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CPAP Versus Bilevel Pressure Support Ventilation in Cardiogenic Pulmonary Edema

CPAP Boussignac Versus Bilevel Pressure Support Ventilation in Severe Acute Cardiogenic Pulmonary Edema

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00213681
Enrollment
Unknown
Registered
2005-09-21
Start date
2002-11-01
Completion date
2005-12-28
Last updated
2026-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Acute Cardiogenic Pulmonary Edema

Keywords

Pulmonary edema, respiratory failure, pressure support ventilation, continuous positive pressure

Brief summary

To evaluate whether bilevel positive airway pressure more rapidly improves ventilation than continuous positive airway pressure (CPAP) in patients with acute pulmonary edema. CPAP is delivered via a simple device connected to oxygen.

Interventions

DEVICEBoussignac CPAP - bilevel ventilation support

Sponsors

University Hospital, Rouen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* age \> 16 yrs, acute onset of severe respiratory distress, bilateral rales and typical findings of congestion on chest radiograph * breathing frequency of \> 30/min, SpO2 \>90%, use of accessory respiratory muscles

Design outcomes

Primary

MeasureTime frame
Improvement in PaCO2 at the end of ventilation

Secondary

MeasureTime frame
Endotracheal intubation, myocardial infarction and mortality during the first 24 hours
Duration of the ventilation
Blood gases, vital signs
Time to transfer to medical ward
Time to hospital discharge
Easiness to use was evaluated by nurses
Patients operational tolerance
Complications of each ventilation mode

Countries

France

Contacts

PRINCIPAL_INVESTIGATORFabienne MORITZ, MD

University Hospital, Rouen

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 5, 2026