Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
tracheostomy, tracheotomy, dilational, dilatative, critical care, intensive care, COPD, chronic obstructive pulmonary disease, lung disease, pneumonia, prospective study, questionnaire, quality of life, outcome, mortality
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.
Interventions
PROCEDUREPercutaneous dilation tracheostomy
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.
Sponsors
Universitätsklinikum Hamburg-Eppendorf
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of COPD (GOLD stage III or IV) * Suspected long-time invasive mechanical ventilation due to ARF (\> 10 days) * Informed consent of the patient or legal guardian
Exclusion criteria
* Severe neurological failure (such as stroke, cerebral haemorrhage etc.) * Immunosuppressant therapy (with the exception of steroid therapy) * Major risk of bleeding * Intubation \> 72 h * Contraindication for dilation tracheotomy * Impossibility of intubation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative duration of mechanical ventilation (in days) | Day 1 - 28 | Cumulative duration of mechanical ventilation (in days) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of stay on ICU / hospital | end of ICU / hospital stay | Length of stay on ICU / hospital |
| All-cause mortality | Day 28, 90 and end of ICU stay | All-cause mortality |
| Infections (Ventilator-associated pneumonia, spectrum of pathogens in BALF, infectious complications) | Day 1 - 28 | Infections (Ventilator-associated pneumonia, spectrum of pathogens in BALF, infectious complications) |
| Cumulative use of sedatives | Day 1 - 28 | Cumulative use of sedatives |
| Quality of Life - Questionnaire | discharge from ICU, day 28 and day 90 | Quality of Life - Questionnaire |
Countries
Germany
Outcome results
None listed