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

Not Applicable

Terminated

• Conditions: Pneumonia; Community-Acquired Infections; Respiratory Insufficiency; Acute Lung Injury
• Interventions: Procedure: Castar Starmed (CPAP) delivered by a helmet

• Registration Number: NCT00603564
• Lead Sponsor: University of Milan

Brief Summary

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

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.

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2008-01-16
• Study First Submitted QC: 2008-01-28
• Study First Posted: 2008-01-29
• Primary Completion: 2008-06
• Study Completion: 2008-07
• Results First Submitted: 2009-09-11
• Status Verified: 2009-10
• Results First Submitted QC: 2009-10-26
• Last Update Submitted: 2009-10-26
• Results First Posted: 2009-12-02
• Last Update Posted: 2009-12-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 47

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Castar Starmed (CPAP) delivered by a helmet	CPAP delivered by a helmet

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
PaO2/FiO2 Ratio Mantainance	1, 6, 12, 24 and 48 hours	the number of subjects who could maintain, once reached, a PaO2/FiO2 ratio ≥315 at 1 and 24 hours after the qualifying measurement

Trial Locations

Locations (1)

Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena; 🇮🇹 Milan, Italy