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

NCT ID: NCT01322659

Last Updated: 2013-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2013-01-31

Brief Summary

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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

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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.

Conditions

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Inadequate or Impaired Breathing Pattern or Ventilation

Keywords

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Mechanical ventilation Weaning Noninvasive ventilation Acute respiratory failure Helmet

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Helmet NPPV

Weaning from mechanical ventilation with noninvasive positive pressure ventilation (NPPV)delivered by means of the helmet

Group Type ACTIVE_COMPARATOR

Helmet

Intervention Type DEVICE

Weaning from mechanical ventilation with noninvasive positive pressure ventilation delivered by means of the helmet

ETT IMV

Weaning from mechanical ventilation with standard invasive mechanical ventilation (IMV) delivered by means of the endotracheal tube (ETT)

Group Type SHAM_COMPARATOR

Endotracheal tube

Intervention Type DEVICE

Weaning from mechanical ventilation with invasive mechanical ventilation delivered by means of the endotracheal tube

Interventions

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Helmet

Weaning from mechanical ventilation with noninvasive positive pressure ventilation delivered by means of the helmet

Intervention Type DEVICE

Endotracheal tube

Weaning from mechanical ventilation with invasive mechanical ventilation delivered by means of the endotracheal tube

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Padova

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michele Carron, MD

Role: PRINCIPAL_INVESTIGATOR

University medical hospital of Padova

Locations

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University Medical Hospital

Padua, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 24793658 (View on PubMed)

Other Identifiers

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1926P

Identifier Type: -

Identifier Source: org_study_id