Inadequate or Impaired Breathing Pattern or Ventilation
Conditions
Keywords
Mechanical ventilation, Weaning, Noninvasive ventilation, Acute respiratory failure, Helmet
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.
Interventions
DEVICEHelmet
Weaning from mechanical ventilation with noninvasive positive pressure ventilation delivered by means of the helmet
DEVICEEndotracheal tube
Weaning from mechanical ventilation with invasive mechanical ventilation delivered by means of the endotracheal tube
Sponsors
University of Padova
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Italy
Outcome results
None listed