Helmet Continuous Positive Airway Pressure Versus Oxygen Venturi in Acute Respiratory Failure in CAP: CAPOVeRSO

Study Overview
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Brief Summary
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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 gas exchanges improvement in patients with acute respiratory failure due to community-acquired pneumonia.

Detailed Description
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Community-acquired pneumonia (CAP) is one of the commonest causes of hospitalised acute respiratory failure with a mortality rate up t 30%. Continuous Positive Airway Pressure (CPAP) has ben recently proved to be effective. To date, however, no prospective randomised study has been published on the comparison between CPAP and O2 administration via a Venturi mask for the treatment of acute respiratory failure in immunocompetent patients with community-acquired pneumonia. Therefore, the aim of this study is to compare the efficacy of CPAP delivered by a helmet and O2 administration via a Venturi mask in terms of gas exchanges improvement in early acute respiratory failure (PaO2/FiO2 between 210 and 285)due to community-acquired pneumonia. A Steering Committee composed by the principal investigators will request an interim analysis at 20% enrolment in order to monitor the criteria for equipoise of the two treatments.

Official Title
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A Comparison of CPAP Delivered by Helmet and O2 Therapy With Venturi Mask for the Treatment of Acute Respiratory Failure in Community-acquired Pneumonia

Conditions
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Community-Acquired Infections, Pneumonia, Respiratory Insufficiency, Acute Lung Injury

Intervention / Treatment
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* Procedure: Castar Starmed (CPAP) delivered by a helmet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Community-acquired pneumonia (CAP) defined as: new chest x-ray pulmonary infiltrate, fever, and respiratory symptoms Acute Hypoxemic Respiratory failure Respiratory Rate < 35 breaths/min PaO2/FiO2 > 200 and < 300 while breathing oxygen for at least 15 minutes via a Venturi mask with FiO2 0.5 Exclusion criteria Immunosuppression acute cardiogenic pulmonary edema Patients belonging to Class II-III-IV of the NYHA Acute coronary syndrome Acute Respiratory Acidosis pH < 7.35 and PaCO2 > 45 mmHg More than 3 acute organ failures Systolic Pressure < 90 mmHg under fluid resuscitation or vasopressor drug use Seizures Decreased level of consciousness (GCS <12) Inability to clear secretions Pre-defined intubation criteria

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>CPAP delivered by a helmet | Procedure: Castar Starmed (CPAP) delivered by a helmet<br>* Continuous Positive Airway Pressure delivered by a helmet with PEEP valve of 10 cmH2O and FiO2 0.5<br>* Other names: Castar Starmed CP209/2;|
| No Intervention: 2<br>O2 administration via a conventional Venturi mask | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Reach an Improvement in Terms of Gas Exchange, Defined as a PaO2/FiO2 Ratio ≥315 |  | on admission and at 1, 6, 12, 24 and 48 hours until PaO2/FiO2 ratio ≥315 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PaO2/FiO2 Ratio Mantainance | the number of subjects who could maintain, once reached, a PaO2/FiO2 ratio ≥315 at 1 and 24 hours after the qualifying measurement | 1, 6, 12, 24 and 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CPAP, community-acquired pneumonia, acute respiratory failure, hypoxemia, Continuous Positive Airway Pressure