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

January 30, 2013 updated by: University of Padova
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Padova, Italy, 35128
        • University Medical Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
180 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Padova

Investigators

  • Principal Investigator: Michele Carron, MD, University medical hospital of Padova

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

March 21, 2011

First Submitted That Met QC Criteria

March 23, 2011

First Posted (Estimate)

March 24, 2011

Study Record Updates

Last Update Posted (Estimate)

January 31, 2013

Last Update Submitted That Met QC Criteria

January 30, 2013

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1926P

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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