Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
80 participants
INTERVENTIONAL
2002-07-31
2005-05-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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CPAP and Non Invasive Ventilation
Eligibility Criteria
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Inclusion Criteria
* severe dyspnoea at rest
* respiratory rate \> 30 breath per minute
* use of accessory respiratory muscles
* PaO2/FiO2 \< 200, radiological findings of ACPE
Exclusion Criteria
* 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
* pulmonary embolism, pneumonia, recent oesophageal-gastric surgery
* gastrointestinal bleeding
* facial deformities
* haematological malignancy or cancer with Eastern Cooperative Oncology Group (ECOG) performance status ≥ 2.
18 Years
ALL
No
Sponsors
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Ospedale S. Giovanni Bosco
OTHER
Principal Investigators
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Giovanni Ferrari, MD
Role: PRINCIPAL_INVESTIGATOR
Ospedale San Giovanni Bosco ASL4
Giovanni Ferrari, MD
Role: PRINCIPAL_INVESTIGATOR
Ospedale San Giovanni Bosco ASL4 Torino Italy
Locations
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Ospedale San Giovanni Bosco Medicina d'Urgenza
Torino, , Italy
Countries
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Other Identifiers
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gbosco1
Identifier Type: -
Identifier Source: org_study_id