Tracheostomized COPD Patients and Non Invasive Mechanical Ventilation
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ClinicalTrials.gov Identifier: NCT01285739 |
Recruitment Status
: Unknown
Verified December 2010 by Ercole Zanotti, Fondazione Salvatore Maugeri.
Recruitment status was: Active, not recruiting
First Posted
: January 28, 2011
Last Update Posted
: November 11, 2011
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Condition or disease | Intervention/treatment |
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Chronic Obstructive Pulmonary Disease (COPD) | Other: WBC, biomarkers, TBA, chest X ray |
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 |
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
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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
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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)
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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
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- 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.
- Blood gas analysis [ Time Frame: Six months ]Blood gas analysis
- Care givers involvement [ Time Frame: Six months ]Through a dedicated questionnaire
Biospecimen Retention: Samples Without DNA

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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 |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01285739
Italy | |
Weaning Center - Fondazione Salvatore Maugeri IRCCS | |
Montescano, Pavia, Italy, 27040 |
Principal Investigator: | Ercole Zanotti, MD | Fondazione Salvatore Maugeri |
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 Key Record Dates |
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 |