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Assessment of the Effectivity of Total-face Mask for Noninvasive Ventilation During Acute Respiratory Failure

NCT00243828 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2015-09-15

No results posted yet for this study

Summary

Total-face mask may improve the efficacy of NIV compared to conventional face mask in patients with acute respiratory failure due to enhanced tolerance and the allowance of higher airway pressure without massive leaks.MAIN OBJECTIVE: To assess, in acute respiratory failure patients, whether the total-face mask reduce the intubation rate. METHODS: 300 patients admitted in the ICU for acute respiratory failure needing continuous noninvasive mechanical ventilation. The type of mask (total-face vs. conventional face mask) will be randomized. Defined failure criteria and weaning technique will be used.

Conditions

  • Respiratory Insufficiency

Interventions

DEVICE

Total Face Mask

Sponsors & Collaborators

  • Corporacion Parc Tauli

    lead OTHER

Principal Investigators

  • Rafael Fernandez, MD, PhD · Corporacion Parc Tauli

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2007-09-30
Completion
2007-12-31

Countries

  • Spain

Study Locations

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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 NCT00243828 on ClinicalTrials.gov