Trial document





This trial has been registered retrospectively.
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  DRKS00004696

Trial Description

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Title

Prospective study on breathing synchronized electrical stimulation of the abdominal muscles in patients with acute and chronic tetraplegia

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Trial Acronym

AbdomenStim

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URL of the Trial

http://www.abdomenstim.de

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Brief Summary in Lay Language

Central problem in the care of patients with acute paralysis of the cervical cord is the long-term prevention of complications in the lungs (pneumonia). By the injury, the ability to breathe and cough worse.
A preliminary study (proof of concept), we want to check if a breath-dependent stimulation of the abdominal muscles leads to better breathing and coughing, and thus reduced the number of lung infections. In the study we are using electricity stimulate the abdominal muscles when you exhale, so that they contract. Breathing out, we measure directly the ventilators or by an additional mask over his face. We begin with this therapy as soon as possible after the accident so that your muscles do not usually reverses. The stimulation is done twice a day for 30 minutes over a period of 90 days. The aim is to look to improve if the number of lung inflammation and other respiratory parameters.

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Brief Summary in Scientific Language

Central problem in the care of patients with paralysis of the throat and upper chest Marks is to secure the airway and the long-term prevention of complications such as pneumonia.
The objective of the proposed research project is to reduce the number of complications in the primary steady progress after the accident. This with the help of an electrical stimulation of the abdominal muscles to the expiration and the cough . The respiration is measured on the respiratory ventilator or by means of a face mask. The stimulation is applied for 30 minutes twice a day over a period of 90 days. Endpoint of the study is the number of pneumonia. The study design provided 14 patients is examined, 9 should stay beyond the period of stimulation without pneumonia.

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Organizational Data

  •   DRKS00004696
  •   2013/03/01
  •   [---]*
  •   yes
  •   Approved
  •   EA1/211/10, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   G80.0 -  Spastic quadriplegic cerebral palsy
  •   J18.0 -  Bronchopneumonia, unspecified
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Interventions/Observational Groups

  •   Breathing synchronized electrical stimulation of the abdominal muscles. The stimulation is applied for 30 minutes twice a day over a period of 90 days.
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Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Prevention
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Pneumonia rate over the period of abdominal stimulation (90 days)

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Secondary Outcome

mortality, days in hospital, weaning, period of ventilation

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2011/11/30
  •   14
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
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Additional Inclusion Criteria

Men and women
SCI paralysis C4 - Th3
Paralysis not older than 4 weeks, with no extubation, the period is due to the treatment of the underlying disease.
BMI <35
Age 18 - 80 years
Intensive monitoring obligation
Mandatory ventilation at baseline
Consent by the patient

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Exclusion Criteria

lack of consent
pulmonary disease (COPD)
progressive Disease
impossibility to place electrodes abdominal
pregnancy
pacemaker or similar implants interfere with the electrical stimulation

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Unfallkrankenhaus Berlin
    • Mr.  PD Dr. med.  Rainer  Seidl 
    • Warenerstrasse 7
    • 12683  Berlin
    • Germany
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    • Unfallkrankenhaus Berlin
    • Mr.  PD Dr. med.  Rainer  Seidl 
    • Warenerstrasse 7
    • 12683  Berlin
    • Germany
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    • Unfallkrankenhaus Berlin
    • Mr.  Dr. med.  Andreas  Niedeggen 
    • Warnerstrasse 7
    • 12683  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • DGUV – Forschungsförderung
    • Alte Heerstasse 111
    • 53757  St. Augustin
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting stopped after recruiting started
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.