Predicting Delirium by Attentional Dysfunction

NCT03988179 | Completed

• 1 other identifier: NL47720.018.014
• Study Type: observational
• Target: 172
• Locations: 0 countries
• Sites: N/A

Brief Summary

Rationale: Delirium is a common complication that occurs in various medical conditions. Validated models predicting delirium in individual patients are scarce and existing models tend to focus on demographic characteristics and comorbid conditions exclusively. Previous research has suggested that impairment of attentional function might serve as an early and specific individual predictor of incident delirium. Utilization of a test measuring attentional function in a clinically easy-to-use tool could potentially yield a pathophysiological monitor to identify individual patients at risk of evolving delirium and target future prophylactic treatment. Objective: To assess the difference in preoperative intra-individual reaction time variability between postoperative delirium and non-delirium elderly non-dementia patients undergoing elective surgery. Study design: An observational prospective cohort study. Study population: Elderly patients (70 years or older) undergoing elective surgery. Main study parameters/endpoints: Preoperative intra-individual reaction time variability among postoperative non-delirium and delirium patients.

Conditions

Delirium in Old Age

Keywords

Attention; Attentional dysfunction; Delirium; Preoperative

Outcome Measures

Primary Outcomes (1)

• Preoperative intra-individual reaction time variability.

  To assess the difference in preoperative intra-individual reaction time variability between postoperative delirium and non-delirium elderly non-dementia patients undergoing elective surgery.

  02-2014 / 06-2015

Secondary Outcomes (4)

• Preoperative individual accuracy of reaction time response.

  02-2014 / 06-2015

• Association between intra-individual reaction time variability on the ChIP application for iPad and development of delirium, defined as a positive score on the CAM on any given moment during the first 5 days postoperatively.

  02-2014 / 06-2015

• Association between accuracy of reaction time response on the ChIP application for iPad and delirium, defined as a positive score on the CAM on any given moment during the first 5 days postoperatively.

  02-2014 / 06-2015

• Sensitivity and specificity of a combined index of preoperative intra-individual reaction time variability and accuracy of response in predicting delirium.

  02-2014 / 06-2015

Interventions

The Cholinesterase Inhibitor Prognosticator (ChIP) application for iPad DIAGNOSTIC_TEST

The first part of this application will be used, consisting of a visual vigilance test based on the Continuous Performance Test (CPT). Stimuli consist of a one digit number presented in the middle of the screen. For each trial the application randomly selects a specific number as the target stimulus. Patients are instructed to keep their dominant trigger finger close to the screen and press a button which is located at the bottom of the screen, whenever the target appears. In case another stimulus appears the patient is instructed to do nothing. Each stimulus is presented until the patient presses the button (maximum 3 sec.). Stimuli are presented in a random fashion with a 1, 2, 3, 4, or 5 second inter-stimuli-interval blank, which randomly varies. After an 8 stimuli practice trial, the test starts and a total of 50 stimuli are presented with a 50% target rate. Full-trial duration is approximately 5 minutes. During the trial, reaction time and accuracy of response are registered.

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Elderly non-dementia patients undergoing major elective surgery.

You may qualify if:

• Age 70 years or older
• Elective surgery involving thoracotomy, major abdominal surgery (e.g. esophageal, gastric, hepatic, pancreatic, colorectal resection by either laparotomy or laparoscopic approach), major pelvic surgery (e.g. radical cystectomy, radical hysterectomy), or major orthopedic surgery (e.g. knee or hip replacement)

You may not qualify if:

• Preceding diagnosis of dementia or Clinical Dementia Rating (CDR) scale of 1 or more
• Language barrier enough to hamper informed consent and iPad instructions
• Serious functional disability of the dominant hand (e.g. palsy, amputation, arthrodesis)

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• W. A. van Gool, MD, PhD

  Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr. W.A. van Gool, MD, PhD

Study Record Dates

• First Submitted: June 11, 2019
• First Posted: June 17, 2019
• Study Start: April 4, 2014
• Primary Completion: May 15, 2015
• Study Completion: May 23, 2015
• Last Updated: June 17, 2019

Record last verified: 2019-06