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

University of Milan

Status: Completed

Conditions: Respiratory Insufficiency; Pneumonia

Treatments: Other: Helmet CPAP; Other: Oxygen therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01383213

SCAPOVERSO

Details and patient eligibility

About

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

Full description

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. .

Enrollment: 81 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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81 participants in 2 patient groups

CPAP (group A)

Experimental group

Description:

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%

Treatment:

Other: Helmet CPAP

oxygen therapy (group B)

Active Comparator group

Description:

group B (standard treatment) will be treated with oxygen therapy by Venturi mask with an FiO2 set in order to maintain SpO2 ≥92%.

Treatment:

Other: Oxygen therapy