Tracheostomized COPD Patients and Non Invasive Mechanical Ventilation

Study Overview
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Brief Summary
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The purpose of this study was to determine occurrence of ventilator associated pneumonia (VAP) in tracheostomized patients with COPD discharged in invasive mechanical ventilation (IMV) compared to patients with CPOPD discharged with tracheostomy but in non invasive mechanical ventilation (NIMV).

Detailed Description
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Acute respiratory failure due to COPD is often treated with invasive mechanical ventilation through endotracheal intubation, followed by placement of a endotracheal canula. However, invasive ventilation is at risk of infective complications and is difficult to manage at home. In particular, invasive mechanical ventilation may be associated with ventilator associated pneumonia (VAP). VAP is usually suspected when the individual develops a new or progressive infiltrate on chest radiograph, leukocytosis, and purulent tracheobronchial secretions. When possible, we tried to put these tracheotomized patients in non invasive mechanical ventilation (NIMV)to avoid VAP. This population was followed for eight consecutive years and compared with patients in invasive home mechanical ventilation (IMV).

Official Title
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Eight-year Follow up in Tracheostomized COPD Patients Undergoing Domiciliary Non Invasive Mechanical Ventilation.

Conditions
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Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
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* Other: WBC, biomarkers, TBA, chest X ray
* Other: WBC, biomarkers, TBA, chest X ray


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of COPD Tracheostomy Need of domiciliary invasive / non invasive ventilation Exclusion Criteria: Patients with COPD weaned from invasive / non invasive mechanical ventilation Lack of tracheostomy

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NIMV COPD<br>Patients with chronic obstructive pulmonary disease (COPD), who underwent tracheostomy for acute respiratory failure and who were discharged with tracheostomy but in domiciliary non invasive ventilation | Other: WBC, biomarkers, TBA, chest X ray<br>* The above cited parameters were recorded and investigated every six months; chest X ray when needed.<br>* Other names: PCT; CRP;|
| IMV COPD<br>Patients with chronic obstructive pulmonary disease (COPD), who underwent tracheostomy for acute respiratory failure and who were discharged in domiciliary invasive mechanical ventilation (IMV) | Other: WBC, biomarkers, TBA, chest X ray<br>* The above cited parameters were recorded and investigated every six months; chest X ray when needed.<br>* Other names: PCT; CPR;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ventilator associated pneumonia (VAP) | VAP is usually suspected when the individual develops a new or progressive infiltrate on chest radiograph, leukocytosis, and purulent tracheobronchial secretions. Therefore white cell blood (WBC)count, procalcitonine (PCT), C-reactive protein (CRP) and tracheobronchial aspirate (TBA) were collected every 6 months. Chest X ray was performed only when a clinical suspect of VAP was advanced. | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood gas analysis | Blood gas analysis | Six months | 
| Care givers involvement | Through a dedicated questionnaire | Six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulmonary Disease, Chronic Obstructive., Tracheostomy., Invasive Mechanical Ventilation., Non-Invasive Mechanical Ventilation.