Timing of Dilation Tracheostomy in Mechanically Ventilated Chronic Obstructive Pulmonary Disease (COPD) Patients

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

Early vs. Late Percutaneous Dilation Tracheostomy in Mechanically Ventilated Patients With Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01021202
• Other study ID #: KIM-PV3278/UKE
• Status: Terminated
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

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