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

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ClinicalTrials.gov Identifier: NCT00243828
Recruitment Status : Terminated (Very low rate of recruitment anticipated futility of pursuing the study)
First Posted : October 25, 2005
Last Update Posted : September 15, 2015
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Respiratory Insufficiency Device: Total Face Mask Phase 4

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 Type : Interventional  (Clinical Trial)
Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of the Effectivity of Total-face Mask for Noninvasive Ventilation During Acute Respiratory Failure: a Randomized Controlled Trial.
Study Start Date : November 2005
Actual Primary Completion Date : September 2007
Actual Study Completion Date : December 2007





Primary Outcome Measures :
  1. Intubation rate

Secondary Outcome Measures :
  1. Hospital survival


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00243828


Locations
Spain
Hospital de Sabadell
Sabadell, Barcelona, Spain, 08208
Sponsors and Collaborators
Corporacion Parc Tauli
Investigators
Study Director: Rafael Fernandez, MD, PhD Corporacion Parc Tauli

ClinicalTrials.gov Identifier: NCT00243828     History of Changes
Other Study ID Numbers: CEIC2005/022
AATRM 151/23/2004
First Posted: October 25, 2005    Key Record Dates
Last Update Posted: September 15, 2015
Last Verified: March 2007

Keywords provided by Corporacion Parc Tauli:
Noninvasive Mechanical Ventilation
Acute Respiratory Failure
Intubation

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiratory Distress Syndrome, Adult
Pulmonary Valve Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases