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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Helmet NPPV | Active Comparator | Weaning from mechanical ventilation with noninvasive positive pressure ventilation (NPPV)delivered by means of the helmet |
|
| ETT IMV | Sham Comparator | Weaning from mechanical ventilation with standard invasive mechanical ventilation (IMV) delivered by means of the endotracheal tube (ETT) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Helmet | Device | Weaning from mechanical ventilation with noninvasive positive pressure ventilation delivered by means of the helmet |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Weaning using noninvasive positive pressure ventilation by means of helmet in patients with acute respiratory failure |
| 180 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michele Carron, MD | University medical hospital of Padova | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Hospital | Padova | 35128 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24793658 | Derived | 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. |
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| ID | Term |
|---|---|
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D006260 | Head Protective Devices |
| ID | Term |
|---|---|
| D000067393 | Personal Protective Equipment |
| D011482 | Protective Devices |
| D004864 | Equipment and Supplies |
| D008420 | Manufactured Materials |
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| Endotracheal tube | Device | Weaning from mechanical ventilation with invasive mechanical ventilation delivered by means of the endotracheal tube |
|
| D013676 | Technology, Industry, and Agriculture |