N/A
Completed N=81
Helmet Continuous Positive Airway Pressure (CPAP) Versus Oxygen Venturi in Severe Acute Respiratory Failure in Pneumonia
Pneumonia · Respiratory Insufficiency
Source: ClinicalTrials.gov NCT01383213 ↗
Enrolled (actual)
81
Serious AEs
11.1%
Results posted
Feb 2014
Primary outcomePrimary: to Evaluate the Efficacy of CPAP (Group A) in Comparison With Oxygen Therapy With Venturi Mask (Group B, Standard Therapy) in Terms of Achievement of Criteria for Endotracheal Intubation. — 6; 26 participants
Summary
The purpose of this study is to compare the efficacy of CPAP application by a helmet and O2 administration by a Venturi mask in terms of achievement of criteria for endotracheal intubation during severe acute respiratory failure caused by pneumonia
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY to Evaluate the Efficacy of CPAP (Group A) in Comparison With Oxygen Therapy With Venturi Mask (Group B, Standard Therapy) in Terms of Achievement of Criteria for Endotracheal Intubation. |
6; 26 | — |
| SECONDARY to Compare the Efficacy of the Two Treatments in Terms of In-hospital Mortality |
— | — |
Eligibility Criteria
Inclusion Criteria
- men and women of any ethnic group;
- age ≥18 years;
- dyspnoea at rest with respiratory rate (RR) ≥30 breath/min or sign of respiratory distress
- PaO2/FiO2 ratio≤250 evaluated during oxygen therapy supplied at least 1 hour through a Venturi mask with FiO2 ≥0,50
- diagnosis of pneumonia as unique cause of severe acute respiratory failure
- informed consent from each patient or from the closest relative in case of the patient's incapacity to give it
Exclusion Criteria
- diagnosis of other causes of severe acute respiratory failure
- unstable angina or acute myocardial infarction;
- acute respiratory acidosis with pH 45 mmHg;
- systolic BP 3;
- swallowing disturbance with increasing risk of aspiration pneumonia;
- inability to protect the airway;
- recent facial trauma or burn;
- non-collaborative patient;
- presence of open wounds (head, thorax, abdomen);
- respiratory arrest or need of intubation;
- pregnancy or suspect of pregnancy
Data sourced from ClinicalTrials.gov (NCT01383213). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.