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

NCT ID: NCT00243828

Last Updated: 2015-09-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-11-30
• Study Completion Date: 2007-12-31

Brief 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.

Detailed Description

HYPOTESIS: 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.OBJECTIVES: To assess, in acute respiratory failure patients, whether the total-face mask reduce the intubation rate. Additionally, whether it may improve mask tolerance, skin pressure damage, number of patients receiving higher pressures, or even a reduction in mortality. 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. PEEp will be titrated to the best oxygenation and IPAP up to reduce dyspnea and respiratory frequency, with the limits at clinical tolerance and massive leaks. Defined failure criteria and weaning technique will be used. Data to record include clinical parameters and mortality risk score (SAPS II), and physiologic response to NIV (either subjective and objective), technique failures and outcome. EXPECTED RESULTS: The study has been powered to detect a 30% relative improvement in intubation rate from a 35% baseline incidence of intubation in the conventional group.

Conditions

Respiratory Insufficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Total Face Mask

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Acute Hypoxemia:PaO2/FiO2 lower than 200 mmHg
• Respiratory rate greater than 30 breaths/min

Exclusion Criteria

• cardiogenic lung edema
• COPD exacerbation
• Low level of consciousness (GCS < 13)
• Hemodynamic instability
• Facial damage
• Do-not-intubate orders
• Lack of informed consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Corporacion Parc Tauli

OTHER

Sponsor Role: lead

Principal Investigators

Rafael Fernandez, MD, PhD

Role: STUDY_DIRECTOR

Corporacion Parc Tauli

Locations

Hospital de Sabadell

Sabadell, Barcelona, Spain

Countries

Spain

Other Identifiers

AATRM 151/23/2004

Identifier Type: -

Identifier Source: secondary_id

CEIC2005/022

Identifier Type: -

Identifier Source: org_study_id