Clinical trial NCT01021202: Timing of Dilation Tracheostomy in Mechanically Ventilated Chronic Obstructive Pulmonary Disease (COPD) Patients
Official title: Early vs. Late Percutaneous Dilation Tracheostomy in Mechanically Ventilated Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
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
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2009-11-26
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cumulative duration of mechanical ventilation (in days)
timeFrame: Day 1 - 28
Secondary outcomes:
measure: All-cause mortality
timeFrame: Day 28, 90 and end of ICU stay
measure: Length of stay on ICU / hospital
timeFrame: end of ICU / hospital stay
measure: Infections (Ventilator-associated pneumonia, spectrum of pathogens in BALF, infectious complications)
timeFrame: Day 1 - 28
measure: Cumulative use of sedatives
timeFrame: Day 1 - 28
measure: Quality of Life - Questionnaire
timeFrame: discharge from ICU, day 28 and day 90
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg - Eppendorf (University Medical Center Hamburg-Eppendorf)
Study officials:
affiliation: Department of Critical Care Medicine, University Medical Center Hamburg - Eppendorf
name: Stefan Kluge, MD
role: PRINCIPAL_INVESTIGATOR
References: