Pulmonary EdemaPhase 4NCT00453947
Non-Invasive Ventilation in Pulmonary Edema
A Phase 4 study testing CPAP and Non Invasive Ventilation in people with Pulmonary Edema and Myocardial Infarction, run by Ospedale S. Giovanni Bosco at 1 site in Italy.
Trial summary
This randomized controlled trial is primarily aimed at assessing the rate of acute myocardial infarction with the two noninvasive ventilatory techniques, non-invasive intermittent positive pressure ventilation and non-invasive continuous positive airway pressure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Edema, Myocardial Infarction
- What is being tested?
- CPAP and Non Invasive Ventilation
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2002to May 2005
- Phase
- Phase 4
- 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
- rapid onset of the symptoms
- severe dyspnoea at rest
- respiratory rate > 30 breaths per minute
- use of accessory respiratory muscles
- oxygen saturation (SpO2) inferior to 90% with an inspiratory oxygen fraction of 60% via a Venturi mask
- radiological findings of ACPE
Who cannot join
- acute ischemic heart disease (myocardial infarction, chest pain, ST elevation)
- hemodynamic instability (i.e. systolic blood pressure < 90 with dopamine or dobutamine infusion ≥ 5 mcgr/Kg/min) or life-threatening arrhythmias
- need for immediate endotracheal intubation (respiratory arrest, bradypnea or gasping)
- inability to protect the airways
- impaired sensorium (i.e. unconsciousness or agitation)
- inability to clear secretions
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- respiratory tract infection
- recent oesophageal/gastric surgery
- gastrointestinal bleeding
- facial deformities
- hematological malignancy or cancer with an Eastern Cooperative Oncology Group performance status ≥ 2
- chronic respiratory failure necessitating long-term oxygen therapy
- diagnosis of myocardial infarction, pulmonary embolism, pneumonia, exacerbation of chronic obstructive pulmonary disease, pneumothorax in the previous 3 months
- denial or refusal of intubation
- claustrophobia
Trial locations and contacts
1 site in 1 country.
Italy1 site
Ospedale San Giovanni Bosco Medicina d'Urgenza
Torino, Torino, 10154
About this study
Official title: Non Invasive Positive Airway Pressure And Risk Of Myocardial Infarction In Acute Cardiogenic Pulmonary Edema: Continuous Positive Airway Pressure Vs Non Invasive Positive Pressure Ventilation
This randomized controlled trial is primarily aimed at assessing the rate of acute myocardial infarction with the two noninvasive ventilatory techniques, non-invasive intermittent positive pressure ventilation and non-invasive continuous positive airway pressure.
Read the detailed description
Objective: To determine whether the application of non-invasive intermittent positive pressure ventilation (n-IPPV) increases the incidence of acute myocardial infarction (AMI) in patients with acute respiratory failure (ARF) secondary to acute cardiogenic pulmonary edema (ACPE), as opposed to non-invasive continuous positive airway pressure (n-CPAP).
Background Both n-CPAP or n-IPPV are used to treat ACPE complicated by ARF. Two previous studies, however, report an increased rate of AMI associated with the use of n-IPPV.
Methods: Fifty-two patients with severe ARF consequent to ACPE were randomized to receive n-CPAP (n=27) or n-IPPV (n=25), both associated with standard medical therapy. Cardiac markers, electrocardiogram and clinical-physiological parameters were monitored at study entry, after 30 and 60 minutes, and every 6 hours for the first two days.
- Conditions
- Pulmonary Edema, Myocardial Infarction
- Being tested
- CPAP and Non Invasive Ventilation
- Medical subject headings
- Pulmonary Edema, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAP and Non Invasive VentilationDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of Acute Myocardial Infarction
Secondary outcomes (4)
Rate of endotracheal intubation
Mortality
Time of recovery (i.e. duration of ventilatory assistance)
High Dependency Unit and hospital length of stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2007 (estimated)
- Study startJul 2002
- Study completionMay 2005
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.
- 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
- 60 participants
Sponsor and investigators
- Lead sponsor
- Ospedale S. Giovanni Bosco
- Sponsor type
- University, hospital or other
- Investigators
- Giovanni Ferrari, MD, Principal investigator, Ospedale San Giovanni Bosco ASL4 Torino Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00453947
- Sponsor's protocol ID
- gbosco2
- Status last verified
- Mar 2007
- First submitted
- 28 Mar 2007
- Last updated
- 29 Mar 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ferrari G, Olliveri F, De Filippi G, Milan A, Apra F, Boccuzzi A, Converso M, Navalesi P. Noninvasive positive airway pressure and risk of myocardial infarction in acute cardiogenic pulmonary edema: continuous positive airway pressure vs noninvasive positive pressure ventilation. Chest. 2007 Dec;132(6):1804-9. doi: 10.1378/chest.07-1058. Epub 2007 Oct 1.
PubMed 17908705
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non Invasive Positive Airway Pressure And Risk Of Myocardial Infarction In Acute Cardiogenic Pulmonary Edema: Continuous Positive Airway Pressure Vs Non Invasive Positive Pressure Ventilation
- ClinicalTrials.gov ID
- NCT00453947
- Acronym / sponsor ID
- gbosco2
- Conditions
- Pulmonary Edema, Myocardial Infarction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- Ospedale S. Giovanni BoscoUniversity, hospital or other
- Study start
- Jul 2002
- Study completion
- May 2005 (actual)
- First posted
- 29 Mar 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.
This randomized controlled trial is primarily aimed at assessing the rate of acute myocardial infarction with the two noninvasive ventilatory techniques, non-invasive intermittent positive pressure ventilation and non-invasive continuous positive airway pressure.
Detailed description
Objective: To determine whether the application of non-invasive intermittent positive pressure ventilation (n-IPPV) increases the incidence of acute myocardial infarction (AMI) in patients with acute respiratory failure (ARF) secondary to acute cardiogenic pulmonary edema (ACPE), as opposed to non-invasive continuous positive airway pressure (n-CPAP).
Background Both n-CPAP or n-IPPV are used to treat ACPE complicated by ARF. Two previous studies, however, report an increased rate of AMI associated with the use of n-IPPV.
Methods: Fifty-two patients with severe ARF consequent to ACPE were randomized to receive n-CPAP (n=27) or n-IPPV (n=25), both associated with standard medical therapy. Cardiac markers, electrocardiogram and clinical-physiological parameters were monitored at study entry, after 30 and 60 minutes, and every 6 hours for the first two days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 (6 listed)
- rapid onset of the symptoms
- severe dyspnoea at rest
- respiratory rate > 30 breaths per minute
- use of accessory respiratory muscles
- oxygen saturation (SpO2) inferior to 90% with an inspiratory oxygen fraction of 60% via a Venturi mask
Key exclusion criteria (15 listed)
- acute ischemic heart disease (myocardial infarction, chest pain, ST elevation)
- hemodynamic instability (i.e. systolic blood pressure < 90 with dopamine or dobutamine infusion ≥ 5 mcgr/Kg/min) or life-threatening arrhythmias
- need for immediate endotracheal intubation (respiratory arrest, bradypnea or gasping)
- inability to protect the airways
- impaired sensorium (i.e. unconsciousness or agitation)
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 |
|---|---|---|
| CPAP and Non Invasive Ventilation | Device | – |
Primary outcome
The rate of Acute Myocardial Infarction
4 secondary outcomes
Rate of endotracheal intubation
Mortality
Time of recovery (i.e. duration of ventilatory assistance)
High Dependency Unit and hospital length of stay
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 29 Mar 2007.
- Derived from this study: PubMed 17908705Ferrari G, Olliveri F, De Filippi G, Milan A, Apra F, Boccuzzi A, Converso M, Navalesi P. Noninvasive positive airway pressure and risk of myocardial infarction in acute cardiogenic pulmonary edema: continuous positive airway pressure vs noninvasive positive pressure ventilation. Chest. 2007 Dec;132(6):1804-9. doi: 10.1378/chest.07-1058. Epub 2007 Oct 1.
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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.
Giovanni Ferrari, MD principal investigator
Ospedale San Giovanni Bosco ASL4 Torino Italy
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 CPAP and Non Invasive Ventilation in people with Pulmonary Edema and Myocardial Infarction, run by Ospedale S. Giovanni Bosco at 1 site in Italy.
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 6 inclusion and 15 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 29 Mar 2007. 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 Italy. 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?
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?
The rate of Acute Myocardial Infarction. 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 NCT00453947, 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 29 Mar 2007.