Cardiogenic Pulmonary EdemaPhase 3NCT00785174
Non-Invasive Ventilation Versus Continuous Positive Airway Pressure in Cardiogenic Pulmonary Edema: a Multicentre Study
A Phase 3 study testing continuous positive airway pressure and noninvasive pressure support ventilation in people with Cardiogenic Pulmonary Edema, run by University of Monastir.
Trial summary
Non-invasive ventilation (NIV) has become now a widely used treatment modality in ICU and emergency services to deal with respiratory failure.1 NIV has the potential to improve ventilatory assistance while avoiding endotracheal intubation and its complications. 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 and noninvasive pressure support ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Jan 2005to 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
- All patients aged >18 years and having acute respiratory failure caused by CPE.
- The origin of cardiogenic pulmonary edema is defined according to the history and clinical presentation, the chest X-ray and / or data of echocardiography when they are available with a serum BNP> 100pg/ml.
- The acute respiratory failure is defined by the existence of clinical signs and / or arterial gas parameters:
- sweats and / or agitation and / or signs of struggle and /or drowsiness
- dyspnea with respiratory rate > 35/min,
- a blood oxygen saturation ≤ 90% by air.
Who cannot join
- Instability of the hemodynamic state (severe rhythm disturbances, hypotension with systolic arterial pressure <50 mmHg, need for inotropic drugs).
- The need for immediate endotracheal intubation.
- Contraindications to the use of a facial or nasal mask (or facial skin lesion).
- History of recent gastrointestinal surgery or pseudo obstruction.
- Refusal of participation or non-cooperation of the patient.
About this study
Non-invasive ventilation (NIV) has become now a widely used treatment modality in ICU and emergency services to deal with respiratory failure.1 NIV has the potential to improve ventilatory assistance while avoiding endotracheal intubation and its complications.
Since the first publications of Meduri2 and Brochard3 the number of studies on the NIV has been growing and developing and this technique becomes one of the major progress in the field of respiratory assistance. Decompensation of chronic obstructive pulmonary disease (COPD) is certainly the least questionable indication of the NIV. However, indication of the NIV is inexorably spreading to other types of acute respiratory insufficiency, including acute cardiogenic pulmonary edema (CPE).4 Continuous positive airway pressure (CPAP) is the most currently used non-invasive ventilation usually performed without the use of a ventilator. NIV using pressure support (NIPSV) combined pressure support (inspiratory aid) and positive expiratory pressure as in CPAP. Based on physiological ground, NIPSV would be more performant than CPAP to improve ventilatory parameters and reduce the work breathing in APE. However, this issue is not settled yet. Number of meta-analysis over the last 2 years were devoted to the comparison of CPAP and NISPV,5 so that the scientific evidence is still far from established. In addition, it is not sur that patients enrolled in these studies are representative of all patients with APE. The fact that they were included solely on the basis of clinical criteria, the risk of overlap with other diagnoses is not negligible. Thus the use of markers of heart failure as the BNP (brain natriuretic peptide) would be very useful. On the other hand, the possible deleterious effect of NIPSV on myocardial perfusion is a problem that has not been definitively resolved.
Read more
Objectives of the study:
- Compare the efficacy and safety of the NIPSV with those of CPAP in patients presenting to the emergency department with CPE.
- Compare the two procedures in subgroups of patients with hypercapnia and high BNP concentration.
Read the detailed description
Cardiogenic pulmonary edema is defined as an increase of hydrostatic pressure in the pulmonary microcirculation resulting from postcapillaire hypertension.
The direct consequence is extravasation of fluid in the alveolar and interstitial tissue, leading to acute hypoxemia and a decrease in lung compliance. The decrease in lung compliance, increased airway resistance (interstitial and bronchial edema) and hypoxemia will cause an increase in work of breathing. The imbalance between the ability of respiratory muscles to generate effective gas exchange and exaggerated ventilatory load can lead to respiratory muscle fatigue requiring use of mechanical ventilation through endotracheal prosthesis. In addition, the increase in inspiratory muscles work during the CPE generates very important pleural depression, which increases transmural pressure and left ventricular afterload and thus increases pulmonary edema.
The CPAP is a non-invasive ventilation mode most currently used CPE. It is usually obtained via a mask and an expiratory valve to maintain constant pressure in the circuit. No inspiratory assistance is provided to the patient. The BOUSSIGNAC valve is currently used in clinical practice as an adjunct to the pharmacological treatment of CPE.The effect of CPAP is mainly linked to its ability to recruit zones that are collapsed during expiration. • NIPSV combines a positive expiratory pressure to ventilatory assistance pressure during inspiration delivered by a ventilator. It corresponds to a CPAP associated with inspiratory assistance, and thus, it is likely to improve the ventilation parameters, and in particular to reduce respiratory work more efficiently than CPAP alone.These beneficial physiological effects of NIPSV were well demonstrated during the decompensation of COPD ; they wait to be confirmed during CPE. Physiological studies have shown that the NIPSV is more effective in terms of reducing the work of breathing in CPE. However, none of the 7 published randomized studies has shown superiority of the NIPSV compared to CPAP in terms of reducing mortality and intubation requirement
- Conditions
- Cardiogenic Pulmonary Edema
- Being tested
- continuous positive airway pressure, noninvasive pressure support ventilation
- Keywords
- noninvasive ventilation, continuous posi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous positive airway pressureDevice
Also called Boussignac CPAP
respiratory assistance using face mask and positive expiratory pressure apllied by a Boussignac valve
noninvasive pressure support ventilationDevice
Also called NIPSV
noninvasive pressure support ventilation can provide inspiratory pressure support and expiratory positive pressure
noninvasive pressure support ventilationDevice
Also called NIPSV
noninvasive pressure support ventilation provides an inspiratory aid and positive expiratory pressure using ventilator through face mask
| Study group | Role | What they receive |
|---|---|---|
| continuous positive airway pressure | Active comparator | respiratory assistance Receives: Device: continuous positive airway pressure |
| NIPSV | Active comparator | respiratory assistance using face mak and ventilator to provide inspiratory pressure support and positive end expiratory pressure Receives: Device: noninvasive pressure support ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
It is the combination of 3 events: the need for endotracheal intubation, hospital death, and ICU hospitalisation.
Measured: 6 hours and 30 days after protocol start
Primary outcome It is the combination of 3 events: the need for endotracheal intubation, hospital death, and ICU hospitalisation.
Measured: 6 hours and 30 days after protocol start
Secondary outcomes (2)
The change in the rate of troponin
Measured: 6 hours after protocol start
The length of hospital stay
Measured: 30 days after protocol start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2008 (estimated)
- Study startJan 2005
- Primary completionJun 2008
- Study completionJul 2008
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Monastir
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00785174
- Sponsor's protocol ID
- NIV-CPAP-CPE
- Status last verified
- Nov 2008
- First submitted
- 4 Nov 2008
- Last updated
- 5 Nov 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Ventilation Versus Continuous Positive Airway Pressure in Cardiogenic Pulmonary Edema: a Multicentre Study
- ClinicalTrials.gov ID
- NCT00785174
- Acronym / sponsor ID
- NIV-CPAP-CPE
- Conditions
- Cardiogenic Pulmonary Edema
- Keywords
- noninvasive ventilation, continuous posi
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 5 Nov 2008 (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.
Non-invasive ventilation (NIV) has become now a widely used treatment modality in ICU and emergency services to deal with respiratory failure.1 NIV has the potential to improve ventilatory assistance while avoiding endotracheal intubation and its complications.
Since the first publications of Meduri2 and Brochard3 the number of studies on the NIV has been growing and developing and this technique becomes one of the major progress in the field of respiratory assistance. Decompensation of chronic obstructive pulmonary disease (COPD) is certainly the least questionable indication of the NIV. However, indication of the NIV is inexorably spreading to other types of acute respiratory insufficiency, including acute cardiogenic pulmonary edema (CPE).4 Continuous positive airway pressure (CPAP) is the most currently used non-invasive ventilation usually performed without the use of a ventilator. NIV using pressure support (NIPSV) combined pressure support (inspiratory aid) and positive expiratory pressure as in CPAP. Based on physiological ground, NIPSV would be more performant than CPAP to improve ventilatory parameters and reduce the work breathing in APE. However, this issue is not settled yet. Number of meta-analysis over the last 2 years were devoted to the comparison of CPAP and NISPV,5 so that the scientific evidence is still far from established. In addition, it is not sur that patients enrolled in these studies are representative of all patients with APE. The fact that they were included solely on the basis of clinical criteria, the risk of overlap with other diagnoses is not negligible. Thus the use of markers of heart failure as the BNP (brain natriuretic peptide) would be very useful. On the other hand, the possible deleterious effect of NIPSV on myocardial perfusion is a problem that has not been definitively resolved.
Objectives of the study:
- Compare the efficacy and safety of the NIPSV with those of CPAP in patients presenting to the emergency department with CPE.
- Compare the two procedures in subgroups of patients with hypercapnia and high BNP concentration.
Detailed description
Cardiogenic pulmonary edema is defined as an increase of hydrostatic pressure in the pulmonary microcirculation resulting from postcapillaire hypertension.
The direct consequence is extravasation of fluid in the alveolar and interstitial tissue, leading to acute hypoxemia and a decrease in lung compliance. The decrease in lung compliance, increased airway resistance (interstitial and bronchial edema) and hypoxemia will cause an increase in work of breathing. The imbalance between the ability of respiratory muscles to generate effective gas exchange and exaggerated ventilatory load can lead to respiratory muscle fatigue requiring use of mechanical ventilation through endotracheal prosthesis. In addition, the increase in inspiratory muscles work during the CPE generates very important pleural depression, which increases transmural pressure and left ventricular afterload and thus increases pulmonary edema.
The CPAP is a non-invasive ventilation mode most currently used CPE. It is usually obtained via a mask and an expiratory valve to maintain constant pressure in the circuit. No inspiratory assistance is provided to the patient. The BOUSSIGNAC valve is currently used in clinical practice as an adjunct to the pharmacological treatment of CPE.The effect of CPAP is mainly linked to its ability to recruit zones that are collapsed during expiration. • NIPSV combines a positive expiratory pressure to ventilatory assistance pressure during inspiration delivered by a ventilator. It corresponds to a CPAP associated with inspiratory assistance, and thus, it is likely to improve the ventilation parameters, and in particular to reduce respiratory work more efficiently than CPAP alone.These beneficial physiological effects of NIPSV were well demonstrated during the decompensation of COPD ; they wait to be confirmed during CPE. Physiological studies have shown that the NIPSV is more effective in terms of reducing the work of breathing in CPE. However, none of the 7 published randomized studies has shown superiority of the NIPSV compared to CPAP in terms of reducing mortality and intubation requirement
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| continuous positive airway pressure | Active comparator | Device: continuous positive airway pressurerespiratory assistance |
| NIPSV | Active comparator | Device: noninvasive pressure support ventilationrespiratory assistance using face mak and ventilator to provide inspiratory pressure support and positive end expiratory pressure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- All patients aged >18 years and having acute respiratory failure caused by CPE.
- The origin of cardiogenic pulmonary edema is defined according to the history and clinical presentation, the chest X-ray and / or data of echocardiography when they are available with a serum BNP> 100pg/ml.
- The acute respiratory failure is defined by the existence of clinical signs and / or arterial gas parameters:
- sweats and / or agitation and / or signs of struggle and /or drowsiness
- dyspnea with respiratory rate > 35/min,
Key exclusion criteria (5 listed)
- Instability of the hemodynamic state (severe rhythm disturbances, hypotension with systolic arterial pressure <50 mmHg, need for inotropic drugs).
- The need for immediate endotracheal intubation.
- Contraindications to the use of a facial or nasal mask (or facial skin lesion).
- History of recent gastrointestinal surgery or pseudo obstruction.
- Refusal of participation or non-cooperation of the patient.
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 pressureAlso: Boussignac CPAPrespiratory assistance using face mask and positive expiratory pressure apllied by a Boussignac valve | Device | continuous positive airway pressure |
| noninvasive pressure support ventilationAlso: NIPSVnoninvasive pressure support ventilation can provide inspiratory pressure support and expiratory positive pressure | Device | NIPSV |
| noninvasive pressure support ventilationAlso: NIPSVnoninvasive pressure support ventilation provides an inspiratory aid and positive expiratory pressure using ventilator through face mask | Device | NIPSV |
Primary outcome
It is the combination of 3 events: the need for endotracheal intubation, hospital death, and ICU hospitalisation.
Time frame: 6 hours and 30 days after protocol start
Primary outcome It is the combination of 3 events: the need for endotracheal intubation, hospital death, and ICU hospitalisation.
Time frame: 6 hours and 30 days after protocol start
2 secondary outcomes
The change in the rate of troponin
Time frame: 6 hours after protocol start
The length of hospital stay
Time frame: 30 days after protocol start
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 5 Nov 2008.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing continuous positive airway pressure and noninvasive pressure support ventilation in people with Cardiogenic Pulmonary Edema, run by University of Monastir.
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 5 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 5 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
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?
It is the combination of 3 events: the need for endotracheal intubation, hospital death, and ICU hospitalisation. (time frame: 6 hours and 30 days after protocol start). The study lists 2 primary outcomes in all. 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 5 Nov 2008.