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

Not Applicable

Completed

• Conditions: Inadequate or Impaired Breathing Pattern or Ventilation
• Interventions: Device: Helmet; Device: Endotracheal tube

• Registration Number: NCT01322659
• Lead Sponsor: University of Padova

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.

Study Timeline

• Study Start: 2010-03
• Status Verified: 2011-03
• Study First Submitted: 2011-03-21
• Study First Submitted QC: 2011-03-23
• Study First Posted: 2011-03-24
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Last Update Submitted: 2013-01-30
• Last Update Posted: 2013-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Helmet NPPV	Helmet	Weaning from mechanical ventilation with noninvasive positive pressure ventilation (NPPV)delivered by means of the helmet
ETT IMV	Endotracheal tube	Weaning from mechanical ventilation with standard invasive mechanical ventilation (IMV) delivered by means of the endotracheal tube (ETT)

Primary Outcome Measures

Name	Time	Method
Weaning using noninvasive positive pressure ventilation by means of helmet in patients with acute respiratory failure	30 days	Main end-point defined as the weaning success/failure rate

Secondary Outcome Measures

Name	Time	Method
Weaning using noninvasive positive pressure ventilation by means of helmet in patients with acute respiratory failure	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

Trial Locations

Locations (1)

University Medical Hospital; 🇮🇹 Padova, Italy