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

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

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.

Study Overview

• Status: Terminated
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Procedure: Percutaneous dilation tracheostomy

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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 20246
    • Universitätsklinikum Hamburg - Eppendorf (University Medical Center Hamburg-Eppendorf)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early tracheostomy; Percutaneous dilation tracheostomy < 72h 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.
Experimental: Late 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative duration of mechanical ventilation (in days)	Cumulative duration of mechanical ventilation (in days)	Day 1 - 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	All-cause mortality	Day 28, 90 and end of ICU stay
Length of stay on ICU / hospital	Length of stay on ICU / hospital	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)	Day 1 - 28
Cumulative use of sedatives	Cumulative use of sedatives	Day 1 - 28
Quality of Life - Questionnaire	Quality of Life - Questionnaire	discharge from ICU, day 28 and day 90

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Investigators: Principal Investigator: Stefan Kluge, MD, Department of Critical Care Medicine, University Medical Center Hamburg - Eppendorf

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2009
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: October 6, 2009
• First Submitted That Met QC Criteria: November 25, 2009
• First Posted (Estimate): November 26, 2009

Study Record Updates

• Last Update Posted (Actual): July 1, 2022
• Last Update Submitted That Met QC Criteria: June 29, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: critical care; quality of life; COPD; outcome; intensive care; pneumonia; mortality; questionnaire; lung disease; tracheotomy; chronic obstructive pulmonary disease; prospective study; tracheostomy; dilational; dilatative
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: KIM-PV3278/UKE