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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Universitätsklinikum Hamburg-Eppendorf.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT01021202
First received: October 6, 2009
Last updated: January 11, 2011
Last verified: January 2011
  Purpose

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.

Condition Intervention
Pulmonary Disease, Chronic Obstructive
Procedure: Percutaneous dilation tracheostomy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Early vs. Late Percutaneous Dilation Tracheostomy in Mechanically Ventilated Patients With Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:


Further study details as provided by Universitätsklinikum Hamburg-Eppendorf:

Primary Outcome Measures:
  • Cumulative duration of mechanical ventilation (in days) [ Time Frame: Day 1 - 28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • All-cause mortality [ Time Frame: Day 28, 90 and end of ICU stay ] [ Designated as safety issue: No ]
  • Length of stay on ICU / hospital [ Time Frame: end of ICU / hospital stay ] [ Designated as safety issue: No ]
  • Infections (Ventilator-associated pneumonia, spectrum of pathogens in BALF, infectious complications) [ Time Frame: Day 1 - 28 ] [ Designated as safety issue: No ]
  • Cumulative use of sedatives [ Time Frame: Day 1 - 28 ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: discharge from ICU, day 28 and day 90 ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: October 2009
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Early 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.
Late 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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01021202

Contacts
Contact: Stefan Kluge, MD +4940 7410 ext 57010 s.kluge@uke.de
Contact: Jan K Hennigs, MD +4940 7410 ext 35400 j.hennigs@uke.de

Locations
Germany
Universitätsklinikum Hamburg - Eppendorf (University Medical Center Hamburg-Eppendorf) Recruiting
Hamburg, Germany, 20246
Contact: Stefan Kluge, MD    +4940 7410 ext 57010    s.kluge@uke.de   
Principal Investigator: Stefan Kluge, MD         
Sub-Investigator: Jan K Hennigs, MD         
Sub-Investigator: Hans Jörg Baumann, MD         
Sub-Investigator: Hans Klose, MD         
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Investigators
Principal Investigator: Stefan Kluge, MD Department of Critical Care Medicine, University Medical Center Hamburg - Eppendorf
  More Information

No publications provided

Responsible Party: Dr. Stefan Kluge, MD, Department of Critical Care Medicine
ClinicalTrials.gov Identifier: NCT01021202     History of Changes
Other Study ID Numbers: KIM-PV3278/UKE
Study First Received: October 6, 2009
Last Updated: January 11, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
chronic obstructive pulmonary disease
tracheostomy
tracheotomy
dilational
dilatative
critical care
intensive care
COPD
lung disease
pneumonia
prospective study
questionnaire
quality of life
outcome
mortality

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 20, 2014