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

NCT01021202 | Terminated

• 1 other identifier: KIM-PV3278/UKE
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Cumulative duration of mechanical ventilation (in days)

  Cumulative duration of mechanical ventilation (in days)

  Day 1 - 28

Secondary Outcomes (5)

• All-cause mortality

  Day 28, 90 and end of ICU stay

• Length of stay on ICU / hospital

  end of ICU / hospital stay

• Infections (Ventilator-associated pneumonia, spectrum of pathogens in BALF, infectious complications)

  Day 1 - 28

• Cumulative use of sedatives

  Day 1 - 28

• Quality of Life - Questionnaire

  discharge from ICU, day 28 and day 90

Study Arms (2)

Early tracheostomy

EXPERIMENTAL

Percutaneous dilation tracheostomy \< 72h on mechanical ventilation

Procedure: Percutaneous dilation tracheostomy

Late tracheostomy

EXPERIMENTAL

Percutaneous dilation tracheostomy \> 10 days on mechanical ventilation

Procedure: Percutaneous dilation tracheostomy

Interventions

Percutaneous dilation tracheostomy PROCEDURE

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.

Early tracheostomy; Late tracheostomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

Universitätsklinikum Hamburg - Eppendorf (University Medical Center Hamburg-Eppendorf)

Hamburg, 20246, Germany

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Lung Diseases; Pneumonia

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Tract Infections; Infections

Study Officials

• Stefan Kluge, MD

  Department of Critical Care Medicine, University Medical Center Hamburg - Eppendorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2009
• First Posted: November 26, 2009
• Study Start: October 1, 2009
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: July 1, 2022

Record last verified: 2022-06

Locations

DE (1)