PneumoniaCAPOVeRSONCT00603564
Helmet Continuous Positive Airway Pressure Versus Oxygen Venturi in Acute Respiratory Failure in CAP: CAPOVeRSO
A study testing Castar Starmed (CPAP) delivered by a helmet in people with Pneumonia and Community-Acquired Infections, run by University of Milan at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Community-Acquired Infections, Respiratory Insufficiency
- What is being tested?
- Castar Starmed (CPAP) delivered by a helmet
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2006to Jul 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
Italy1 site
Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena
Milan, 20122
About this study
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
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.
Read the 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.
- Being tested
- Castar Starmed (CPAP) delivered by a helmet
- Keywords
- CPAP, community-acquired pneumonia, acute respiratory failure, hypoxemia, Continuous Positive Airway Pressure
- Medical subject headings
- Pneumonia, Community-Acquired Infections, Respiratory Insufficiency, Acute Lung Injury, Community-Acquired Pneumonia, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Castar Starmed (CPAP) delivered by a helmetProcedure or surgery
Also called Castar Starmed CP209/2
Continuous Positive Airway Pressure delivered by a helmet with PEEP valve of 10 cmH2O and FiO2 0.5
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | CPAP delivered by a helmet Receives: Procedure: Castar Starmed (CPAP) delivered by a helmet |
| 2 | No intervention | O2 administration via a conventional Venturi mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Reach an Improvement in Terms of Gas Exchange, Defined as a PaO2/FiO2 Ratio ≥315
Measured: on admission and at 1, 6, 12, 24 and 48 hours until PaO2/FiO2 ratio ≥315
Secondary outcomes (1)
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
Measured: 1, 6, 12, 24 and 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2008 (estimated)
- Study startJan 2006
- Primary completionJun 2008
- Study completionJul 2008
Why it stopped: The study was prematurely interrupted because patients randomized to CPAP reached the endpoint quicker than anticipated in the protocol
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Investigators
- roberto cosentini, MD, Study chair, Ospedale Maggiore Policlinico Mangiagalli e Regina Elena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00603564
- Sponsor's protocol ID
- CAPOVeRSO 01
- Acronym
- CAPOVeRSO
- Status last verified
- Oct 2009
- First submitted
- 16 Jan 2008
- Last updated
- 2 Dec 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 2403506Hilbert 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.
PubMed 11008980Cosentini 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.
PubMed 20154071
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00603564
- Acronym / sponsor ID
- CAPOVeRSO / CAPOVeRSO 01
- Keywords
- CPAP, community-acquired pneumonia, acute respiratory failure, hypoxemia, Continuous Positive Airway Pressure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was prematurely interrupted because patients randomized to CPAP reached the endpoint quicker than anticipated in the protocol
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 29 Jan 2008 (estimated)
- Results
- Posted 2 Dec 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Castar Starmed (CPAP) delivered by a helmetCPAP delivered by a helmet |
| 2 | No intervention | –O2 administration via a conventional Venturi mask |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Castar Starmed (CPAP) delivered by a helmetAlso: Castar Starmed CP209/2Continuous Positive Airway Pressure delivered by a helmet with PEEP valve of 10 cmH2O and FiO2 0.5 | Procedure or surgery | 1 |
Primary outcome
Time to Reach an Improvement in Terms of Gas Exchange, Defined as a PaO2/FiO2 Ratio ≥315
Time frame: on admission and at 1, 6, 12, 24 and 48 hours until PaO2/FiO2 ratio ≥315
1 secondary outcome
PaO2/FiO2 Ratio Mantainance
Time frame: 1, 6, 12, 24 and 48 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2009.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 2403506Gregg 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.
- Background: PubMed 11008980Hilbert 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.
- Derived from this study: PubMed 20154071Cosentini 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
roberto cosentini, MD study chair
Ospedale Maggiore Policlinico Mangiagalli e Regina Elena
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Castar Starmed (CPAP) delivered by a helmet in people with Pneumonia and Community-Acquired Infections, run by University of Milan at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Dec 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Reach an Improvement in Terms of Gas Exchange, Defined as a PaO2/FiO2 Ratio ≥315 (time frame: on admission and at 1, 6, 12, 24 and 48 hours until PaO2/FiO2 ratio ≥315). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00603564, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2009.