Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-25 @ 4:04 AM
NCT ID:
NCT01021202
Brief Summary:
The purpose of this study is:
* to evaluate the optimal time-point for percutaneous dilation tracheostomy in COPD patients in terms of duration on mechanical ventilation, length of stay on ICU and mortality;
* to evaluate the rate of infections and infectious complications of tracheostomized COPD patients;
* to evaluate the spectrum of pathogens in tracheostomized and intubated COPD patients;
* to evaluate the amount of sedatives used in mechanically ventilated COPD patients;
* to assess the quality of life in COPD patients tracheostomized after 3 or after 10 days.
Detailed Description:
Screening of patients following inclusion and exclusion criteria on all units of the Department of Critical Care will occur on a daily basis.
Randomization will be performed by blocks of sealed envelopes containing random numbers which are deposited at a central space within the Department of Critical Care Medicine. Randomization is performed as permuted block randomization.
Collection of baseline parameters (last/current lung function test, last/current 6-min walk test, cardiac stress test - if accessible) If not accessible, current lung function test results (at least FEV1 and FVC) are requested from the patient's general physician or pulmonologist to determine GOLD stage.
Patients randomized into the (early tracheostomy) study group, will undergo tracheostomy at the next possible opportunity but not later than 72 h after initiation of invasive ventilation. Patients of the control group will be invasively ventilated at least until Day 10.
Before tracheostomy a complete endoscopic inspection of the bronchial system will be performed routinely. Bronchoalveolar lavage fluid (BALF) will be obtained from sites of pulmonary infiltrations. In case of no radiographically or bronchoscopic detectable infiltrations BALF will be drawn from the Middle Lobe.
Primary and secondary endpoints will be analyzed at given time-points.
Study:
NCT01021202
Study Brief:
Protocol Section:
NCT01021202