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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:
Information provided by (Responsible Party):
University of Padova
ClinicalTrials.gov Identifier:
NCT01322659
First received: March 21, 2011
Last updated: January 30, 2013
Last verified: March 2011
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    • 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University of Padova
ClinicalTrials.gov Identifier: NCT01322659     History of Changes
Other Study ID Numbers: 1926P
Study First Received: March 21, 2011
Last Updated: January 30, 2013
Health Authority: Italy: National Institute of Health

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

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

ClinicalTrials.gov processed this record on May 16, 2013