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

Inadequate or Impaired Breathing Pattern or Ventilation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01322659
• Other study ID #: 1926P
• Status: Completed
• Phase: N/A
• First received: March 21, 2011
• Last updated: January 30, 2013
• Start date: March 2010
• Est. completion date: January 2013

Study information

• Verified date: March 2011
• Source: University of Padova
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Institute of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Inadequate or Impaired Breathing Pattern or Ventilation
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency

Intervention

Device:
• Helmet
Weaning from mechanical ventilation with noninvasive positive pressure ventilation delivered by means of the helmet
• Endotracheal tube
Weaning from mechanical ventilation with invasive mechanical ventilation delivered by means of the endotracheal tube

Locations

Country	Name	City	State
Italy	University Medical Hospital	Padova

Sponsors (1)

Lead Sponsor	Collaborator
University of Padova

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	30 days	Yes
Secondary	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	180 days	Yes