MedDataX Logo

Tracheostomized COPD Patients and Non Invasive Mechanical Ventilation

NCT ID: NCT01285739

Last Updated: 2011-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

247 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-01-31

Study Completion Date

2011-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Obstructive Pulmonary Disease (COPD)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

WBC, biomarkers, TBA, chest X ray

Intervention Type OTHER

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

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)

WBC, biomarkers, TBA, chest X ray

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

WBC, biomarkers, TBA, chest X ray

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

Intervention Type OTHER

WBC, biomarkers, TBA, chest X ray

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

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

PCT; CRP PCT; CPR

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fondazione Salvatore Maugeri

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ercole Zanotti

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ercole Zanotti, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione Salvatore Maugeri

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Weaning Center - Fondazione Salvatore Maugeri IRCCS

Montescano, Pavia, Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MS-12-2010

Identifier Type: -

Identifier Source: org_study_id