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

University of Padova

Status: Completed

Conditions: Inadequate or Impaired Breathing Pattern or Ventilation

Treatments: Device: Helmet; Device: Endotracheal tube

Study type: Interventional

Funder types: Other

Identifiers

NCT01322659

1926P

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

Helmet NPPV

Active Comparator group

Description:

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

Treatment:

Device: Helmet

ETT IMV

Sham Comparator group

Description:

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

Treatment:

Device: Endotracheal tube