Risk Assessment for Postoperative Delirium

NCT02377115 | Completed

• 1 other identifier: RAPID
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Delirium

Keywords

Postoperative delirium; Postoperative cognitive decline; Postoperative cognitive dysfunction; Risk assessment; Tablet computer; Clinical screening tool

Outcome Measures

Primary Outcomes (1)

• Incidence of POD.

  Incidence of POD, detected by the DRS-R-98.

  Day 1-5 after surgery.

Secondary Outcomes (1)

• Severity of POD.

  Day 1-5 after surgery.

Study Arms (1)

Study cohort

OTHER

Tablet computer application

Other: Tablet computer application

Interventions

Tablet computer application OTHER

Preoperatively, all study participants (entire cohort) will perform in the self-administered tablet computer-based tool to assess the risk of developing POD.

Study cohort

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

Location

Related Publications (30)

• Schrader SL, Wellik KE, Demaerschalk BM, Caselli RJ, Woodruff BK, Wingerchuk DM. Adjunctive haloperidol prophylaxis reduces postoperative delirium severity and duration in at-risk elderly patients. Neurologist. 2008 Mar;14(2):134-7. doi: 10.1097/NRL.0b013e318166b88c.

  PMID: 18332845 BACKGROUND

• Steiner LA. Postoperative delirium. Part 1: pathophysiology and risk factors. Eur J Anaesthesiol. 2011 Sep;28(9):628-36. doi: 10.1097/EJA.0b013e328349b7f5.

  PMID: 21785356 BACKGROUND

• Dasgupta M, Hillier LM. Factors associated with prolonged delirium: a systematic review. Int Psychogeriatr. 2010 May;22(3):373-94. doi: 10.1017/S1041610209991517. Epub 2010 Jan 21.

  PMID: 20092663 BACKGROUND

• Dasgupta M, Dumbrell AC. Preoperative risk assessment for delirium after noncardiac surgery: a systematic review. J Am Geriatr Soc. 2006 Oct;54(10):1578-89. doi: 10.1111/j.1532-5415.2006.00893.x.

  PMID: 17038078 BACKGROUND

• Parente D, Luis C, Veiga D, Silva H, Abelha F. Congestive heart failure as a determinant of postoperative delirium. Rev Port Cardiol. 2013 Sep;32(9):665-71. doi: 10.1016/j.repc.2012.12.020. Epub 2013 Sep 6.

  PMID: 24011864 BACKGROUND

• Zakriya KJ, Christmas C, Wenz JF Sr, Franckowiak S, Anderson R, Sieber FE. Preoperative factors associated with postoperative change in confusion assessment method score in hip fracture patients. Anesth Analg. 2002 Jun;94(6):1628-32, table of contents. doi: 10.1097/00000539-200206000-00050.

  PMID: 12032042 BACKGROUND

• Kalisvaart KJ, Vreeswijk R, de Jonghe JF, van der Ploeg T, van Gool WA, Eikelenboom P. Risk factors and prediction of postoperative delirium in elderly hip-surgery patients: implementation and validation of a medical risk factor model. J Am Geriatr Soc. 2006 May;54(5):817-22. doi: 10.1111/j.1532-5415.2006.00704.x.

  PMID: 16696749 BACKGROUND

• Marcantonio ER, Goldman L, Mangione CM, Ludwig LE, Muraca B, Haslauer CM, Donaldson MC, Whittemore AD, Sugarbaker DJ, Poss R, et al. A clinical prediction rule for delirium after elective noncardiac surgery. JAMA. 1994 Jan 12;271(2):134-9.

  PMID: 8264068 BACKGROUND

• Inouye SK, Viscoli CM, Horwitz RI, Hurst LD, Tinetti ME. A predictive model for delirium in hospitalized elderly medical patients based on admission characteristics. Ann Intern Med. 1993 Sep 15;119(6):474-81. doi: 10.7326/0003-4819-119-6-199309150-00005.

  PMID: 8357112 BACKGROUND

• Freter SH, Dunbar MJ, MacLeod H, Morrison M, MacKnight C, Rockwood K. Predicting post-operative delirium in elective orthopaedic patients: the Delirium Elderly At-Risk (DEAR) instrument. Age Ageing. 2005 Mar;34(2):169-71. doi: 10.1093/ageing/afh245. No abstract available.

  PMID: 15713861 BACKGROUND

• Rudolph JL, Jones RN, Levkoff SE, Rockett C, Inouye SK, Sellke FW, Khuri SF, Lipsitz LA, Ramlawi B, Levitsky S, Marcantonio ER. Derivation and validation of a preoperative prediction rule for delirium after cardiac surgery. Circulation. 2009 Jan 20;119(2):229-36. doi: 10.1161/CIRCULATIONAHA.108.795260. Epub 2008 Dec 31.

  PMID: 19118253 BACKGROUND

• Long LS, Shapiro WA, Leung JM. A brief review of practical preoperative cognitive screening tools. Can J Anaesth. 2012 Aug;59(8):798-804. doi: 10.1007/s12630-012-9737-1. Epub 2012 May 26.

  PMID: 22638676 BACKGROUND

• Egerhazi A, Berecz R, Bartok E, Degrell I. Automated Neuropsychological Test Battery (CANTAB) in mild cognitive impairment and in Alzheimer's disease. Prog Neuropsychopharmacol Biol Psychiatry. 2007 Apr 13;31(3):746-51. doi: 10.1016/j.pnpbp.2007.01.011. Epub 2007 Jan 16.

  PMID: 17289240 BACKGROUND

• Erlanger DM, Kaushik T, Broshek D, Freeman J, Feldman D, Festa J. Development and validation of a web-based screening tool for monitoring cognitive status. J Head Trauma Rehabil. 2002 Oct;17(5):458-76. doi: 10.1097/00001199-200210000-00007.

  PMID: 12802255 BACKGROUND

• Fillit HM, Simon ES, Doniger GM, Cummings JL. Practicality of a computerized system for cognitive assessment in the elderly. Alzheimers Dement. 2008 Jan;4(1):14-21. doi: 10.1016/j.jalz.2007.09.008.

  PMID: 18631946 BACKGROUND

• Levinson D, Reeves D, Watson J, Harrison M. Automated neuropsychological assessment metrics (ANAM) measures of cognitive effects of Alzheimer's disease. Arch Clin Neuropsychol. 2005 May;20(3):403-8. doi: 10.1016/j.acn.2004.09.001.

  PMID: 15797175 BACKGROUND

• Saxton J, Morrow L, Eschman A, Archer G, Luther J, Zuccolotto A. Computer assessment of mild cognitive impairment. Postgrad Med. 2009 Mar;121(2):177-85. doi: 10.3810/pgm.2009.03.1990.

  PMID: 19332976 BACKGROUND

• Falleti MG, Maruff P, Collie A, Darby DG. Practice effects associated with the repeated assessment of cognitive function using the CogState battery at 10-minute, one week and one month test-retest intervals. J Clin Exp Neuropsychol. 2006 Oct;28(7):1095-112. doi: 10.1080/13803390500205718.

  PMID: 16840238 BACKGROUND

• Tornatore JB, Hill E, Laboff JA, McGann ME. Self-administered screening for mild cognitive impairment: initial validation of a computerized test battery. J Neuropsychiatry Clin Neurosci. 2005 Winter;17(1):98-105. doi: 10.1176/jnp.17.1.98.

  PMID: 15746489 BACKGROUND

• Wild K, Howieson D, Webbe F, Seelye A, Kaye J. Status of computerized cognitive testing in aging: a systematic review. Alzheimers Dement. 2008 Nov;4(6):428-37. doi: 10.1016/j.jalz.2008.07.003.

  PMID: 19012868 BACKGROUND

• Elwood RW. MicroCog: assessment of cognitive functioning. Neuropsychol Rev. 2001 Jun;11(2):89-100. doi: 10.1023/a:1016671201211.

  PMID: 11572473 BACKGROUND

• Gualtieri CT, Johnson LG. Reliability and validity of a computerized neurocognitive test battery, CNS Vital Signs. Arch Clin Neuropsychol. 2006 Oct;21(7):623-43. doi: 10.1016/j.acn.2006.05.007. Epub 2006 Oct 2.

  PMID: 17014981 BACKGROUND

• Iverson GL, Brooks BL, Ashton VL, Johnson LG, Gualtieri CT. Does familiarity with computers affect computerized neuropsychological test performance? J Clin Exp Neuropsychol. 2009 Jul;31(5):594-604. doi: 10.1080/13803390802372125. Epub 2008 Oct 29.

  PMID: 18972312 BACKGROUND

• Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.

  PMID: 1202204 BACKGROUND

• Trzepacz PT, Mittal D, Torres R, Kanary K, Norton J, Jimerson N. Validation of the Delirium Rating Scale-revised-98: comparison with the delirium rating scale and the cognitive test for delirium. J Neuropsychiatry Clin Neurosci. 2001 Spring;13(2):229-42. doi: 10.1176/jnp.13.2.229.

  PMID: 11449030 BACKGROUND

• Fratiglioni L, Jorm AF, Grut M, Viitanen M, Holmen K, Ahlbom A, Winblad B. Predicting dementia from the Mini-Mental State Examination in an elderly population: the role of education. J Clin Epidemiol. 1993 Mar;46(3):281-7. doi: 10.1016/0895-4356(93)90076-d.

  PMID: 8455053 BACKGROUND

• Adamis D, Rooney S, Meagher D, Mulligan O, McCarthy G. A comparison of delirium diagnosis in elderly medical inpatients using the CAM, DRS-R98, DSM-IV and DSM-5 criteria. Int Psychogeriatr. 2015 Jun;27(6):883-9. doi: 10.1017/S1041610214002853. Epub 2015 Jan 20.

  PMID: 25601222 BACKGROUND

• Grover S, Kate N. Assessment scales for delirium: A review. World J Psychiatry. 2012 Aug 22;2(4):58-70. doi: 10.5498/wjp.v2.i4.58.

  PMID: 24175169 BACKGROUND

• Carvalho JP, de Almeida AR, Gusmao-Flores D. Delirium rating scales in critically ill patients: a systematic literature review. Rev Bras Ter Intensiva. 2013 Apr-Jun;25(2):148-54. doi: 10.5935/0103-507X.20130026.

  PMID: 23917980 BACKGROUND

• Koster S, Hensens AG, Oosterveld FG, Wijma A, van der Palen J. The delirium observation screening scale recognizes delirium early after cardiac surgery. Eur J Cardiovasc Nurs. 2009 Oct;8(4):309-14. doi: 10.1016/j.ejcnurse.2009.02.006. Epub 2009 Mar 12.

  PMID: 19285452 BACKGROUND

Related Links

• Delirium: diagnosis, prevention and management

MeSH Terms

Conditions

Emergence Delirium; Postoperative Cognitive Complications

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Cognitive Dysfunction; Cognition Disorders

Study Officials

• Nicolai Goettel, MD

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nicolai Goettel, MD

Study Record Dates

• First Submitted: February 14, 2015
• First Posted: March 3, 2015
• Study Start: March 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: April 1, 2016
• Last Updated: April 25, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)