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Tracheostomized COPD Patients and Non Invasive Mechanical Ventilation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Fondazione Salvatore Maugeri.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Ercole Zanotti, Fondazione Salvatore Maugeri
ClinicalTrials.gov Identifier:
NCT01285739
First received: January 27, 2011
Last updated: November 10, 2011
Last verified: December 2010
History of Changes
  Purpose

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

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Eight-year Follow up in Tracheostomized COPD Patients Undergoing Domiciliary Non Invasive Mechanical Ventilation.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Fondazione Salvatore Maugeri:

Primary Outcome Measures:
  • ventilator associated pneumonia (VAP) [ Time Frame: six months ] [ Designated as safety issue: Yes ]
    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:
  • Blood gas analysis [ Time Frame: Six months ] [ Designated as safety issue: Yes ]
    Blood gas analysis

  • Care givers involvement [ Time Frame: Six months ] [ Designated as safety issue: No ]
    Through a dedicated questionnaire


Biospecimen Retention:   Samples Without DNA

whole blood, tracheobronchial aspirate (TBA)


Enrollment: 247
Study Start Date: January 2002
Estimated Study Completion Date: December 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01285739

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

No publications provided

Responsible Party: Ercole Zanotti, MD, Fondazione Salvatore Maugeri
ClinicalTrials.gov Identifier: NCT01285739     History of Changes
Other Study ID Numbers: MS-12-2010
Study First Received: January 27, 2011
Last Updated: November 10, 2011
Health Authority: Italy: Ethics Committee

Keywords provided by Fondazione Salvatore Maugeri:
Pulmonary Disease, Chronic Obstructive.
Tracheostomy.
Invasive Mechanical Ventilation.
Non-Invasive Mechanical Ventilation.

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2013