Tracheostomized COPD Patients and Non Invasive Mechanical Ventilation

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01285739
• Other study ID #: MS-12-2010
• Status: Active, not recruiting
• Phase: N/A
• First received: January 27, 2011
• Last updated: November 10, 2011
• Start date: January 2002
• Est. completion date: December 2011

Study information

• Verified date: December 2010
• Source: Fondazione Salvatore Maugeri
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 247
• Est. completion date: December 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• WBC, biomarkers, TBA, chest X ray
The above cited parameters were recorded and investigated every six months; chest X ray when needed.
• WBC, biomarkers, TBA, chest X ray
The above cited parameters were recorded and investigated every six months; chest X ray when needed.

Locations

Country	Name	City	State
Italy	Weaning Center - Fondazione Salvatore Maugeri IRCCS	Montescano	Pavia

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Salvatore Maugeri

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Blood gas analysis	Blood gas analysis	Six months	Yes
Secondary	Care givers involvement	Through a dedicated questionnaire	Six months	No