Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00603564
Other study ID # CAPOVeRSO 01
Secondary ID
Status Terminated
Phase N/A
First received January 16, 2008
Last updated October 26, 2009
Start date January 2006
Est. completion date July 2008

Study information

Verified date October 2009
Source University of Milan
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 47
Est. completion date July 2008
Est. primary completion date June 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Procedure:
Castar Starmed (CPAP) delivered by a helmet
Continuous Positive Airway Pressure delivered by a helmet with PEEP valve of 10 cmH2O and FiO2 0.5

Locations

Country Name City State
Italy Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena Milan

Sponsors (1)

Lead Sponsor Collaborator
University of Milan

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary PaO2/FiO2 Ratio Mantainance 1, 6, 12, 24 and 48 hours No
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04244474 - Effect of Vitamin D Supplementation on Improvement of Pneumonic Children Phase 1/Phase 2
Completed NCT05815264 - Clinical Trial of 23-valent Pneumococcal Polysaccharide Vaccine in Healthy Chinese Population Aged 2 Years and Above Phase 1
Recruiting NCT04589936 - Prone Position to Improve Oxygenation in COVID-19 Patients Outside Critical Care N/A
Completed NCT02905383 - The Effect of Exercise on Physical Function and Health in Older People After Discharge From Hospital N/A
Completed NCT06210737 - A Study to Evaluate Persistence of Immunity of PCV13 in Healthy Population Aged 2 Months,7 Months-5 Years Phase 4
Terminated NCT03944551 - Bubble Continuous Positive Airway Pressure for Children With Severe Pneumonia in Mali, Africa N/A
Terminated NCT04660084 - Impact of Molecular Testing on Improved Diagnosis, Treatment and Management of CAP N/A
Not yet recruiting NCT05649891 - Checklists Resuscitation Emergency Department N/A
Withdrawn NCT05702788 - Efficacy and Safety of Jaktinib in Participants With Severe Novel Coronavirus Pneumonia(COVID-19) Phase 2
Not yet recruiting NCT04171674 - Pharmacokinetics of High-dose Ceftobiprole in Community-acquired Pneumonia Under Mechanical Ventilation. N/A
Active, not recruiting NCT03140163 - Screening for Pneumonia: A Comparison of Ultra Low Dose Chest CT [ULD-CT] and Conventional Chest Radiography [CXR] N/A
Completed NCT02638649 - Prehospital Use of Ultrasound in Undifferentiated Shortness of Breath
Completed NCT02864420 - Hospitalization at Home: The Acute Care Home Hospital Program for Adults N/A
Recruiting NCT02515565 - Physiotherapy in Patients Hospitalized Due to Pneumonia. N/A
Completed NCT02105298 - Effect of Volume and Type of Fluid on Postoperative Incidence of Respiratory Complications and Outcome (CRC-Study) N/A
Completed NCT01399723 - Amoxicillin Versus Benzyl Penicillin for Treatment of Children Hospitalised With Severe Pneumonia Phase 3
Completed NCT01416519 - Physiotherapy Technique Decreases Respiratory Complications After Cardiac Operation N/A
Completed NCT01446926 - Study of Investigational Pneumococcal Vaccine in Healthy Adults, Toddlers and Infants Phase 1
Completed NCT01416506 - Community-Acquired Pneumonia (CAP) Surveillance N/A
Completed NCT01476995 - Prognostic Indicators as Provided by the EPIC ClearView N/A