Clinical trial NCT00243828: Assessment of the Effectivity of Total-face Mask for Noninvasive Ventilation During Acute Respiratory Failure
Official title: Assessment of the Effectivity of Total-face Mask for Noninvasive Ventilation During Acute Respiratory Failure: a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Respiratory Insufficiency
Keywords: Noninvasive Mechanical Ventilation
Acute Respiratory Failure
Intubation
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2005-10-25
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Intubation rate
Secondary outcomes:
measure: Hospital survival
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Hospital de Sabadell
state: Barcelona
Study officials:
affiliation: Corporacion Parc Tauli
name: Rafael Fernandez, MD, PhD
role: STUDY_DIRECTOR
References: