Trial document




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  DRKS00017546

Trial Description

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Title

The Anesthesia Brain Safety Project:
Incidence of postoperative delirium after ENT surgery in elderly patients in the Catholic Hospital Bochum - an observational study

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Delirium has an acute onset and is a fluctuating state of confusion that often occurs after surgical intervention in the elderly.
By using the Nursing Delirium screening scale (Nu-DESC) we investigate the occurrence of delirium in the elderly during inpatient treatment in an otorhinolaryngology department.
In addition, cognitive testing is being performed before and after surgery and at follow-up appointments.
We examine to what extent a cognitive impairment can be the cause and consequence of a delirium.

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Brief Summary in Scientific Language

We use the Nu-DESC to determine the incidence of postoperative delirium after ENT surgery in the elderly.
We compare the cognitive status and anesthesia data between delirious and non-delirious patients.

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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

  •   DRKS00017546
  •   2019/06/27
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  •   yes
  •   Approved
  •   18-6578, Ethik-Kommission der Medizinischen Fakultät der Ruhr-Universität Bochum
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Secondary IDs

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Health Condition or Problem studied

  •   F05 -  Delirium, not induced by alcohol and other psychoactive substances
  •   postoperative cognitive dysfunction (POCD)
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Interventions/Observational Groups

  •   Determination of the Nu-DESC delirium score on a normal ward with patients over 65 years and ENT surgery.
  •   Determination of the Nu-DESC delirium score on a normal ward with patients over 65 years without ENT surgery.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Diagnostic
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Incidence of postoperative delirium after ENT interventions during hospitalization.

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Secondary Outcome

Determination of the influence of different parameters on the occurrence of a delirium:

- Results of cognitive testing from 5 subtests of the ALAcog task pool (after admission, before discharge, at follow-up after approx. 4 weeks); Hi-MOCA (hearing-impaired montreal cognitive assessment)

- Results of the Shulman clock test
- MWT-B result
- School years / highest degree / profession achieved
- PHQ-2 scores (depression screening for major symptoms of depression)
- BPI (Brief pain inventory)
- Indication for operation
- Indication for therapy
- Data (e.g., vital parameters) from the anesthesia protocols
- NuDESC score postoperative
- NRS score plus affect question and the desire to intensify the pain therapy
- comorbidities
- medicines
- hearing test (if available)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2019/07/02
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   65   Years
  •   no maximum age
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Additional Inclusion Criteria

Age over 65 years and ENT surgery in the St. Elisabeth Hospital

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Exclusion Criteria

- Rejection of participation in the study by the patient or inability to agree
- impossibility to perform the neurocognitive tests, e.g. due to ventilation, motor restrictions (eg paresis)
- Patients with a diagnosed psychiatric disorder, e.g. Schizophrenia, severe depression
- Advanced dementia with the impossibility to do daily tasks without help.
- Mental retardation (MWT-B below 21 points)
- Significantly complicated communication, e.g. due to a language barrier
- Emergency intervention with indication for immediate operative intervention
- terminal underlying disease with a life expectancy of less than 6 months

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Addresses

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    • Katholisches Klinikum Bochum
    • Bleichstraße 15
    • 44787  Bochum
    • Germany
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    • Klinik für Hals-Nasen-Ohrenheilkunde, Katholisches Klinikum Bochum
    • Ms.  Dr. med.  Christiane  Völter 
    • Bleichstraße 15
    • 44787  Bochum
    • Germany
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    • Klinik für Anästhesiologie und operative Intensivmedizin, Katholisches Klinikum Bochum
    • Mr.  Prof. Dr. med  Thomas  Weber 
    • Bleichstraße 15
    • 44787  Bochum
    • Germany
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    • Klinik für Anästhesiologie und operative Intensivmedizin, Katholisches Klinikum Bochum
    • Mr.  Dr. med.  Philipp  Gude 
    • Bleichstraße 15
    • 44787  Bochum
    • Germany
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Sources of Monetary or Material Support

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    • Katholisches Klinikum Bochum
    • Bleichstraße 15
    • 44787  Bochum
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2020/03/10
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Trial Publications, Results and other Documents

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