Tracheostomized COPD Patients and Non Invasive Mechanical Ventilation

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

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).

Study Overview

• Status: Unknown
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 247

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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 Names: PCT; CPR
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 Names: PCT; CPR

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fondazione Salvatore Maugeri
• Investigators: Principal Investigator: Ercole Zanotti, md, Fondazione Salvatore Maugeri

Study record dates

Study Major Dates

• Study Start: January 1, 2002
• Primary Completion (Actual): September 1, 2011
• Study Completion (Anticipated): December 1, 2011

Study Registration Dates

• First Submitted: January 27, 2011
• First Submitted That Met QC Criteria: January 27, 2011
• First Posted (Estimate): January 28, 2011

Study Record Updates

• Last Update Posted (Estimate): November 11, 2011
• Last Update Submitted That Met QC Criteria: November 10, 2011
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Keywords: Pulmonary Disease, Chronic Obstructive.; Tracheostomy.; Invasive Mechanical Ventilation.; Non-Invasive Mechanical Ventilation.
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: MS-12-2010

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No