Out of hospital care of OHS patients receiving non-invasive ventilation - a randomised controlled trial (OHONIV)
Organizational Data
- DRKS-ID:
- DRKS00028287
- Recruitment Status:
- Recruiting planned
- Date of registration in DRKS:
- 2022-02-25
- Last update in DRKS:
- 2022-02-25
- Registration type:
- Prospective
Acronym/abbreviation of the study
OHONIV
URL of the study
No Entry
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.
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.
Health condition or problem studied
- ICD10:
- E66.2 - Extreme obesity with alveolar hypoventilation
- ICD10:
- J96.1 - Chronic respiratory failure
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- OHS (obesity hypoventilation syndrome) Patients with pre-existing home non-invasive ventilation - Ventilation controls by inpatient diagnostics.
- Arm 2:
- OHS Patients with pre-existing home non-invasive ventilation - Ventilation controls by outpatient diagnostics.
Endpoints
- Primary outcome:
- Health-related quality of life measured by Severe Respiratory Insufficiency Questionnair (SRI) after 12 months
- 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.
Study Design
- Purpose:
- Other
- Allocation:
- Randomized controlled study
- Control:
-
- Other
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting planned
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- University medical center Kliniken der Stadt Köln gGmbh, Universität Witten/Herdecke Köln
- Medical center Klinikum Konstanz, Gesundheitsverbund Landkreis Konstanz Konstanz
Recruitment period and number of participants
- Planned study start date:
- 2022-03-02
- Actual study start date:
- No Entry
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 20
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- 99 Years
- 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
Exclusion Criteria
- Patient age < 18 years - Mental retardation - Missing informed consent
Addresses
Primary Sponsor
- Address:
- Kliniken der Stadt Köln gGmbHProf. Dr. Wolfram WindischOstmerheimer Str. 20051109 KölnGermany
- Telephone:
- 0221890718929
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Kliniken der Stadt Köln gGmbHDr. Sarah SchwarzOstmerheimer Str. 20051109 KölnGermany
- Telephone:
- 0221890718337
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Kliniken der Stadt Köln gGmbHDr. Sarah SchwarzOstmerheimer Str. 20051109 KölnGermany
- Telephone:
- 0221890718337
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Kliniken der Stadt Köln gGmbHDr. Sarah SchwarzOstmerheimer Str. 20051109 KölnGermany
- Telephone:
- 0221890718337
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Kliniken der Stadt Köln gGmbHOstmerheimer Str. 20051109 KölnGermany
- Telephone:
- 0221890718929
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.kliniken-koeln.de
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Universität Witten/HerdeckeAlfred-Herrhausen-Str. 5058448 WittenGermany
- Telephone:
- +49-2302-926740
- Fax:
- +49-2302-926739
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2021-08-10
- Ethics committee number:
- 184/2021
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2021-09-14
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry