Pulmonary EdemaPhase 4NCT00446498
CPAP Versus NPPV in ACPE
A Phase 4 study testing CPAP and Non Invasive Ventilation in people with Pulmonary Edema, run by Ospedale S. Giovanni Bosco at 1 site in Italy.
Trial summary
To assess the intubation rate in patients affected by severe cardiogenic pulmonary edema treated with CPAP or NPPV. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Edema
- What is being tested?
- CPAP and Non Invasive Ventilation
- Type of treatment
- Medical device
- How many people
- 80 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 breath per minute
- use of accessory respiratory muscles
- PaO2/FiO2 < 200, radiological findings of ACPE
Who cannot join
- ST elevation myocardial infarction
- hemodynamic instability (systolic arterial pressure < 90 mmHg
- need for immediate endotracheal intubation (respiratory arrest, bradypnea
- inability to protect the airways, impaired sensorium (agitation or unconsciousness
- inability to clear secretions, respiratory tract infections
- chronic obstructive pulmonary disease (COPD) exacerbation, chronic respiratory failure necessitating long-term oxygen therapy
Show all 10Show fewer
- pulmonary embolism, pneumonia, recent oesophageal-gastric surgery
- gastrointestinal bleeding
- facial deformities
- haematological malignancy or cancer with Eastern Cooperative Oncology Group (ECOG) performance status ≥ 2.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Continuous Positive Airway Pressure Versus Non-Invasive Positive Pressure Support Ventilation in Acute Cardiogenic Pulmonary Oedema: a Prospective Randomised Multicentre Trial.
To assess the intubation rate in patients affected by severe cardiogenic pulmonary edema treated with CPAP or NPPV.
Read the detailed description
Background Although non-invasive ventilation has shown to be an effective treatment for acute cardiogenic pulmonary oedema (ACPO), literature still lacks of multi-centre randomised prospective studies that compares CPAP with NPPV.
Aim of the study was to assess efficacy and safety of CPAP and NPPV in patients with ACPO.
Methods 80 patients with ACPO were randomly assigned to receive CPAP or NPPV (40 for each group) through a face mask.
Inclusion criteria were: severe dyspnoea, respiratory rate > 30, PaO2/FiO2 < 200, muscle fatigue.
Main end-points were endotracheal intubation, length of ventilation, hospital length of stay and mortality.
- Conditions
- Pulmonary Edema
- Being tested
- CPAP and Non Invasive Ventilation
- Medical subject headings
- Pulmonary Edema
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.
Intubation rate
Secondary outcomes (3)
time of recovery
hospital length of stay
mortality and improvement in gas exchange
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 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.
- 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
- 80 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 ASL4Giovanni Ferrari, MD, Principal investigator, Ospedale San Giovanni Bosco ASL4 Torino Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00446498
- Sponsor's protocol ID
- gbosco1
- Status last verified
- Apr 2007
- First submitted
- 12 Mar 2007
- Last updated
- 3 Apr 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Positive Airway Pressure Versus Non-Invasive Positive Pressure Support Ventilation in Acute Cardiogenic Pulmonary Oedema: a Prospective Randomised Multicentre Trial.
- ClinicalTrials.gov ID
- NCT00446498
- Acronym / sponsor ID
- gbosco1
- Conditions
- Pulmonary Edema
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants
- Lead sponsor
- Ospedale S. Giovanni BoscoUniversity, hospital or other
- Study start
- Jul 2002
- Study completion
- May 2005 (actual)
- First posted
- 13 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.
To assess the intubation rate in patients affected by severe cardiogenic pulmonary edema treated with CPAP or NPPV.
Detailed description
Background Although non-invasive ventilation has shown to be an effective treatment for acute cardiogenic pulmonary oedema (ACPO), literature still lacks of multi-centre randomised prospective studies that compares CPAP with NPPV.
Aim of the study was to assess efficacy and safety of CPAP and NPPV in patients with ACPO.
Methods 80 patients with ACPO were randomly assigned to receive CPAP or NPPV (40 for each group) through a face mask.
Inclusion criteria were: severe dyspnoea, respiratory rate > 30, PaO2/FiO2 < 200, muscle fatigue.
Main end-points were endotracheal intubation, length of ventilation, hospital length of stay and mortality.
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 (5 listed)
- rapid onset of the symptoms
- severe dyspnoea at rest
- respiratory rate > 30 breath per minute
- use of accessory respiratory muscles
- PaO2/FiO2 < 200, radiological findings of ACPE
Key exclusion criteria (10 listed)
- ST elevation myocardial infarction
- hemodynamic instability (systolic arterial pressure < 90 mmHg
- need for immediate endotracheal intubation (respiratory arrest, bradypnea
- inability to protect the airways, impaired sensorium (agitation or unconsciousness
- inability to clear secretions, respiratory tract infections
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
Intubation rate
3 secondary outcomes
time of recovery
hospital length of stay
mortality and improvement in gas exchange
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 3 Apr 2007.
Related trials for Pulmonary Edema
RecruitingPhase 4
DECONGEST-AHF: Vasodilatation or Loop Diuretics in Acute Heart Failure
Pulmonary Edema, Congestive Heart Failure
Not yet recruitingObservational study
Detecting Early Weaning-induced Pulmonary Oedema Using Lung Impedance Negative Trend During SBT
Weaning-induced Pulmonary Edema, Mechanical Ventilation Weaning
Recruiting
PEP-device for Treatment of Swimming-induced Pulmonary Edema (SIPE)
Swimming Induced Pulmonary Edema (SIPE), Pulmonary Edema
Recruiting
O2 Versus CPAP Treatment Of Patients Undergoing SIPE Therapy (OCTOPUS)
Swimming Induced Pulmonary Edema (SIPE), Pulmonary Edema
RecruitingObservational study
Cardiac Function in Swimming-Induced Pulmonary Edema (SIPE)
Swimming Induced Pulmonary Edema (SIPE), Pulmonary Edema
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
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, 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 5 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 3 Apr 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?
Intubation rate. 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 3 Apr 2007.