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

Respiratory Insufficiency Clinical Trial

Official title:

Assessment of the Effectivity of Total-face Mask for Noninvasive Ventilation During Acute Respiratory Failure: a Randomized Controlled Trial.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00243828
• Other study ID #: CEIC2005/022
• Secondary ID: AATRM 151/23/200
• Status: Terminated
• Phase: Phase 4
• First received: October 24, 2005
• Last updated: September 14, 2015
• Start date: November 2005
• Est. completion date: December 2007

Study information

• Verified date: March 2007
• Source: Corporacion Parc Tauli
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health and Consumption
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 300
• Est. completion date: December 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pulmonary Valve Insufficiency
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency

Intervention

Device:
• Total Face Mask

Locations

Country	Name	City	State
Spain	Hospital de Sabadell	Sabadell	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Corporacion Parc Tauli

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intubation rate
Secondary	Hospital survival