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Weaning Using Noninvasive Positive Pressure Ventilation by Means of Helmet in Patients With Acute Respiratory Failure

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01322659
First Posted: March 24, 2011
Last Update Posted: January 31, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Padova
  Purpose
The purpose of this study is to determine whether helmet is effective as device for noninvasive positive pressure ventilation in the weaning from mechanical ventilation.

Condition Intervention
Inadequate or Impaired Breathing Pattern or Ventilation Device: Helmet Device: Endotracheal tube

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Weaning Using Noninvasive Positive Pressure Ventilation by Means of Helmet in Patients With Acute Respiratory Failure

Resource links provided by NLM:


Further study details as provided by University of Padova:

Primary Outcome Measures:
  • Weaning using noninvasive positive pressure ventilation by means of helmet in patients with acute respiratory failure [ Time Frame: 30 days ]
    Main end-point defined as the weaning success/failure rate


Secondary Outcome Measures:
  • Weaning using noninvasive positive pressure ventilation by means of helmet in patients with acute respiratory failure [ Time Frame: 180 days ]
    • Intubation duration
    • Total duration of mechanical ventilation (endotracheal and non invasive)
    • Weaning process duration
    • Stress response evaluation
    • Daily duration of ventilatory support
    • ICU lentgh of stay
    • Hospital lentgh of stay


Enrollment: 250
Study Start Date: March 2010
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Helmet NPPV
Weaning from mechanical ventilation with noninvasive positive pressure ventilation (NPPV)delivered by means of the helmet
Device: Helmet
Weaning from mechanical ventilation with noninvasive positive pressure ventilation delivered by means of the helmet
Sham Comparator: ETT IMV
Weaning from mechanical ventilation with standard invasive mechanical ventilation (IMV) delivered by means of the endotracheal tube (ETT)
Device: Endotracheal tube
Weaning from mechanical ventilation with invasive mechanical ventilation delivered by means of the endotracheal tube

Detailed Description:
The clinical efficacy of noninvasive positive pressure ventilation (NPPV) has been demonstrated. Interest has emerged in using NPPV to facilitate earlier removal of an endotracheal tube and decrease complications associated with prolonged intubation. Studies assessing NPPV in weaning are not enough and generally are performed with face masks as device for NPPV. This study assesses the efficacy of helmet as device for NPPV during weaning from mechanical ventilation in an ICU and compares this procedure with invasive mechanical complication (IMV) by analyzing respiratory parameters, clinical course and complications.
  Eligibility

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

Inclusion Criteria:

  • endotracheal mechanical ventilation for 48 hours or more for acute respiratory failure,
  • patient ready to be weaned (steady respiratory and hemodynamic conditions for 24 hours),
  • spontaneous breathing trial failure
  • written informed consent obtained (patient or family)

Exclusion Criteria:

  • respiratory and hemodynamic instability
  • initial difficult intubation
  • bronchial hypersecretion at the weaning time
  • non cooperant patient
  • recent history of upper gastro-intestinal surgery
  • recent history of myocardial infarction
  Contacts and Locations
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): NCT01322659


Locations
Italy
University Medical Hospital
Padova, Italy, 35128
Sponsors and Collaborators
University of Padova
Investigators
Principal Investigator: Michele Carron, MD University medical hospital of Padova
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Padova
ClinicalTrials.gov Identifier: NCT01322659     History of Changes
Other Study ID Numbers: 1926P
First Submitted: March 21, 2011
First Posted: March 24, 2011
Last Update Posted: January 31, 2013
Last Verified: March 2011

Keywords provided by University of Padova:
Mechanical ventilation
Weaning
Noninvasive ventilation
Acute respiratory failure
Helmet

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