Trial document





This trial has been registered retrospectively.
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  DRKS00008985

Trial Description

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Title

Laryngeal tube suction II or endotracheal intubation for laparoscopic radical prostatectomy in a head down position: A randomised controlled trial.

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

The aim of the study is to evaluate fesability, safety and patient comfort during airway management with the laryngeal tube suction II (LTS II) in patients undergoing laparoscopic prostate resection. In this study two groups of patients were compared: Patients who were ventilated with an LTS II and patients who were ventilated with a concentional tracheal tube.

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Brief Summary in Scientific Language

The laryngeal tube suction II (LTS II) is a supraglottic airway device (SAD) with a gastric drainage tube and enhanced seal properties when compared to other SAD. Therefore, it is in use in prehospital emergency airway management and has been proposed in situations with an elevated risk for aspiration. In the presented study we investigated the safety and efficacy of airway management and controlled mechanical ventilation with a LTS II in comparison with endotracheal intubation (ET) for radical endoscopic prostate surgery. In 28 patients who were randomized for LTS II the device had to be switched to ET mainly due to airway leakage and problems with mechanical ventilation. Additionally, we detected engorgement in 3 patients and a higher but not significant incidence of severe sore throat in the LTS II group. We therefore concluded that LTS II should not be used for airway management in patients undergoing radical endoscopic prostate surgery.

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Organizational Data

  •   DRKS00008985
  •   2015/09/23
  •   [---]*
  •   yes
  •   Approved
  •   445/12-bk , Ethikkommission an der Medizinischen Fakultät der Universität Leipzig
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Secondary IDs

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

  •   C61 -  Malignant neoplasm of prostate
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Interventions/Observational Groups

  •   Airwaymanagement with laryngeal tube suction LTS II
  •   Airwaymanagement with endotracheal tube
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Characteristics

  •   Interventional
  •   [---]*
  •   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

Successfull ventilation with LTS II

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Secondary Outcome

Aspiration
Ease and time of insertion
Soar throat, dysphagia, difficulties in swallowing
Conditions as rated by the responsible surgeon

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/04/23
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Patients undergoing endoscopic prostate resection

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Exclusion Criteria

ASA > II
Age < 18y
BMI > 30
missing informed consent
elevated risk for aspiraton of gastric content
participation in another interventional clinical trial

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Addresses

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    • Universität Leipzig, medizinische Fakultät
    • Liebigstr. 27b
    • 04103  Leipzig
    • Germany
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    • Universitätsklinikum Leipzig
    • Mr.  PD Dr.  Sven  Bercker 
    • Liebigstrasse 20
    • 04229  Leipzig
    • Germany
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    • Universitätsklinikum Leipzig
    • Mr.  PD Dr.  Sven  Bercker 
    • Liebigstrasse 20
    • 04103  Leipzig
    • Germany
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Sources of Monetary or Material Support

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    • Universität Leipzig, medizinische Faultät
    • Liebigstrasse 27b
    • 04103  Leipzig
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    •   [---]*
    •   [---]*
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Status

  •   Recruiting stopped after recruiting started
  •   2015/05/04
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Trial Publications, Results and other Documents

  •   Eur J Anaesthesiol. 2016 Oct 27. [Epub ahead of print]
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* This entry means the parameter is not applicable or has not been set.