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

Pneumonia Clinical Trial

— CAPOVeRSO  

Official title:

A Comparison of CPAP Delivered by Helmet and O2 Therapy With Venturi Mask for the Treatment of Acute Respiratory Failure in Community-acquired Pneumonia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00603564
• Other study ID #: CAPOVeRSO 01
• Status: Terminated
• Phase: N/A
• First received: January 16, 2008
• Last updated: October 26, 2009
• Start date: January 2006
• Est. completion date: July 2008

Study information

• Verified date: October 2009
• Source: University of Milan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 47
• Est. completion date: July 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lung Injury
• Community-Acquired Infections
• Lung Injury
• Pneumonia
• Pulmonary Valve Insufficiency
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency

Intervention

Procedure:
• Castar Starmed (CPAP) delivered by a helmet
Continuous Positive Airway Pressure delivered by a helmet with PEEP valve of 10 cmH2O and FiO2 0.5

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena	Milan

Sponsors (1)

Lead Sponsor	Collaborator
University of Milan

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Gregg RW, Friedman BC, Williams JF, McGrath BJ, Zimmerman JE. Continuous positive airway pressure by face mask in Pneumocystis carinii pneumonia. Crit Care Med. 1990 Jan;18(1):21-4. — View Citation

Hilbert G, Gruson D, Vargas F, Valentino R, Chene G, Boiron JM, Pigneux A, Reiffers J, Gbikpi-Benissan G, Cardinaud JP. Noninvasive continuous positive airway pressure in neutropenic patients with acute respiratory failure requiring intensive care unit admission. Crit Care Med. 2000 Sep;28(9):3185-90. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	PaO2/FiO2 Ratio Mantainance		1, 6, 12, 24 and 48 hours	No