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

NCT00603564 | Terminated Results DMC

• 1 other identifier: CAPOVeRSO 01
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumonia; Community-Acquired Infections; Respiratory Insufficiency; Acute Lung Injury

Keywords

CPAP; community-acquired pneumonia; acute respiratory failure; hypoxemia; Continuous Positive Airway Pressure

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• PaO2/FiO2 Ratio Mantainance

  1, 6, 12, 24 and 48 hours

Study Arms (2)

1

ACTIVE COMPARATOR

CPAP delivered by a helmet

Procedure: Castar Starmed (CPAP) delivered by a helmet

2

NO INTERVENTION

O2 administration via a conventional Venturi mask

Interventions

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

Also known as: Castar Starmed CP209/2

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Milan: lead

Study Sites (1)

Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena

Milan, 20122, Italy

Location

Related Publications (3)

• 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.

  PMID: 2403506 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.

  PMID: 11008980 BACKGROUND

• 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.

  PMID: 20154071 DERIVED

MeSH Terms

Conditions

Pneumonia; Community-Acquired Infections; Respiratory Insufficiency; Acute Lung Injury; Community-Acquired Pneumonia; Hypoxia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Lung Injury; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

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.

Results Point of Contact

• Title: Roberto Cosentini, MD
• Organization: IRCCS Fondazione Po.Ma.Re, Milan, Italy

roberto.cosentini@policlinico.mi.it

00390255033602

Study Officials

• roberto cosentini, MD

  Ospedale Maggiore Policlinico Mangiagalli e Regina Elena

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 16, 2008
• First Posted: January 29, 2008
• Study Start: January 1, 2006
• Primary Completion: June 1, 2008
• Study Completion: July 1, 2008
• Last Updated: December 2, 2009
• Results First Posted: December 2, 2009

Record last verified: 2009-10

Locations

IT (1)