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

NCT ID: NCT01021202

Last Updated: 2022-07-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2014-04-30

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Early tracheostomy

Percutaneous dilation tracheostomy \< 72h on mechanical ventilation

Group Type: EXPERIMENTAL

Percutaneous dilation tracheostomy

Intervention Type: 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.

Late tracheostomy

Percutaneous dilation tracheostomy \> 10 days on mechanical ventilation

Group Type: EXPERIMENTAL

Percutaneous dilation tracheostomy

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stefan Kluge, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Hamburg, , Germany

Countries

Germany

Other Identifiers

KIM-PV3278/UKE

Identifier Type: -

Identifier Source: org_study_id