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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2013-02-28

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

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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. .

Conditions

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Pneumonia Respiratory Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CPAP (group A)

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%

Group Type EXPERIMENTAL

Helmet CPAP

Intervention Type OTHER

patient in group CPAP will be treated with CPAP until reaching clinical stability, or criteria of endotracheal intubation

oxygen therapy (group B)

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

Group Type ACTIVE_COMPARATOR

Oxygen therapy

Intervention Type OTHER

patient in group oxygen therapy by Venturi Mask will be treated with oxygen until reaching clinical stability, or criteria of endotracheal intubation

Interventions

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Oxygen therapy

patient in group oxygen therapy by Venturi Mask will be treated with oxygen until reaching clinical stability, or criteria of endotracheal intubation

Intervention Type OTHER

Helmet CPAP

patient in group CPAP will be treated with CPAP until reaching clinical stability, or criteria of endotracheal intubation

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No