Trial document





This trial has been registered retrospectively.
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  DRKS00005645

Trial Description

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Title

The epidemiology of obstructive sleep disorders in the thoracic surgery patient collective: a risc factor for postoperative morbidity?

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Obstructive sleep apnea is well known to be a risk factor for lung and heart complications after surgery in orthopedic patients as well as in visceral surgery patients. This association is described in retrospective analyses.
The current study is a prospective evaluation of patients in the thoracic surgery unit with the intention to evaluate a possible association of OSA with postoperative complications of the heart and the lung. OSA will be detected with two questionaires and including ApnoeaLink and Sleepminder as a technical method

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Brief Summary in Scientific Language

Prospective cross sectional study to evaluate the prevalence and severity of OSA and its possible association with postoperative morbidity in the thoracic surgery patient. Two technical screenings will be used (ApneaLink®, Company ResMed und Sleepminder®, Company BiancaMed) the thoracic surgery patients. All patients scheduled for thoracotomy will be included. As a possible control group, patients with known OSA and CPAP therapy will be evaluated for complications as well.

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Organizational Data

  •   DRKS00005645
  •   2014/05/14
  •   [---]*
  •   yes
  •   Approved
  •   13-5589-BO, Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen
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Secondary IDs

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Health Condition or Problem studied

  •   G47.31 -  [generalization G47.3: Sleep apnoea]
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Interventions/Observational Groups

  •   Patients scheduled for thoracotomy get a preoperative OSA-screening including 2 questionaires, ApnoeaLink and Sleepminder. The postoperative cours including complications are prospectively recorded. Patients with a known obstructive sleeping disorder who use a breathin mask will be conducted as a control group with the registration of postoperative complications.
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Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Screening
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Primary end point is the prevalence of Obstructive sleep apnoe in the thoracic surgery patients cohort.

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Secondary Outcome

1. Frequency of postoperative complications in the patient with obstructive sleepind disorder compared with the patient without.

2. Diagnostic value of questionaires compared to technical OSA screening.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2013/12/04
  •   321
  •   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

medical indication for thoracotomy, informed consent

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Exclusion Criteria

a. hypercapnia
b. Demencia or severe depression or other neurologic diseases reducing awareness and understanding of the questionaires
c. recent myocardial infarction or stroke or persistent hypertention non-reactive on medical therapy within the last 12 weeks
d. no informed consent

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Addresses

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    • Ruhrlandklinik Essen, Westdeutsches Lungenzentrum am Universitätsklinikum Essen, gGmbH
    • Tüschener Weg 40
    • 45239  Essen
    • Germany
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    • Ruhrlandklinik, Westdeutsches Lungenzentrum
    • Ms.  Dr.  Stefanie  Werther 
    • Tüschener Weg 40
    • 45239  Essen
    • Germany
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    • Ruhrlandklinik
    • Mr.  PD Dr.  Stefan  Welter 
    • Tüschener Weg 40
    • 45239  Essen
    • Germany
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    • Ruhrlandklinik, Westdeutsches Lungenzentrum
    • Mr.  PD Dr.  Stefan  Welter 
    • Tüschener Weg 40
    • 45239  Essen
    • Germany
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Sources of Monetary or Material Support

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    • Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen
    • Mr.  PD Dr.  Stefan   Welter 
    • Tueschener Weg 40
    • 45239  Essen
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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