Clinical trial NCT00603564: Helmet Continuous Positive Airway Pressure Versus Oxygen Venturi in Acute Respiratory Failure in CAP: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pneumonia
Community-Acquired Infections
Respiratory Insufficiency
Acute Lung Injury
Keywords: CPAP
community-acquired pneumonia
acute respiratory failure
hypoxemia
Continuous Positive Airway Pressure
Lead sponsor: University of Milan
Sponsor class: OTHER
First posted: 2008-01-29
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Time to Reach an Improvement in Terms of Gas Exchange, Defined as a PaO2/FiO2 Ratio ≥315
timeFrame: on admission and at 1, 6, 12, 24 and 48 hours until PaO2/FiO2 ratio ≥315
Secondary outcomes:
measure: PaO2/FiO2 Ratio Mantainance
timeFrame: 1, 6, 12, 24 and 48 hours
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena
Study officials:
affiliation: Ospedale Maggiore Policlinico Mangiagalli e Regina Elena
name: roberto cosentini, MD
role: STUDY_CHAIR
References:
citation: 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. doi: 10.1097/00003246-199001000-00006.
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. doi: 10.1097/00003246-200009000-00012.
citation: Cosentini R, Brambilla AM, Aliberti S, Bignamini A, Nava S, Maffei A, Martinotti R, Tarsia P, Monzani V, Pelosi P. Helmet continuous positive airway pressure vs oxygen therapy to improve oxygenation in community-acquired pneumonia: a randomized, controlled trial. Chest. 2010 Jul;138(1):114-20. doi: 10.1378/chest.09-2290. Epub 2010 Feb 12.