Tracheostomized COPD Patients and Non Invasive Mechanical Ventilation

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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).

Condition or disease	Intervention/treatment
Chronic Obstructive Pulmonary Disease (COPD)	Other: WBC, biomarkers, TBA, chest X ray

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 Design

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Observational
Actual Enrollment :	247 participants
Observational Model:	Case Control
Time Perspective:	Prospective
Official Title:	Eight-year Follow up in Tracheostomized COPD Patients Undergoing Domiciliary Non Invasive Mechanical Ventilation.
Study Start Date :	January 2002
Actual Primary Completion Date :	September 2011
Estimated Study Completion Date :	December 2011

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort	Intervention/treatment
NIMV COPD; 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; The above cited parameters were recorded and investigated every six months; chest X ray when needed.; Other Name: PCT; CRP
IMV COPD; 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; The above cited parameters were recorded and investigated every six months; chest X ray when needed.; Other Name: PCT; CPR

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. ventilator associated pneumonia (VAP) [ Time Frame: 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 :

1. Blood gas analysis [ Time Frame: Six months ]
   Blood gas analysis
2. Care givers involvement [ Time Frame: Six months ]
   Through a dedicated questionnaire

Biospecimen Retention:   Samples Without DNA

whole blood, tracheobronchial aspirate (TBA)

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	50 Years to 85 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Cohort was selected from patients admitted to Weaning Center. Patients weaned from invasive mechanical ventilation but who needed to keep endotracheal canula were enrolled for the study. Patients with COPD, tracheostomized and in domiciliary invasive mechanical ventilation was the control group.

Criteria

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

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Italy
Weaning Center - Fondazione Salvatore Maugeri IRCCS
Montescano, Pavia, Italy, 27040

Sponsors and Collaborators

Fondazione Salvatore Maugeri

Investigators

Principal Investigator:	Ercole Zanotti, MD	Fondazione Salvatore Maugeri

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Ercole Zanotti, MD, Fondazione Salvatore Maugeri
ClinicalTrials.gov Identifier:	NCT01285739 History of Changes
Other Study ID Numbers:	MS-12-2010
First Posted:	January 28, 2011
Last Update Posted:	November 11, 2011
Last Verified:	December 2010

Keywords provided by Ercole Zanotti, Fondazione Salvatore Maugeri:

Pulmonary Disease, Chronic Obstructive.; Tracheostomy.; Invasive Mechanical Ventilation.; Non-Invasive Mechanical Ventilation.

Additional relevant MeSH terms:

Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiratory Tract Diseases