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.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

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

Other trials in Italy

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

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.

Conditions: Pneumonia, Community-Acquired Infections, Respiratory Insufficiency, Acute Lung Injury
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 groups in NCT00603564
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.

Jan 2006Jul 2008

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)

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 2403506
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.
PubMed 11008980
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.
PubMed 20154071

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection

All Pneumonia trials

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
Conditions: Pneumonia, Community-Acquired Infections, Respiratory Insufficiency, Acute Lung Injury
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.

Detailed description

Community-acquired pneumonia (CAP) is one of the commonest causes of hospitalised acute respiratory failure with a mortality rate up t 30%.

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

Results posted to the registry on 2 Dec 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CPAP (Continuous Positive Airway Pressure)	20	20
Venturi	27	27

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. Mean (Standard Deviation). Unit: minute

Measure	CPAP (Continuous Positive Airway Pressure) n = 20	Venturi n = 27
Value	405 (855)	2437 (1170)

CPAP (Continuous Positive Airway Pressure) vs Venturi: p <0.001, t-test, 2 sided

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CPAP (Continuous Positive Airway Pressure)	0 of 20 (0%)	0 of 20 (0%)	Not reported
Venturi	0 of 27 (0%)	0 of 27 (0%)	Not reported

Limitations and caveats (from the sponsor): 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.

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.

Related trials for Pneumonia

Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection

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.