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

University of Milan

Status: Terminated

Conditions: Respiratory Insufficiency; Acute Lung Injury; Community-Acquired Infections; Pneumonia

Treatments: Procedure: Castar Starmed (CPAP) delivered by a helmet

Study type: Interventional

Funder types: Other

Identifiers

NCT00603564

CAPOVeRSO 01

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

Full description

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.

Enrollment: 47 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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47 participants in 2 patient groups

1

Active Comparator group

Description:

CPAP delivered by a helmet

Treatment:

Procedure: Castar Starmed (CPAP) delivered by a helmet

2

No Intervention group

Description:

O2 administration via a conventional Venturi mask