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| Sponsored by: |
Corporacion Parc Tauli |
|---|---|
| Information provided by: | Corporacion Parc Tauli |
| ClinicalTrials.gov Identifier: | NCT00243828 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Respiratory Insufficiency |
Device: Total Face Mask |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Assessment of the Effectivity of Total-Face Mask for Noninvasive Ventilation During Acute Respiratory Failure: a Randomized Controlled Trial. |
| Estimated Enrollment: | 300 |
| Study Start Date: | November 2005 |
| Estimated Study Completion Date: | December 2007 |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Study ID Numbers: | CEIC2005/022, AATRM 151/23/2004 |
| Study First Received: | October 24, 2005 |
| Last Updated: | September 5, 2007 |
| ClinicalTrials.gov Identifier: | NCT00243828 History of Changes |
| Health Authority: | Spain: Ministry of Health and Consumption |
|
Noninvasive Mechanical Ventilation Acute Respiratory Failure Intubation |
|
Respiratory Insufficiency Respiratory Tract Diseases Facies Lung Diseases |
Respiration Disorders Respiratory Distress Syndrome, Adult Acute Respiratory Distress Syndrome |
|
Respiratory Insufficiency Respiratory Tract Diseases Lung Diseases Respiration Disorders Respiratory Distress Syndrome, Adult |
