Overview

This trial is active, not recruiting.

Condition chronic obstructive pulmonary disease (copd)
Treatments wbc, biomarkers, tba, chest x ray
Sponsor Fondazione Salvatore Maugeri
Start date January 2002
End date September 2011
Trial size 247 participants
Trial identifier NCT01285739, MS-12-2010

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
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
wbc, biomarkers, tba, chest x ray PCT; CRP
The above cited parameters were recorded and investigated every six months; chest X ray when needed.
Patients with chronic obstructive pulmonary disease (COPD), who underwent tracheostomy for acute respiratory failure and who were discharged in domiciliary invasive mechanical ventilation (IMV)
wbc, biomarkers, tba, chest x ray PCT; CPR
The above cited parameters were recorded and investigated every six months; chest X ray when needed.

Primary Outcomes

Measure
ventilator associated pneumonia (VAP)
time frame: six months

Secondary Outcomes

Measure
Blood gas analysis
time frame: Six months
Care givers involvement
time frame: Six months

Eligibility Criteria

Male or female participants from 50 years up to 85 years old.

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

Additional Information

Official title Eight-year Follow up in Tracheostomized COPD Patients Undergoing Domiciliary Non Invasive Mechanical Ventilation.
Principal investigator Ercole Zanotti, MD
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).
Trial information was received from ClinicalTrials.gov and was last updated in November 2011.
Information provided to ClinicalTrials.gov by Fondazione Salvatore Maugeri.