Clinical trial NCT03988179: Predicting Delirium by Attentional Dysfunction
Official title: Registration of Attentional Function as a Predictor of Incident Delirium
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium in Old Age
Keywords: Attention
Attentional dysfunction
Delirium
Preoperative
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2019-06-17
Enrollment: 172
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Elderly non-dementia patients undergoing major elective surgery.

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.

Detailed description: Delirium is a common complication that occurs in various medical conditions. Development of delirium during admission is associated with an increase in length of hospital stay, complication rates, mortality and consequently higher healthcare expenditures. Besides these short-term consequences, delirium is detrimental to long-term outcome with an ensuing higher risk of dementia, institutionalization and death.

Development of delirium is associated with increasing age. The risk for postoperative delirium among elderly patients ranges from 4%-53%. Incidence differs between different surgical procedures and between emergency or elective surgery. A systematic review comparing general to regional anaesthetic procedures did not show significant differences in the risk for developing postoperative delirium.

Although an array of risk factors associated with development of delirium has been identified in numerous studies, validated models predicting delirium in individual patients are scarce.

Moreover, existing models tend to focus on demographic characteristics and comorbid conditions exclusively. Models predicting development of delirium by using individual pathophysiological markers involved in the evolution of delirium are absent.

Previous research has suggested that impairment of attentional function might serve as an early and specific individual predictor of incident delirium, even in previously cognitively undisturbed patients. So far only one study has prospectively assessed preoperative intra-individual reaction time variability as a predictor of postoperative delirium. This study was limited to elderly (age 70 years or older) patients undergoing elective hip and knee replacement and did not examine confounding factors such as preoperative use of (anti-cholinergic) drugs, preoperative presence of symptoms of depression, cognitive decline or impairment in activities of daily living making. Although this study showed significant higher preoperative intra-individual reaction time variability among patients developing postoperative delirium, no attempts to reproduce these findings in other surgical populations have been published to date, limiting external validity and practical implementation of these observations.

The investigators hypothesize that preoperative intra-individual reaction-time variability is an independent predictor of postoperative delirium. In this study the investigators aim at assessing the potential of preoperative administration of a short test of attentional function in predicting postoperative delirium in a population of elderly non-dementia patients undergoing major elective surgery. Utilization of a test measuring attentional function in a clinically easy-to-use tool could potentially yield a pathophysiological monitor to preoperatively identify individual patients undergoing elective surgery who are at an increased risk of evolving delirium and create a target for future prophylactic treatment.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Preoperative intra-individual reaction time variability.
timeFrame: 02-2014 / 06-2015
Secondary outcomes:
measure: Preoperative individual accuracy of reaction time response.
timeFrame: 02-2014 / 06-2015
measure: 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.
timeFrame: 02-2014 / 06-2015
measure: 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.
timeFrame: 02-2014 / 06-2015
measure: Sensitivity and specificity of a combined index of preoperative intra-individual reaction time variability and accuracy of response in predicting delirium.
timeFrame: 02-2014 / 06-2015
Other outcomes:
Locations:
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: W. A. van Gool, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: