Tracheostomized COPD Patients and Non Invasive Mechanical Ventilation

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Interventions: Other: WBC, biomarkers, TBA, chest X ray

• Registration Number: NCT01285739
• Lead Sponsor: Fondazione Salvatore Maugeri

Brief Summary

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

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).

Study Timeline

• Study Start: 2002-01
• Status Verified: 2010-12
• Study First Submitted: 2011-01-27
• Study First Submitted QC: 2011-01-27
• Study First Posted: 2011-01-28
• Primary Completion: 2011-09
• Last Update Submitted: 2011-11-10
• Last Update Posted: 2011-11-11
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 247

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
IMV COPD	WBC, biomarkers, TBA, chest X ray	Patients with chronic obstructive pulmonary disease (COPD), who underwent tracheostomy for acute respiratory failure and who were discharged in domiciliary invasive mechanical ventilation (IMV)
NIMV COPD	WBC, biomarkers, TBA, chest X ray	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

Primary Outcome Measures

Name	Time	Method
ventilator associated pneumonia (VAP)	six months	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.

Secondary Outcome Measures

Name	Time	Method
Care givers involvement	Six months	Through a dedicated questionnaire
Blood gas analysis	Six months	Blood gas analysis

Trial Locations

Locations (1)

Weaning Center - Fondazione Salvatore Maugeri IRCCS; 🇮🇹 Montescano, Pavia, Italy