Trial document




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  DRKS00000715

Trial Description

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Title

Evaluation of endotracheal intubation performed with a semirigid endoscope (Bonfils-Fibrescope) in toddlers and infants.

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

An essential component of anesthesia treatment of a child is the introduction of a breathing tube into the lungs. This is usually placed under direct vision by using a spatula (Laryngoscope) to lift the tongue. In cases of a difficult or impossible direct view, there are several technical tools. Those include one in which a camera is mounted on the tip of the laryngoscope-blade, this tool is called a video laryngoscope. Other options are so-called endoscopic optics - these are tubes through which you can watch with a camera. Their used for this purpose is widespread. The so-called Bonfils-optics is a rigid, pre-formed fibreoptic. We have much experience with this and feel that it is a very valuable tool in the child's airway. In this study we want to prove this scientifically.

During the first part, we study healthy children with normal airway. We provide the view on the larynx of the child first with the usual method using a laryngoscope. Then we compare this either still with a video-laryngoscope or with the Bonfils-scope. We will compare the quality and timing of intubation.

In the second part, we study children with difficult airway, which can be fully ventilated with a mask, but need to be intubated. We investigate again the quality and timing of intubation, which we carry out in equal parts with either a flexible optic (bronchoscope) or the Bonfils-optic.
First part of the investaigation is completed, evaluated and submitted for publication.

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Brief Summary in Scientific Language

When a difficult intubationoccurs, various technical tools are available. Optical systems that allow a view of the vocal cords (glottis) are preferable compared to "blind" procedures, because they enable a reduced risk of injury and a greater success rate. The gold standard for difficult intubations are flexible fiber-optics, as they are used for flexible bronchoscopy.
In the Bonfils-optic is a rigid tube in which there is a fiber optic system, and is curved at the tip by 40 °. It has the great advantage that its technique is very similar to the intubation under direct laryngoscopic view and thus allows a much smaller need for exercise with good rates of successful and atraumatic intubation. In addition, the time required to prepare and follow-up of the optics and the costs are much lower as if using a flexible bronchoscope. For these reasons, we think that the Bonfils-scope is an ideal instrument for intubation in difficult airway in children.
The only clinical study with the Bonfils-optic in children uses a wrong technique, wich is different from our experience and the first description by the developer. Therefore this investigation shows a low rate of succes during intubation with the bonfils-scope and concludes this device is inappropriate for children. This is contrary to a number of case reports and our many years of clinical experience using the right technique. We are conducting the present observational study to prove that the Bonfils-optic is an excellent tool for the difficult intubation in children and infants, when its used appropriate.
In our planned study is an open, randomized, controlled study to compare established intubation-devices with diagnostic and therapeutic aspects.
In the first part of the investigation, we compare the quality of intubation in children with uncomplicated airway using the Bonfils-optic and the already evaluated technology of video-laryngoscopy with direct laryngoscopy. In the second part of the investigation, we compare the quality of intubation in children with a difficult airway using the Bonfils intubation with the optics to a flexible fiber optics (bronchoscope) with expected and unexpected difficult airway.
If we can document the expected results, this would legitimize the Bonfils-optics as an valuable an easy-to-use equipement for difficult intubation in children. We are convinced that even in hospitals with a limited range of equipment and experience, the safety of the care for children can be increased by using the Bonfils-scope.

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Organizational Data

  •   DRKS00000715
  •   2011/02/07
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  •   yes
  •   Approved
  •   71/2010, Ethik-Kommission der Universität Witten/Herdecke
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Secondary IDs

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Health Condition or Problem studied

  •   difficult airway
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Interventions/Observational Groups

  •   Normal airway, videolaryngoscope
  •   normal airway, bonfils-scope
  •   difficult airway, bonfils-scope
  •   difficult airway, flexible fiberscope
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
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Primary Outcome

time needed for intubation, from touching the instruments until firts Ventilation with measured exhaled CO2, measured with a stop-watch during intubation

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Secondary Outcome

Quality of visualisation and rate of succes of intubation

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2011/03/09
  •   170
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

First part of the study: children under 7 years who must be intubated electively

Second part of the study: All patients at the pediatric hospital, which have a difficult airway and must be intubated

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Exclusion Criteria

first part of the study: ASA> II, both parts: cardiopulmonary limitation
No mask ventilation possible

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Addresses

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Sources of Monetary or Material Support

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    • Lehrstuhl für Anästhesiologie II Der Universität Witten/Herdecke
    • Prof. Dr. med.   Frank   Wappler 
    • Ostmerheimer Str. 200
    • 51109  Köln
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2013/03/15
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Trial Publications, Results and other Documents

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