Trial document





This trial has been registered retrospectively.
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  DRKS00008007

Trial Description

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Title

Classical laryngeal mask, Proseal laryngeal mask or endotracheal tube for percutaneous dalatational tracheostomy: A comparison of quality of ventilation, view and complications.

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Tracheotomy is necessary in some critically ill patients. During the operation for tracheotomy the ventilation may be worse, because the ventilation tube is obstructed by an additional instrument for monitoring the operation from inside the trachea. This may be deleterious for patients with acute brain injuries.
The aim of the investigation is to assess other instruments for ventilation (laryngal mask airways). Beacause their internal diameter is larger, the ventilation may be less impaired.

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Brief Summary in Scientific Language

increasing CO2 is crucial in patients with head injury. During PDT, often CO2 increases. therefore we investigate, which airway during percutaneous dilatational tracheostomy (classical laryngeal mask, ProSeal laryngeal mask or endotracheal tube) raises fewest of all paCO2?

Secondary issue: which differences existet by using the different airways regarding :- respiratory minute volume
- oxygenation (SaO2, paO2)
- complications of ventilation
- accidental extubation
- changing artificial airway concerning impossible ventilation
- damage of the bronchoscope
- visibility conditions during percutaneous dilatational tracheostomy

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00008007
  •   2015/04/16
  •   [---]*
  •   yes
  •   Approved
  •   A 129/09, Ethikkommission der Christian-Albrechts-Universität zu Kiel
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Secondary IDs

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Health Condition or Problem studied

  •   G93.6 -  Cerebral oedema
  •   increase of paCO2 during percutaneous dilatational trachostomy
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Interventions/Observational Groups

  •   endotracheal tube for bronchoscopy and ventilation during tracheostomy. Primary endpoint of the investigation: paCO2
  •   laryngeal mask airway Pro Seal for bronchoscopy and ventilation during tracheostomy. Primary endpoint of the investigation: paCO2
  •   laryngeal mask airway classic for bronchoscopy and ventilation during tracheostomy. Primary endpoint of the investigation: paCO2
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

To capture paCO2 blodd gas analysises were realised by reference to a standarized protocoll:
- before FiO2 1,0 (before starting to implement measures)
- 10 minutes after preoxygenation with FiO2 1,0
- before puncture the trachea
1 minute postoperative

documented were pH, paCO2, PaO2 and sHCO3-

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Secondary Outcome

Following haemodynamic and respiratory parameters were documented by a stadarized protocoll before FiO2 1,0, 10 minutes after FiO2 1,0, after optimized parameters of ventilation, before puncture of the trachea and 1 minute postoperativ:

-Heart rate
- MAP
- SaO2
- tidal volume
- respiratory minute volume
- breathing frequency
- end-tidal CO2
- PEEP


The assessment of the single steps of the procedure were documented by a standarized scoring (1-4).
scoring during the steps A-F:
A: Insertion of laryngeal mask, returning endotrachealtube
B: Insertion of the bronchoscope
C: identification of tracheal strutures
D: controll of the puncture
E: controll of the dilatation
F: View of the trachea

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2010/01/11
  •   104
  •   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

- indication for tracheostomy
- >2 failed extubations
- prolonged ventilation > 1week
- persistant impaired ability to swallow
- persistant missing cough reflex

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Exclusion Criteria

- exsessive struma
- previous complicated endotracheal intubation (Cormack/Lehane 4)
- missing consent
- < 18 years old
- pregnancy

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Addresses

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    • KrankenhausdirektorDiakonissenanstalt Flensburg
    • Mr.  Dr.  Christian  Peters 
    • Marienhölzungsweg 2
    • 24939  Flensburg
    • Germany
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    •   0461/812-0
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    • Klinik für Anästhesiologie, Intensivmedizin und SchmerztherapieDiakonissenanstalt Flensburg
    • Mr.  Prof. Dr.  Ulf  Linstedt 
    • Marienhölzungsweg 2
    • 24939  Flensburg
    • Germany
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    • Diako Flensburg
    • Mr.  Prof. Dr.  Ulf  Linstedt 
    • Knuthstr. 1
    • 24937  Flensburg
    • Germany
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Sources of Monetary or Material Support

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    • Diakonissenkrankenhaus
    • Knuthstr. 1
    • 24937  Flensburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/06/05
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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.