Helmet Continuous Positive Airway Pressure (CPAP) Versus Oxygen Venturi in Severe Acute Respiratory Failure in Pneumonia

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 achievement of criteria for endotracheal intubation during severe acute respiratory failure caused by pneumonia

Detailed Description
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Pneumonia is one of the commonest causes of hospitalised acute respiratory failure with a mortality rate up to 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 by Venturi mask for the treatment of severe acute respiratory failure in patients with pneumonia. .

Official Title
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A Prospective, Randomized, Controlled Trial to Evaluate the Efficacy of CPAP Delivered by Helmet in Comparison With Oxygen Therapy by Venturi Mask in Severe Acute Respiratory Failure Caused by Pneumonia

Conditions
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Pneumonia, Respiratory Insufficiency

Intervention / Treatment
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* Other: Oxygen therapy
* Other: Helmet CPAP


Participation Criteria
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Eligibility Criteria
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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 <7,35 and PaCO2 >45 mmHg; systolic BP <90 mmHg despite fluid resuscitation or vasopressors; severe arrhythmias; convulsions; degree of consciousness, Kelly score>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

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 |
| --- | --- |
| Experimental: CPAP (group A)<br>group A will be treated with CPAP using a helmet, initial PEEP of 10 cmH20 and an FiO2 set in order to maintain SpO2 ≥92% | Other: Helmet CPAP<br>* patient in group CPAP will be treated with CPAP until reaching clinical stability, or criteria of endotracheal intubation<br>|
| Active Comparator: oxygen therapy (group B)<br>group B (standard treatment) will be treated with oxygen therapy by Venturi mask with an FiO2 set in order to maintain SpO2 ≥92%. | Other: Oxygen therapy<br>* patient in group oxygen therapy by Venturi Mask will be treated with oxygen until reaching clinical stability, or criteria of endotracheal intubation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Endotracheale intubation criteria:≥1 among the major criteria or ≥2 among the minor criteria MAJOR CRITERIA:Respiratory arrest;Respiratory pauses with unconsciousness;Severe hemodynamic instability; Need of sedation MINOR CRITERIA:Reduction ≥ 30% of basal PaO2/FiO2; Increasing of 20% PaCO2 if basal PaCO2 is≥40mmHg; Worsening of alertness;Distress;SpO2<90%;Exhaustion. The reaching of these criteria does not automatically imply the actual intubation of the patient, since this decision will depend on the treating physician. | the reaching of the following endotracheal intubation criteria maintained for at least one hour: | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to Compare the Efficacy of the Two Treatments in Terms of In-hospital Mortality | The secondary endpoint of this study will be evaluated, if appropriate, on 3 subpopulations composed of: CPAP: patients randomised to CPAP treatment who have changed treatment only after the reaching of the primary endpoint Control: patients randomised to Venturi mask treatment Mixed: patients who, after the treatment with Venturi mask, have needed to be treated with non-invasive CPAP | participants will be followed for the duration of hospital stay, an expected average of 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Respiratory Failure, Pneumonia, Continuous Positive Airway Pressure