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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01021202
Other study ID # KIM-PV3278/UKE
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date October 2009
Est. completion date April 2014

Study information

Verified date June 2022
Source Universitätsklinikum Hamburg-Eppendorf
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Terminated
Enrollment 23
Est. completion date April 2014
Est. primary completion date April 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Germany Universitätsklinikum Hamburg - Eppendorf (University Medical Center Hamburg-Eppendorf) Hamburg

Sponsors (1)

Lead Sponsor Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cumulative duration of mechanical ventilation (in days) Cumulative duration of mechanical ventilation (in days) Day 1 - 28
Secondary All-cause mortality All-cause mortality Day 28, 90 and end of ICU stay
Secondary Length of stay on ICU / hospital Length of stay on ICU / hospital end of ICU / hospital stay
Secondary Infections (Ventilator-associated pneumonia, spectrum of pathogens in BALF, infectious complications) Infections (Ventilator-associated pneumonia, spectrum of pathogens in BALF, infectious complications) Day 1 - 28
Secondary Cumulative use of sedatives Cumulative use of sedatives Day 1 - 28
Secondary Quality of Life - Questionnaire Quality of Life - Questionnaire discharge from ICU, day 28 and day 90
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