Timing of Dilation Tracheostomy in Mechanically Ventilated Chronic Obstructive Pulmonary Disease (COPD) Patients
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Interventions
- Procedure: Percutaneous dilation tracheostomy
- Registration Number
- NCT01021202
- Lead Sponsor
- Universitätsklinikum Hamburg-Eppendorf
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 23
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Early tracheostomy Percutaneous dilation tracheostomy Percutaneous dilation tracheostomy \< 72h on mechanical ventilation Late tracheostomy Percutaneous dilation tracheostomy Percutaneous dilation tracheostomy \> 10 days on mechanical ventilation
- Primary Outcome Measures
Name Time Method Cumulative duration of mechanical ventilation (in days) Day 1 - 28 Cumulative duration of mechanical ventilation (in days)
- Secondary Outcome Measures
Name Time Method All-cause mortality Day 28, 90 and end of ICU stay All-cause mortality
Cumulative use of sedatives Day 1 - 28 Cumulative use of sedatives
Length of stay on ICU / hospital end of ICU / hospital stay Length of stay on ICU / hospital
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)
Quality of Life - Questionnaire discharge from ICU, day 28 and day 90 Quality of Life - Questionnaire
Trial Locations
- Locations (1)
Universitätsklinikum Hamburg - Eppendorf (University Medical Center Hamburg-Eppendorf)
🇩🇪Hamburg, Germany