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The study was prematurely interrupted because patients randomized to CPAP reached the endpoint quicker than anticipated in the protocol
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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 gas exchanges improvement in patients with acute respiratory failure due to community-acquired pneumonia.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | CPAP delivered by a helmet |
|
| 2 | No Intervention | O2 administration via a conventional Venturi mask |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Castar Starmed (CPAP) delivered by a helmet | Procedure | Continuous Positive Airway Pressure delivered by a helmet with PEEP valve of 10 cmH2O and FiO2 0.5 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| PaO2/FiO2 Ratio Mantainance | the number of subjects who could maintain, once reached, a PaO2/FiO2 ratio ≥315 at 1 and 24 hours after the qualifying measurement | 1, 6, 12, 24 and 48 hours |
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Inclusion Criteria:
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| roberto cosentini, MD | Ospedale Maggiore Policlinico Mangiagalli e Regina Elena | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena | Milan | 20122 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 2403506 | Background | 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. | |
| 11008980 | Background | 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. |
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The Steering Committee requested an interim analysis at 20% enrollment in order to monitor the criteria for actual equipoise of the two treatments. Being this unplanned, the Lan-DeMets approach was followed and a manifest superiority of the CPAP treatment was identified, with a nominal alpha exceeding the criterion for interruption set at 0.00008.
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| ID | Title | Description |
|---|---|---|
| FG000 | CPAP (Continuous Positive Airway Pressure) | CPAP delivered by a helmet |
| FG001 | Venturi | O2 administration via a conventional Venturi mask |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 20154071 | Derived | 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. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | CPAP (Continuous Positive Airway Pressure) | CPAP delivered by a helmet |
| BG001 | Venturi | O2 administration via a conventional Venturi mask |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Reach an Improvement in Terms of Gas Exchange, Defined as a PaO2/FiO2 Ratio ≥315 | Posted | Mean | Standard Deviation | minute | on admission and at 1, 6, 12, 24 and 48 hours until PaO2/FiO2 ratio ≥315 |
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| Secondary | PaO2/FiO2 Ratio Mantainance | the number of subjects who could maintain, once reached, a PaO2/FiO2 ratio ≥315 at 1 and 24 hours after the qualifying measurement | Posted | Number | participants | 1, 6, 12, 24 and 48 hours |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CPAP (Continuous Positive Airway Pressure) | CPAP delivered by a helmet | 0 | 20 | 0 | 20 | ||
| EG001 | Venturi | O2 administration via a conventional Venturi mask | 0 | 27 | 0 | 27 |
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Limitations of our study are mainly related to the early reaching of the end-point of the CPAP group. We were not able to evaluate the safety of the CPAP application and to address conclusions on its efficacy on outcomes.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roberto Cosentini, MD | IRCCS Fondazione Po.Ma.Re, Milan, Italy | 00390255033602 | roberto.cosentini@policlinico.mi.it |
| ID | Term |
|---|---|
| D011014 | Pneumonia |
| D017714 | Community-Acquired Infections |
| D012131 | Respiratory Insufficiency |
| D055371 | Acute Lung Injury |
| D000098968 | Community-Acquired Pneumonia |
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D055370 | Lung Injury |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| >=65 years |
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| Male |
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