Diagnostics under sedation in people with intellectual disability or complex multiple disabilities in a medical center for adults with disabilities (MZEB) - secondary analysis of file data
Organizational Data
- DRKS-ID:
- DRKS00033066
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2023-12-28
- Last update in DRKS:
- 2023-12-28
- Registration type:
- Retrospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
Brief summary in lay language
No Entry
Brief summary in scientific language
Standard medical care often does not meet the treatment needs of people with intellectual disabilities or complex multiple disabilities. To improve the quality of care for this target group, medical treatment centers for adults with disabilities (MZEB) have therefore existed in Germany since 2015. For a relevant proportion of people in this target group, examinations can often only be carried out with the help of sedation due to a lack of cooperation. There are currently no studies or recommendations for action regarding sedation measures for patients at a MZEB. This study is a retrospective secondary analysis of data from medical records. Based on the systematic review of these files, around 100 anonymized data sets from patients of a MZEB in Germany are evaluated. The data was collected in this MZEB - in the course of diagnostic interventions under sedation - within a predefined period. The data collection instrument used was a survey database that had previously been compiled using a pretest. Once the data collection has been completed, it will be transferred to a statistical software platform and analyzed for exploratory purposes. The intended research work is to explore data from patients of an MZEB with regard to indications, implementation, outcome and frequency of sedation and to investigate certain key characteristics. The aim of the project is to make a possible contribution to improving the medical care of people with intellectual disabilities and/or complex multiple disabilities through the procedure described.
Health condition or problem studied
- ICD10:
- F70-F79 - Mental retardation
- ICD10:
- F84 - Pervasive developmental disorders
- ICD10:
- F84.0 - Childhood autism
- ICD10:
- F84.1 - Atypical autism
- ICD10:
- F84.2 - Rett syndrome
- ICD10:
- F84.5 - Asperger syndrome
- ICD10:
- G40 - Epilepsy
- ICD10:
- G80-G83 - Cerebral palsy and other paralytic syndromes
- ICD10:
- Q00-Q99 - Congenital malformations, deformations and chromosomal abnormalities
- Healthy volunteers:
- No
Interventions, Observational Groups
- Arm 1:
- Retrospective anonymized data from medical records of people with intellectual disability and/or complex multiple disabilities who received diagnostic intervention under sedation in a Medical Center for Adults with Disabilities (MZEB) are examined. The use of treatment in a MZEB is based on the type, severity or complexity of the patient's disability. In addition, patients require a referral from an authorized physician, dentist or facility for treatment at a MZEB. The reason for sedation is that these patients are unable to cooperate with diagnostic interventions, such as imaging. Diagnostics under sedation take place under vital parameter control and under the guidance of a sedation protocol.
Endpoints
- Primary outcome:
- Exploration of the drugs administered for sedation, their dosage and route of administration, as well as the characteristics of the patients examined under sedation.
- Secondary outcome:
- Not specified
Study Design
- Purpose:
- Diagnostic
- Retrospective/prospective:
- Retrospective
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- Epidemiological study
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- Other Medizinisches Zentrum für Erwachsene mit Behinderung (MZEB) am Ev. Krankenhaus Hagen-Haspe, Klinik für Inklusive Medizin, Brusebrinkstr. 20, 58135 Hagen, Deutschland Hagen
Recruitment period and number of participants
- Planned study start date:
- 2023-12-04
- Actual study start date:
- 2023-12-04
- Planned study completion date:
- 2024-09-30
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 100
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- - Patient of a MZEB who receives a diagnostic measure under sedation due to a lack of cooperation - People with intellectual disability and/or complex multiple disabilities (ICD-10 codes: F70.0, F70.1, F71.0, F71.1, F72.0, F72.1, F73.0, F73.1, F74.0, F74.1, F78.0, F78.1, F79.0, F79.1, F84.- , F84.0, F84.1, F84.2, F84.5, G40.-, G80.-, G81.-, G82, G83.-, Q00-Q99) - Individuals of any ethnic background
Exclusion Criteria
- Age: <18 years - Patients for whom sedation is due to the nature of the procedure and the indication for sedation is not limited ability to cooperate
Addresses
Primary Sponsor
- Address:
- Evangelische Stiftung Volmarstein, Medizinisches Zentrum für Erwachsene mit Behinderung (MZEB) am Ev. Krankenhaus Hagen-Haspe, Klinik für Inklusive MedizinDr. med. Jörg StockmannBrusebrinkstr. 2058135 HagenGermany
- Telephone:
- +49 23 31 – 476 24 81
- Fax:
- -/-
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://evk-haspe.de/kliniken-zentren/klinik-fuer-inklusive-medizin/kurzvorstellung
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Universität Witten/Herdecke Institut für Allgemeinmedizin und Ambulante Gesundheitsversorgung, Lehrstuhl für Allgemeinmedizin I und Interprofessionelle VersorgungProf. Dr. oec. troph. Eva MünsterAlfred-Herrhausen-Straße 5058448 WittenGermany
- Telephone:
- +49 2302 / 926-7301
- Fax:
- +49 (0)2302 / 926-745
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.uni-wh.de/gesundheit/department-fuer-humanmedizin/lehrstuehle-institute-und-zentren/lehrstuhl-fuer-allgemeinmedizin-i-und-interprofessionelle-versorgung/
Contact for Public Queries
- Address:
- Universität Witten/Herdecke Institut für Allgemeinmedizin und Ambulante Gesundheitsversorgung, Lehrstuhl für Allgemeinmedizin I und Interprofessionelle VersorgungSaskia BückerAlfred-Herrhausen-Straße 5058448 WittenGermany
- Telephone:
- +49 157-729 11 680
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.uni-wh.de/gesundheit/department-fuer-humanmedizin/lehrstuehle-institute-und-zentren/lehrstuhl-fuer-allgemeinmedizin-i-und-interprofessionelle-versorgung/
Principal Investigator
- Address:
- Universität Witten/Herdecke Institut für Allgemeinmedizin und Ambulante Gesundheitsversorgung, Lehrstuhl für Allgemeinmedizin I und Interprofessionelle VersorgungProf. Dr. oec. troph. Eva MünsterAlfred-Herrhausen-Straße 5058448 WittenGermany
- Telephone:
- +49 2302 / 926-7301
- Fax:
- +49 (0)2302 / 926-745
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.uni-wh.de/gesundheit/department-fuer-humanmedizin/lehrstuehle-institute-und-zentren/lehrstuhl-fuer-allgemeinmedizin-i-und-interprofessionelle-versorgung/
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Evangelische Stiftung VolmarsteinHartmannstraße 2458300 Wetter (Ruhr)Germany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Universität Witten/HerdeckeAlfred-Herrhausen-Str. 5058448 WittenGermany
- Telephone:
- +49-2302-926740
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.ethik-kommission-uwh.de/
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2023-08-09
- Ethics committee number:
- S-213/2023
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2023-08-24
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