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Risk Assessment for Postoperative Delirium (RAPID)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02377115
Recruitment Status : Completed
First Posted : March 3, 2015
Last Update Posted : April 25, 2018
Sponsor:
Information provided by (Responsible Party):
Nicolai Goettel, University Hospital, Basel, Switzerland

Brief Summary:
Postoperative delirium (POD) - a temporary state of confusion - is a frequent complication of surgery, which most commonly occurs in elderly patients. A tablet computer application that may assist preoperative risk screening for POD was developed at the University Hospital Basel in 2014. This study aims to investigate whether the computer program may assess the risk of a patient to develop POD.

Condition or disease Intervention/treatment Phase
Postoperative Delirium Other: Tablet computer application Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Risk Assessment for Postoperative Delirium: Derivation of a Self-Administered Tablet Computer-based Clinical Screening Tool
Study Start Date : March 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Arm Intervention/treatment
Study cohort
Tablet computer application
Other: Tablet computer application
Preoperatively, all study participants (entire cohort) will perform in the self-administered tablet computer-based tool to assess the risk of developing POD.




Primary Outcome Measures :
  1. Incidence of POD. [ Time Frame: Day 1-5 after surgery. ]
    Incidence of POD, detected by the DRS-R-98.


Secondary Outcome Measures :
  1. Severity of POD. [ Time Frame: Day 1-5 after surgery. ]
    Severity of POD, measured by the DRS-R-98.



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Elective major surgery
  • Age ≥65 years
  • Education ≥7 years
  • Fluency in German language
  • Informed written consent

Exclusion Criteria:

  • Dementia (Mini Mental State Examination (MMSE) <20 points)
  • Surgical intervention that would limit verbal communication
  • Cardiac surgery
  • Thoracic/pulmonary surgery
  • Intracranial surgery
  • Former or present participation in a cognitive research project

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02377115


Locations
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Switzerland
University Hospital Basel
Basel, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Nicolai Goettel, MD University Hospital, Basel, Switzerland
Additional Information:
Publications:

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Responsible Party: Nicolai Goettel, Nicolai Goettel, MD, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT02377115    
Other Study ID Numbers: RAPID
First Posted: March 3, 2015    Key Record Dates
Last Update Posted: April 25, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Nicolai Goettel, University Hospital, Basel, Switzerland:
Postoperative delirium
Postoperative cognitive decline
Postoperative cognitive dysfunction
Risk assessment
Tablet computer
Clinical screening tool
Additional relevant MeSH terms:
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Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders