Status:
UNKNOWN
Helmet CPAP vs Venturi O2 to Treat Early ALI/ARDS
Lead Sponsor:
Catholic University of the Sacred Heart
Conditions:
Acute Hypoxemic Respiratory Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Mechanical ventilation through an endotracheal tube is a lifesaving procedure for acute respiratory failure. However endotracheal intubation increases patient's discomfort and stress, and represents o...
Detailed Description
Prevention of Endotracheal Intubation by NIV and CPAP Mechanical ventilation through an endotracheal tube is a lifesaving procedure for acute respiratory failure. However endotracheal intubation incre...
Eligibility Criteria
Inclusion
- Acute Hypoxemic Respiratory failure
- Severe Dyspnea at rest
- Pulmonary infiltrates at chest X ray
- PaO2/FiO2\<300
- Respiratory Rate \> 30 breaths/min
Exclusion
- Age \< 18 years
- COPD
- CPE
- Patients belonging to Class II-III-IV of the NYHA
- Unstable angina and myocardial infarction/ cardiac surgery within the previous 3 months
- Intubation refused or contraindicated
- Acute Respiratory Acidosis pH \< 7.30 and PaCO2 \> 50 mmHg
- More than 3 organ failures
- Systolic Pressure \< 90 mmHg, under fluid resuscitation or Epinephrine or Norepinephrine \> 0.1 gamma/Kg/min
- EKG instability with ventricular arrhythmias
- EXPECTED surgery during the 48 hours following the enrollment
- Coma or seizures
- Decreased level of consciousness (GCS \<12)
- Inability to clear secretions
- Pre-defined intubation criteria
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2009
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT00342368
Start Date
June 1 2005
End Date
March 1 2009
Last Update
November 1 2007
Active Locations (1)
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1
UCSC, Policlinico Universitario A. Gemelli, ICU
Rome, Rome, Italy, 00168