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Tracheostomized COPD Patients and Non Invasive Mechanical Ventilation

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01285739
Enrollment
247
Registered
2011-01-28
Start date
2002-01-31
Completion date
2011-12-31
Last updated
2011-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

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

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).

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).

Interventions

OTHERWBC, biomarkers, TBA, chest X ray

The above cited parameters were recorded and investigated every six months; chest X ray when needed.

Sponsors

Fondazione Salvatore Maugeri
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
ventilator associated pneumonia (VAP)six monthsVAP 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

MeasureTime frameDescription
Blood gas analysisSix monthsBlood gas analysis
Care givers involvementSix monthsThrough a dedicated questionnaire

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026