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

Phase 4

Terminated

• Conditions: Respiratory Insufficiency

• Registration Number: NCT00243828
• Lead Sponsor: Corporacion Parc Tauli

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.

Study Timeline

• Study First Submitted: 2005-10-24
• Study First Submitted QC: 2005-10-24
• Study First Posted: 2005-10-25
• Study Start: 2005-11
• Status Verified: 2007-03
• Primary Completion: 2007-09
• Study Completion: 2007-12
• Last Update Submitted: 2015-09-14
• Last Update Posted: 2015-09-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Intubation rate

Secondary Outcome Measures

Name	Time	Method
Hospital survival

Trial Locations

Locations (1)

Hospital de Sabadell; 🇪🇸 Sabadell, Barcelona, Spain