 2002 Nov;30(11):2457-61. doi: 10.1097/00003246-200211000-00009.
- Background: PubMed 18614781Gray A, Goodacre S, Newby DE, Masson M, Sampson F, Nicholl J; 3CPO Trialists. Noninvasive ventilation in acute cardiogenic pulmonary edema. N Engl J Med. 2008 Jul 10;359(2):142-51. doi: 10.1056/NEJMoa0707992.
- Background: PubMed 16210459Agarwal R, Aggarwal AN, Gupta D, Jindal SK. Non-invasive ventilation in acute cardiogenic pulmonary oedema. Postgrad Med J. 2005 Oct;81(960):637-43. doi: 10.1136/pgmj.2004.031229.
- Results publication: PubMed 18646124Vital FM, Saconato H, Ladeira MT, Sen A, Hawkes CA, Soares B, Burns KE, Atallah AN. Non-invasive positive pressure ventilation (CPAP or bilevel NPPV) for cardiogenic pulmonary edema. Cochrane Database Syst Rev. 2008 Jul 16;(3):CD005351. doi: 10.1002/14651858.CD005351.pub2.
- Medscape: Free CME, Medical News, Full-text Journal Articles \& MoreLink provided by the sponsor.
- U.S. National Library of Medicine \& the National Institutes of HealthLink provided by the sponsor.
- The Cochrane library: Evidence for healthcare decision-makingLink provided by the sponsor.
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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.
Gamal M Agmy, MD, FCCP principal investigator
Chest Department, Faculty of Medicine-Assiut University
Maha K Ghanem, MD study chair
Chest Department, Faculty of Medicine- Assiut University
Hoda A Makhlouf, MD study chair
Chest Department, Faculty of Medicine- Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing standard therapy (ST), CPAP and BIPAP in people with Acute Cardiogenic Pulmonary Edema, run by Assiut University at 1 site in Egypt.
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 4 inclusion and 10 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 4 Sep 2009. 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 Egypt. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jun 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Patients Who Were Intubated (time frame: During ICU Stay). 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 NCT00912158, which also lists 4 linked publications.
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 4 Sep 2009.