Trial document




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  DRKS00010784

Trial Description

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Title

Safety of CO2 insufflation during coloscopy in patients with chronic hypercapnia

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Trial Acronym

CO2-Endo

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URL of the Trial

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Brief Summary in Lay Language

Analysis of safety of carbon dioxide insufflation during colorectal endoscopy for patients with chronic hypercapnia and intermittent non-invasuve home care ventilation. In guidelines for preventive medical checkup a colorectal endoscopy is recommended for all patients older than 55 years. This coloscopy is typically carried out with carbon dioxide insufflation. The analysis should investigate if using carbon dioxide insufflation there is a higher health risk for patients with chronic hypercapnia and non-invasive home care ventilation.

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Brief Summary in Scientific Language

Object of the study is to investigate the safety of prevention coloscopy with CO2-Insufflation in patients with chronic hypercapnia and already established non-invasive home care ventilation. We will survey the transcutaneous-PCO2 during coloscopy, respiratory rate and oxygen saturation (with pulse oximetry) and capillary blood gas analysis before and after Coloscopy.

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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

  •   DRKS00010784
  •   2017/03/15
  •   [---]*
  •   yes
  •   Approved
  •   01/2017, Ethik-Kommission der Universität Witten/Herdecke
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Secondary IDs

  •   U1111-1184-9025 
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Health Condition or Problem studied

  •   J96.11 -  [generalization J96.1: Chronic respiratory failure]
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Interventions/Observational Groups

  •   Patients with chronic hypercapnia and intermittent non-invasive home care ventilation who are having a prevention coloscopy with air-insufflation
  •   Patients with chronic hypercapnia and intermittent non-invasive home care ventilation who are having a prevention coloscopy with cO2-insufflation
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

The primary endpoint is the difference between baseline transcutaneous PCO2 and maximum PCO2 during coloscopy.

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Secondary Outcome

respiratory rate, oxygen saturation (with pulse oximetry) during examination, heart rate, amount of sedation, time of examination

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2017/04/10
  •   12
  •   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

Chronic hypercapnia with intermitttent non-invasive home care ventilation (for at least 6 months)

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Exclusion Criteria

Acute exacerbation of respiratory situation (pH < 7,35)

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinikum Konstanz, II. Medizin
    • Mr.  Dr. med.  Stephan  Walterspacher 
    • Luisenstr. 7
    • 78464  Konstanz
    • Germany
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    • Klinikum Konstanz, II. Medizin
    • Mr.  Dr. med.  Stephan  Walterspacher 
    • Luisenstr. 7
    • 78464  Konstanz
    • Germany
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    • Klinikum Konstanz, II. Medizin
    • Mr.  Dr. med.  Stephan  Walterspacher 
    • Luisenstr. 7
    • 78464  Konstanz
    • Germany
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Sources of Monetary or Material Support

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    • Klinikum Konstanz, II. Medizin
    • Mr.  Dr. med.  Stephan  Walterspacher 
    • Luisenstr. 7
    • 78464  Konstanz
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2020/08/31
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Trial Publications, Results and other Documents

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