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

This study has suspended participant recruitment.
(Very low rate of recruitment anticipated futility of pursuing the study)
Sponsor:
Information provided by:
Corporacion Parc Tauli
ClinicalTrials.gov Identifier:
NCT00243828
First received: October 24, 2005
Last updated: September 5, 2007
Last verified: March 2007
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Corporacion Parc Tauli:

Primary Outcome Measures:
  • Intubation rate

Secondary Outcome Measures:
  • Hospital survival

Estimated Enrollment: 300
Study Start Date: November 2005
Estimated Study Completion Date: December 2007
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00243828     History of Changes
Other Study ID Numbers: CEIC2005/022, AATRM 151/23/2004
Study First Received: October 24, 2005
Last Updated: September 5, 2007
Health Authority: Spain: Ministry of Health and Consumption

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

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

ClinicalTrials.gov processed this record on August 28, 2014