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Continuous Positive Airway Pressure (CPAP) Ventilation Using a Novel Full-Face Mask Versus Conventional Helmet

NCT00944437 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2013-11-05

No results posted yet for this study

Summary

The aim of this study is to compare two methods of delivery of noninvasive mechanical ventilation (NIV).

Since patient compliance and mechanical characteristics of the delivery devices are two fundamental variables in the success of NIV during acute respiratory failure, our hypothesis is that an improved patient-ventilator interface may improve the efficacy of therapy.

Conditions

Interventions

DEVICE

Helmet

Continuous positive airway pressure for up to 24 h. Initial pressure will be 5 cmH2O, and will be increased by 2-3 cmH2O up to 10 cmH2O, in order to maintain SpO2 ≥90%.

DEVICE

Full-face mask

Continuous positive airway pressure for up to 24 h. Initial pressure will be 5 cmH2O, and will be increased by 2-3 cmH2O up to 10 cmH2O, in order to maintain SpO2 ≥90%.

Sponsors & Collaborators

  • Azienda Ospedaliero-Universitaria di Parma

    collaborator OTHER

  • University of Parma

    lead OTHER

Principal Investigators

  • Guido Fanelli, MD · Dept. of Anesthesiology and Critical Care Medicine, University of Parma, Italy

  • Maria Barbagallo, MD · UO II Anestesia, Rianimazione e Terapia Antalgica, Azienda Ospedaliero-Universitaria di Parma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00944437 on ClinicalTrials.gov