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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

January 27, 2011
November 10, 2011
January 2002
September 2011   (final data collection date for primary outcome measure)
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.
ventilator associated pneumonia (VAP) [ Time Frame: six months ] [ Designated as safety issue: Yes ]
Evidence of clinically definite VAP(ventilator associated pneumonia) confirmed by blood analysis and chest radiography
Complete list of historical versions of study NCT01285739 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
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).

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).

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

whole blood, tracheobronchial aspirate (TBA)

Non-Probability Sample

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.

Chronic Obstructive Pulmonary Disease (COPD)
  • 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
  • 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
  • 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
    Intervention: Other: WBC, biomarkers, TBA, chest X ray
  • 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)
    Intervention: Other: WBC, biomarkers, TBA, chest X ray
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
247
December 2011
September 2011   (final data collection date for primary outcome measure)

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
Both
50 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01285739
MS-12-2010
Yes
Ercole Zanotti, Fondazione Salvatore Maugeri
Fondazione Salvatore Maugeri
Not Provided
Principal Investigator: Ercole Zanotti, MD Fondazione Salvatore Maugeri
Fondazione Salvatore Maugeri
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP