Status:
TERMINATED
Continuous Positive Airway Pressure (CPAP) Ventilation Using a Novel Full-Face Mask Versus Conventional Helmet
Lead Sponsor:
University of Parma
Collaborating Sponsors:
Azienda Ospedaliero-Universitaria di Parma
Conditions:
Respiratory Insufficiency
Respiratory Distress Syndrome, Adult
Eligibility:
All Genders
18-89 years
Phase:
NA
Brief Summary
The aim of this study is to compare two methods of delivery of noninvasive mechanical ventilation (NIV). Since patient compliance and mechanical characteristics of the delivery devices are two fundam...
Detailed Description
Noninvasive ventilation (NIV) is the delivery of ventilatory support without the need for an invasive artificial airway. The use of noninvasive positive-pressure ventilation (NPPV) in acute respirator...
Eligibility Criteria
Inclusion
- Ongoing or recent history of respiratory failure (either primary or secondary)
- PaO2 \<60 mmHg if breathing room air or PaO2/FiO2 \<300 mmHg if receiving supplemental oxygen
- Acute dyspnea with respiratory rate \>25 bpm and accessory muscle recruitment and/or paradoxical abdominal breathing
Exclusion
- Refusing noninvasive ventilation
- Comatose (Glasgow Coma Scale \<8) or unable to maintain a patent airway
- Hemodynamically unstable (systolic blood pressure \<80 mmHg on recruitment, or receiving vasopressors/inotropes; ongoing angina/myocardial infarction; newly-developed arrhythmia with hemodynamic impact)
- Having recently (≤2 weeks) undergone oesophageal or upper respiratory tract surgery
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00944437
Start Date
May 1 2008
End Date
July 1 2010
Last Update
November 5 2013
Active Locations (1)
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1
University and Hospital of Parma (Azienda Ospedaliero-Universitaria di Parma)
Parma, PR, Italy, 43126