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:

MedlinePlus related topics: COPD Lung Diseases X-Rays

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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


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 Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 23, 2016

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