Trial document




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  DRKS00009397

Trial Description

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Title

Weaning in patients after determination of invasive home mechanical ventilation:
What is possible in a specialised weaning unit?

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The number of patients in Germany on invasive home mechanical ventilation (=mechanical ventilation in an outpatient setting via a tube, which is directly situated in the trachea) jumped up in the last ten years; nevertheless accurate epidemiological numbers are missing.
The problem is, that a majority of patients have not been finally evaluated for weaning potential in a specialised certified weaning unit.
Those patients are rather discharged to home mechanical ventilation directly from the intensive care unit, without weaning being evaluated in a specialized weaning unit.
This leads to two major problems:
1. Occasionally patients are on invasive home mechanical ventilation, although weaning would have been successful. This leads to significant limitation of quality of life and unnecessary intervention in the social life of the patients. Also studies regarding the quality of life of patients on invasive home mechanical ventilation after failure of prolonged weaning show that a considerable part of the patient has a low quality of life. Missing a successful weaning can therefore be of great disadvantage for the individual patient.
2. On the other hand it has to be assumed that there will be an explosion of costs. Although an inpatient treatment in a specialized weaning unit does also produce costs, the saving potential has to be classified as highly significant even if only a part of the patients, who were already assigned to invasive home mechanical ventilation without being evaluated for weaning potential in a specialized weaning unit, can be weaned.

Aim of this study is to evaluate the weaning potential of patients who were transferred to home mechanical ventilation by bypassing specialized and certified weaning units. The question is how high is the percentage of patients, who can eventually be weaned from invasive ventilation because of the expertise in a specialized weaning unit. The control group will include patients who were discharged in home mechanical ventilation without a stay in a specialized weaning unit. The costs for the inpatient treatment in a weaning unit will be contrasted to the potential savings due to termination of invasive ventilation, respectively.

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Brief Summary in Scientific Language

The number of patients in Germany on invasive home mechanical ventilation jumped up in the last ten years; nevertheless accurate epidemiological numbers are missing.
The problem is, that a majority of patients have not been finally evaluated for weaning potential in a specialised certified weaning unit.
Those patients are rather discharged to home mechanical ventilation directly from the intensive care unit, without weaning being evaluated in a specialized weaning unit.
This leads to two major problems:
1. Occasionally patients are on invasive home mechanical ventilation, although weaning would have been successful. This leads to significant limitation of quality of life and unnecessary intervention in the social life of the patients. Also studies regarding the quality of life of patients on invasive home mechanical ventilation after failure of prolonged weaning show that a considerable part of the patient has a low quality of life. Missing a successful weaning can therefore be of great disadvantage for the individual patient.
2. On the other hand it has to be assumed that there will be an explosion of costs. Although an inpatient treatment in a specialized weaning unit does also produce costs, the saving potential has to be classified as highly significant even if only a part of the patients, who were already assigned to invasive home mechanical ventilation without being evaluated for weaning potential in a specialized weaning unit, can be weaned.

Aim of this study is to evaluate the weaning potential of patients who were transferred to home mechanical ventilation by bypassing specialized and certified weaning units. The question is how high is the percentage of patients, who can eventually be weaned from invasive ventilation because of the expertise in a specialized weaning unit. The control group will include patients who were discharged in home mechanical ventilation without a stay in a specialized weaning unit. The costs for the inpatient treatment in a weaning unit will be contrasted to the potential savings due to termination of invasive ventilation, respectively.

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Organizational Data

  •   DRKS00009397
  •   2015/10/02
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  •   yes
  •   Approved
  •   48/2015, Ethik-Kommission der Universität Witten/Herdecke
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Secondary IDs

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Health Condition or Problem studied

  •   Weaning category 3 (prolonged weaning) c (unsuccessfull weaning with the need of invasive home mechanical ventilation)
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Interventions/Observational Groups

  •   Patients who are invasively ventilated in an outpatient setting, but have not been transferred to invasive home mechanical ventilation by a specialized and certified weaning unit. Only those patients will be included who are transferred to a specialized weaning unit to especially check for weaning potential and who are on home mechanical ventilation for nor more than 90 days. Patients who are transferred to the weaning unit on a regular control visit will not be included. Patients who have been discharged by a certified weaning unit before cannot be included.
  •   Patients who are planned to be dischared by an inpatient ventilatory unit (which is not associated to a specialized weaning unit) where the process of discharge to a home mechanical ventilation setting has been started. Weaning has to be terminated and has to be classified as “not successful”. Patients who are still ongoing weaning cannot be included. The transferring clinic has to confirm in written form that weaning is terminated in their clinic and that is has been unsuccessful.
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Control group receives no treatment
  •   Health care system
  •   Other
  •   IV
  •   N/A
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Primary Outcome

weaning rate (dichotomous) at discharge from weaning unit

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Secondary Outcome

- projected cost savings regarding inasive home mechanical ventilation for a period of 6 to 12 months
- rate of complications and death rate during the stay in the weaning unit
- health related quality of life

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/10/15
  •   128
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
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Additional Inclusion Criteria

1.1. Patients invasively ventilated in an outpatient setting, but have not been transferred to invasive home mechanical ventilation by a specialized and certified weaning unit
1.2. Patients who are transferred to a specialized weaning unit to especially check for weaning potential
1.3. on home mechanical ventilation for not more than 90 days
2.1. Patients who are planned to be dischared by an inpatient ventilatory unit (which is not associated to a specialized weaning unit) in which the process of discharge to a home mechanical ventilation setting has been started. Weaning has to be terminated and has to be classified as “not successful”. The transferring clinic has to confirm in written form that weaning is terminated in their clinic and that is has been unsuccessful.

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Exclusion Criteria

1. Patients who are reffered to the weaning unit to reevaluate invasive ventilation
2. Patients who were treated in a speciallized weaning unit before
3. Patients in a running weaning process

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Addresses

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    • Lungenklinik Köln-MerheimKliniken der Stadt Köln gGmbH
    • Mr.  Prof. Dr. med.  Wolfram  Windisch 
    • Ostmerheimer Strasse 200
    • 51109  Köln
    • Germany
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    • Thoraxklinik-Heidelberg gGmbH
    • Mr.  Prof. Dr. med.  Felix  Herth 
    • Amalienstr. 5
    • 69126  Heidelberg
    • Germany
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    • Asklepios FachklinikenKlinik für Intensivmedizin, Schlaf- und Beatmungsmedizin
    • Mr.  Dr. med.  Jens G.  Geiseler 
    • Robert-Koch-Allee 2
    • 82131  Gauting
    • Germany
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    • Klinik Donaustauf
    • Mr.  Prof. Dr.  Michael  Pfeifer 
    • Ludwigstr. 68
    • 93093  Donaustauf
    • Germany
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    • Ruhrlandklinik, Westdeutsches Lungenzentrum, Universitätsklinikum Essen
    • Mr.  Prof. Dr.  Hemut  Teschler 
    • Tüschener Weg 40
    • 45239  Essen
    • Germany
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    • Lungenklinic Grosshansdorf
    • Mr.  Prof. Dr.  Klaus  Rabe 
    • Wöhrendamm 80
    • 22927  Großhansdorf
    • Germany
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    • Universitätsklinik Greifswald, Bereich Pneumologie und Infektiologie der Klinik für Innere Medizin B
    • Mr.  Prof. Dr.  Ralf  Ewert 
    • Ferdinand-Sauerbruch-Straße
    • 17475  Greifswald
    • Germany
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    • Lungenklinik Köln-MerheimKliniken der Stadt Köln gGmbH
    • Mr.  Prof. Dr. med.  Wolfram  Windisch 
    • Ostmerheimer Strasse 200
    • 51109  Köln
    • Germany
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    end of 1:1-Block address contact scientific-contact
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    • Lungenklinik Köln-MerheimKliniken der Stadt Köln gGmbH
    • Mr.  Prof. Dr. med.  Wolfram  Windisch 
    • Ostmerheimer Strasse 200
    • 51109  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Gesundheit (BMG)
    • Rochusstraße 1
    • 53123  Bonn
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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