TerminatedNot Applicable

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

Stopped: unexpectedly slow recruitment

Germany23 participantsStarted 2009-10

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cumulative duration of mechanical ventilation (in days)

Timeframe: Day 1 - 28

Trial details

NCT IDNCT01021202

SponsorUniversitätsklinikum Hamburg-Eppendorf

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-04

View on ClinicalTrials.gov More Pulmonary Disease, Chronic Obstructive trials