An interventional study of Percutaneous dilation tracheostomy in Pulmonary Disease, Chronic Obstructive, sponsored by Universitätsklinikum Hamburg-Eppendorf. Terminated at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-01.
Sponsored by Universitätsklinikum Hamburg-Eppendorf · Not applicable, Interventional, and Supportive care
The purpose of this study is:
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.
4,252 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 707 are open to participants now.
This study's enrollment of 23 is below the median of 70 across 3,008 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Universitätsklinikum Hamburg-Eppendorf is the lead sponsor of 415 studies on the registry; 85 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Percutaneous dilation tracheostomy \< 72h on mechanical ventilation
Procedure: Percutaneous dilation tracheostomy
Percutaneous dilation tracheostomy \> 10 days on mechanical ventilation
Procedure: Percutaneous 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.
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
Ran from Oct 2009 to primary completion in Apr 2014, 54 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Pulmonary Disease, Chronic Obstructive →
Universitätsklinikum Hamburg-Eppendorf →