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

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ClinicalTrials.gov Identifier: NCT01021202
Recruitment Status : Suspended (unexpectedly slow recruitment)
First Posted : November 26, 2009
Last Update Posted : July 16, 2015
Sponsor:
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf

Tracking Information
First Submitted Date  ICMJE October 6, 2009
First Posted Date  ICMJE November 26, 2009
Last Update Posted Date July 16, 2015
Study Start Date  ICMJE October 2009
Estimated Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 25, 2009)
Cumulative duration of mechanical ventilation (in days) [ Time Frame: Day 1 - 28 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01021202 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 25, 2009)
  • All-cause mortality [ Time Frame: Day 28, 90 and end of ICU stay ]
  • Length of stay on ICU / hospital [ Time Frame: end of ICU / hospital stay ]
  • Infections (Ventilator-associated pneumonia, spectrum of pathogens in BALF, infectious complications) [ Time Frame: Day 1 - 28 ]
  • Cumulative use of sedatives [ Time Frame: Day 1 - 28 ]
  • Quality of Life [ Time Frame: discharge from ICU, day 28 and day 90 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Timing of Dilation Tracheostomy in Mechanically Ventilated Chronic Obstructive Pulmonary Disease (COPD) Patients
Official Title  ICMJE Early vs. Late Percutaneous Dilation Tracheostomy in Mechanically Ventilated Patients With Chronic Obstructive Pulmonary Disease
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Pulmonary Disease, Chronic Obstructive
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Early tracheostomy
    Percutaneous dilation tracheostomy < 72h on mechanical ventilation
    Intervention: Procedure: Percutaneous dilation tracheostomy
  • Experimental: Late tracheostomy
    Percutaneous dilation tracheostomy > 10 days on mechanical ventilation
    Intervention: Procedure: Percutaneous dilation tracheostomy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: November 25, 2009)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2017
Estimated Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01021202
Other Study ID Numbers  ICMJE KIM-PV3278/UKE
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Universitätsklinikum Hamburg-Eppendorf
Study Sponsor  ICMJE Universitätsklinikum Hamburg-Eppendorf
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Stefan Kluge, MD Department of Critical Care Medicine, University Medical Center Hamburg - Eppendorf
PRS Account Universitätsklinikum Hamburg-Eppendorf
Verification Date July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP