Trial document




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  DRKS00028287

Trial Description

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Title

Out of hospital care of OHS patients receiving non-invasive ventilation - a randomised controlled trial (OHONIV)

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Trial Acronym

OHONIV

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URL of the Trial

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Brief Summary in Lay Language

The incidence and prevalence of patients requiring ventilation due to obesity has been increasing for years. This condition is also called obesity hypoventilation syndrome (OHS). There are very few data on whether the control of non-invasive ventilation in OHS patients initiated as inpatients can also be carried out under outpatient conditions. Existing studies from the Netherlands show that outpatient setting of non-invasive ventilation is feasible.
The aim of this study is to demonstrate that outpatient control of non-invasive ventilation in OHS patients can lead to an improvement in patient satisfaction, measured by the primary endpoint of health-related quality of life, without compromising ventilation quality.

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Brief Summary in Scientific Language

Prospective, multicentre, randomised controlled cohort study (two arms) in patients with known obesity hypoventilation syndrome (OHS). The aim is to investigate whether outpatient control of NIV therapy in OHS patients can improve patient satisfaction as measured by the primary endpoint of health-related quality of life without compromising ventilatory quality. Secondary endpoints are:
1. descriptive analysis of the demographic data and the heakthcare situation
2. identification of influencing factors by evaluating the cost analysis, ventilation quality based on the ABG on the day, therapy adherence and mortality
3. evaluation of the S3 NIV with regard to quality of life and NIV-related symptoms.

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

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00028287
  •   2022/02/25
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  •   yes
  •   Approved
  •   184/2021, Ethik-Kommission der Universität Witten/Herdecke
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Secondary IDs

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Health Condition or Problem studied

  •   E66.2 -  Extreme obesity with alveolar hypoventilation
  •   J96.1 -  Chronic respiratory failure
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Interventions/Observational Groups

  •   OHS (obesity hypoventilation syndrome) Patients with pre-existing home non-invasive ventilation - Ventilation controls by inpatient diagnostics.
  •   OHS Patients with pre-existing home non-invasive ventilation - Ventilation controls by outpatient diagnostics.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Other
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Health-related quality of life measured by Severe Respiratory Insufficiency Questionnair (SRI) after 12 months

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Secondary Outcome

1. descriptive analysis of the demographic data and the health care situation
2. identification of influencing factors by evaluating the cost analysis, ventilation quality on the basis of the ABG on the day, therapy adherence and mortality
3. evaluation of the S3 NIV with regard to quality of life and NIV-related symptoms.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
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Recruitment

  •   Planned
  •   2022/03/02
  •   20
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   99   Years
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Additional Inclusion Criteria

- Obesity hypoventilation syndrome
- Definition according to the ATS Guidelines
- NIV therapy for at least 3 months
- Signed informed consent
- Patient age ≥ 18 years

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Exclusion Criteria

- Patient age < 18 years
- Mental retardation
- Missing informed consent

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Addresses

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    • Kliniken der Stadt Köln gGmbH
    • Mr.  Prof. Dr.  Wolfram  Windisch 
    • Ostmerheimer Str. 200
    • 51109  Köln
    • Germany
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    • Studienzentrum der Inneren Medizin I & II am Klinikum Konstanz
    • Mr.  Dr.  Stephan  Walterspacher 
    • Mainaustraße 35
    • 78464  Konstanz
    • Germany
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    • Kliniken der Stadt Köln gGmbH
    • Ms.  Dr.  Sarah  Schwarz 
    • Ostmerheimer Str. 200
    • 51109  Köln
    • Germany
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    • Kliniken der Stadt Köln gGmbH
    • Ms.  Dr.  Sarah  Schwarz 
    • Ostmerheimer Str. 200
    • 51109  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Kliniken der Stadt Köln gGmbH
    • Mr.  Prof. Dr.  Wolfram  Windisch 
    • Ostmerheimer Str. 200
    • 51109  Köln
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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