Trial document




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  DRKS00000384

Trial Description

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Title

Multicentre trial on long term rehabilitation using HME-filters after a total laryngectomy

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Trial Acronym

HME-Filter Langzeit ReHa

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URL of the Trial

[---]*

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Brief Summary in Lay Language

This trial will analyze whether the strict use of HME-filters (heat and moisture exchangers / artificial nose) in patients more than six months after complete laryngectomy (removal of the larynx) is able to improve patient care in comparison to the standard treatment using external nebulizers.

Included will be patients after a complete laryngectmoy more than six months ago.

As a result of the surgery, the airways from the mouth, nose, and esophagus are separated. The laryngectomee breathes through an opening in the neck, a stoma. Thus the moisturizing and warming effect of the nose on the inhaled air is abolished and the air breathed in through the stoma is colder and drier than usual, potentially leading to irritations of the mucosa of the trachea or bronchii. This might result in enhanced mucus production, incrustations, coughing attacks and possibly to a reduced lung function.

Pilot trials showed a temperature increase of 9°C and a moisture rise of 20% with respect to the inhaled air breathed through an HME-filter in comparison to breathing through the open tracheostoma.

This impovement of the inhaled air might result in an improved lung function. Significant changes of lung function parameters become obvious within the first week after surgery. Symptoms like increased mucus production and a higher frequency of caoughing attacks already start at day one or two after surgery.

Nevertheless, preliminary results hint at an improvement in patinets well-being also if HME-filter use does not start directly after the surgery, but later. The filter use potentially results in a reduction of mucus production and cough frequency as well as an improvement in phonation.

Dircetly befor the laryngectomy, patients participating in this clinical trial will be randomly assigned to a treatment group (HME-filter use versus external nebulizers without HME-filters). During their in hospital stay of 10 days, the patients will be treated according to the randomization result and bronchio pulmonary symptoms (frequency of aspiration, frequency of coughing attacks, mucus production) will be recorded in patient diaries. Additionally, objective parameters of lung function will be determined using lung function tests.

The occurence of bronchio-pulmonary symptoms and the lung function test results compared between the treatment groups will be used to answer the question, whether the moisturizing and warming effect of the HME-filter is able to improve bronchio-pulmonary function in comparison to the standard treatment using external nebulizers.

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Brief Summary in Scientific Language

This trial will analyze whether the strict use of HME-filters (heat and moisture exchangers / artificial nose) in patients directly after complete laryngectomy (removal of the larynx) is able to improve patient care in the immediate post operative phase in comparison to the standard treatment using external nebulizers.

Included will be patients after a complete laryngectmoy in the immediate post operative phase.

As a result of the surgery, the airways from the mouth, nose, and esophagus are separated. The laryngectomee breathes through an opening in the neck, a stoma. Thus the moisturizing and warming effect of the nose on the inhaled air is abolished and the air breathed in through the stoma is colder and drier than usual, potentially leading to irritations of the mucosa of the trachea or bronchii. This might result in enhanced mucus production, incrustations, coughing attacks and possibly to a reduced lung function.

Pilot trials showed a temperature increase of 9°C and a moisture rise of 20% with respect to the inhaled air breathed through an HME-filter in comparison to breathing through the open tracheostoma.

This impovement of the inhaled air might result in an improved lung function.

Dircetly befor the laryngectomy, patients participating in this clinical trial will be randomly assigned to a treatment group (HME-filter use versus external nebulizers without HME-filters). During their in hospital stay of 10 days, the patients will be treated according to the randomization result and bronchio pulmonary symptoms (frequency of aspiration, frequency of coughing attacks, mucus production) will be recorded in patient diaries. Additionally, objective parameters of lung function will be determined using lung function tests.

The occurence of bronchio-pulmonary symptoms and the lung function test results compared between the treatment groups will be used to answer the question, whether the moisturizing and warming effect of the HME-filter is able to improve bronchio-pulmonary function in comparison to the standard treatment using external nebulizers.

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Organizational Data

  •   DRKS00000384
  •   2010/03/25
  •   [---]*
  •   yes
  •   Approved
  •   256/09, Ethik-Kommission der Universität Ulm
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Secondary IDs

  •   U1111-1114-5157 
  •   HME-Filter Langzeit ReHa  (Bezeichnung des Auftraggebers)
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Health Condition or Problem studied

  •   Z93.0 -  Tracheostomy status
  •   [---]* -  [---]*
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Interventions/Observational Groups

  •   At the day of randomisation the patients will be supplied with HME-Filters, which shall be used continuously until the end of trial after six months. The filter will be changed by the patient regularly.

    The filters used will be from Atos Medical GmbH: PROVOX XtraHME.
  •   The patients will be treated by standard care procedures using external nebulizers.

    This treatment arm does not receive a trial specific therapy. The only additional effort is the data-keeping.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control
  •   Treatment
  •   Parallel
  •   N/A
  •   [---]*
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Primary Outcome

Number of coughing attacks within one week at the time point six months after randomization - determined by the patient's diary.

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Secondary Outcome

Frequency of coughing attacks three months after randomisation as documented in the patients diary for the week before visit T3 || Bronchial mucus production three and six months after randomisation according to the documented number of forced coughing up in the patient's diary for the week before the visit. || Lung function three and six months after randomisation.

Determined will be vital capacity, FEV1 and FIV1, PEF and PIF, MEF50 and MIF50 and total lung capacity (TLC) resulting from a lung function test. || Quality of life three and six months after randomisation, evaluated by patient questionnaires filled in at the visits after three and six months respectively. || Occurence of tracheitis within the trial period of six months

Assessment by bacterial swab tests of the throat at the trial visits || Interrelation between respiratory distress symptoms (coughing, mucus production, shortness of breath) and overall symptoms (tiredness, sleep disorders, anxieties, depression)

Combined analysis of the different questionnaires and diaries over the course of the trial. || Cost effectiveness of the different treatment arms, determined by the documented use of expendable items during trial implementation documented in the patient's diary.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Planned
  •   2011/03/10
  •   160
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

- Patients following a complete laryngectomy more than six months ago (voice rehabilitation by a voice prothesis welcome, but not required)
- so far no usage of HME-Filters
- >= 18 years of age
- written informed consent

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Exclusion Criteria

- intense mucus production
- bleedings of the lower respiratory tract (lung, bronchii, trachea)
- inability to change the HME-filter by themselves (e. g. hand or arm problems, coordination deficits)
- acking compliance
- participation in other interventional trials
- physical, mental or other inability to supply required information

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Atos Medical GmbH
    • Mr.  Reinhold  Halisch 
    • Müllheimerstrasse 3-7
    • D-53480  Troisdorf
    • Germany
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    • Atos Medical GmbH
    • Mr.  Reinhold  Halisch 
    • Müllheimerstrasse 3-7
    • D-53480  Troisdorf
    • Germany
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    • HNO-Abteilung, Bundeswehrkrankenhaus Ulm
    • Mr.  Dr. med.  Kai J.  Lorenz 
    • Oberer Eselsberg 40
    • D-89081  Ulm
    • Germany
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Sources of Monetary or Material Support

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    • Atos Medical GmbH
    • Mr.  Reinhold  Halisch 
    • Mülheimer Str. 3-7
    • D-53480  Troisdorf
    • Germany
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Status

  •   Recruiting withdrawn before 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.