Back to resultsWeaning Using Noninvasive Positive Pressure Ventilation by Means of Helmet in Patients With Acute Respiratory Failure
Primary Purpose
Inadequate or Impaired Breathing Pattern or Ventilation
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Helmet
Endotracheal tube
Sponsored by
About this trial
This is an interventional treatment trial for Inadequate or Impaired Breathing Pattern or Ventilation focused on measuring Mechanical ventilation, Weaning, Noninvasive ventilation, Acute respiratory failure, Helmet
Eligibility 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
Sites / Locations
- University Medical Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Helmet NPPV
ETT IMV
Arm Description
Weaning from mechanical ventilation with noninvasive positive pressure ventilation (NPPV)delivered by means of the helmet
Weaning from mechanical ventilation with standard invasive mechanical ventilation (IMV) delivered by means of the endotracheal tube (ETT)
Outcomes
Primary Outcome Measures
Weaning using noninvasive positive pressure ventilation by means of helmet in patients with acute respiratory failure
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01322659
Brief Title
Weaning Using Noninvasive Positive Pressure Ventilation by Means of Helmet in Patients With Acute Respiratory Failure
Official Title
Weaning Using Noninvasive Positive Pressure Ventilation by Means of Helmet in Patients With Acute Respiratory Failure
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Padova
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inadequate or Impaired Breathing Pattern or Ventilation
Keywords
Mechanical ventilation, Weaning, Noninvasive ventilation, Acute respiratory failure, Helmet
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Helmet NPPV
Arm Type
Active Comparator
Arm Description
Weaning from mechanical ventilation with noninvasive positive pressure ventilation (NPPV)delivered by means of the helmet
Arm Title
ETT IMV
Arm Type
Sham Comparator
Arm Description
Weaning from mechanical ventilation with standard invasive mechanical ventilation (IMV) delivered by means of the endotracheal tube (ETT)
Intervention Type
Device
Intervention Name(s)
Helmet
Intervention Description
Weaning from mechanical ventilation with noninvasive positive pressure ventilation delivered by means of the helmet
Intervention Type
Device
Intervention Name(s)
Endotracheal tube
Intervention Description
Weaning from mechanical ventilation with invasive mechanical ventilation delivered by means of the endotracheal tube
Primary Outcome Measure Information:
Title
Weaning using noninvasive positive pressure ventilation by means of helmet in patients with acute respiratory failure
Description
Main end-point defined as the weaning success/failure rate
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Weaning using noninvasive positive pressure ventilation by means of helmet in patients with acute respiratory failure
Description
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
Time Frame
180 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michele Carron, MD
Organizational Affiliation
University medical hospital of Padova
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Hospital
City
Padova
ZIP/Postal Code
35128
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
24793658
Citation
Carron M, Rossi S, Carollo C, Ori C. Comparison of invasive and noninvasive positive pressure ventilation delivered by means of a helmet for weaning of patients from mechanical ventilation. J Crit Care. 2014 Aug;29(4):580-5. doi: 10.1016/j.jcrc.2014.03.035. Epub 2014 Apr 5.
Results Reference
derived
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Weaning Using Noninvasive Positive Pressure Ventilation by Means of Helmet in Patients With Acute Respiratory Failure
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