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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
23
Percutaneous dilation tracheostomy using Ciaglia blue rhino system (Cook medical, Limerick, IRELAND). Tracheostomy is conducted by two experienced physicians with (video-)bronchoscopic control and continuous monitoring of ECG, blood pressure, pulse and peripheral oxygen saturation.
Universitätsklinikum Hamburg - Eppendorf (University Medical Center Hamburg-Eppendorf)
Hamburg, Germany
Cumulative duration of mechanical ventilation (in days)
Cumulative duration of mechanical ventilation (in days)
Time frame: Day 1 - 28
All-cause mortality
All-cause mortality
Time frame: Day 28, 90 and end of ICU stay
Length of stay on ICU / hospital
Length of stay on ICU / hospital
Time frame: end of ICU / hospital stay
Infections (Ventilator-associated pneumonia, spectrum of pathogens in BALF, infectious complications)
Infections (Ventilator-associated pneumonia, spectrum of pathogens in BALF, infectious complications)
Time frame: Day 1 - 28
Cumulative use of sedatives
Cumulative use of sedatives
Time frame: Day 1 - 28
Quality of Life - Questionnaire
Quality of Life - Questionnaire
Time frame: discharge from ICU, day 28 and day 90
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