Trial document




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  DRKS00004865

Trial Description

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Title

The impact of different humidification techniques in newly tracheotomized patients - an ex vivo study

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Trial Acronym

high flow airway humidification (Airvo)

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The purpose of this study is to evaluate the impact of different airway humidification techniques on the function of tracheal mucosa cells in patients who have undergone tracheotomy, which is an artificial opening into the trachea. Both, female and male patients aged eighteen or older and facing a planned tracheotomy within the context of the treatment of underlying conditions may be included in the study. After a tracheotomy, the nose is no longer able to perform its air humidification and warming function. To minimize complications after a tracheotomy, the most established technique is to use cold air humidification, by holding a mask in front of the tracheostoma. By using this method, problems that can occur after tracheotomy like infections, inflammations or the clogging of trachea can be minimized. However, to this day the clinical superiority of the high flow airway humidification systems’ effect on the ciliary beat function has not been proved.

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Brief Summary in Scientific Language

For newly tracheotomized patients, several different possibilities of airway humidification exist. To minimize respiratory complications, the method most established is the cold air humidification, using an uphold mask in front of the tracheostoma. As there is no air warming, effects on the ciliary function can be suspected. High flow air warming systems like the Fisher & Paykel Healthcare “Airvo” are said to compensate this disadvantage. To this day, the clinical superiority of these high flow air warming systems in relation to the ciliary function has not been reviewed or verified. Since the ciliated cells are vital for a limited time even post extraction, the influence of such humidification systems may be examined by ex-vivo analysis without causing any discomfort to the patient. Therefore, tracheal mucosa brush cytology of ciliary carrying cells is taken via the tracheostoma and is transferred into the nutrient medium. Beating cilia may then be visualized using phase contrast microscopy with an attached high-speed digital camera. Furthermore, the necessary interventions at the tracheostma – like suctions, the number of tracheitis, as well as the subjective evaluation of afflictions – are detected by using counting lists and evaluation lists, as well as a questionnaire.

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Organizational Data

  •   DRKS00004865
  •   2013/06/04
  •   [---]*
  •   yes
  •   Approved
  •   2013-402M-MA, Medizinische Ethik-Kommission II Medizinische Fakultät Mannheim der Universität Heidelberg
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Secondary IDs

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Health Condition or Problem studied

  •   Z93.0 -  Tracheostomy status
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Interventions/Observational Groups

  •   Provisioning of cold air humidification system to the newly tracheotomized patient.
  •   Provisioning of high-flow warm air humidification system to the newly tracheotomized patient.
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Ciliary function, measured using videodocumented ciliary beat frequency and a so called visual integrity index (VI) of tracheal epithelial cells harvested at day 1, 3, 5, 7,9,11,13 after tracheotomy.

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Secondary Outcome

daily episodes of medical intervention at the tracheostoma / trachea because of respiratory / tracheal complaints.
Number of required tracheostoma suctions because of excessive mucus.
Frequency of tracheitis.
Subjective complaints in terms of a questionnaire assessing respiratory / lower airway function.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2013/06/01
  •   20
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Any therapy which includes a planned tracheotomy.

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Exclusion Criteria

no consent regarding participation, known ciliary dysfunction, patients with tracheostoma in past medical history

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Addresses

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    • Universitätsklinikum Mannheim
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
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    • Univ.-HNO-Klinik Mannheim
    • Mr.  Dr. med.  J. Ulrich  Sommer 
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
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    • Univ.-HNO-Klinik Mannheim
    • Mr.  Dr. med.  J. Ulrich  Sommer 
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
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Sources of Monetary or Material Support

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    • Fisher & Paykel Healthcare
    • 15 Maurice Paykel Pl
    • 2013  East Tamaki
    • New Zealand
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    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2017/05/30
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Trial Publications, Results and other Documents

  •   2017 Head & Neck; Heated air humidification versus cold air nebulization in newly tracheostomized patients; Richard Birk, Alexander Händel, Angela Wenzel, Benedikt Kramer Christoph Aderhold Karl Hörmann Boris A. Stuck J. Ulrich Sommer
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* This entry means the parameter is not applicable or has not been set.