Delirium in Old AgeRAPIDNCT03988179
Predicting Delirium by Attentional Dysfunction
An observational study of Delirium in Old Age, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Delirium in Old Age
- What is being tested?
- The Cholinesterase Inhibitor Prognosticator (ChIP) application for iPad
- How many people
- 172 participants
- Where
- No sites listed yet
- Study dates
- 4 Apr 2014to 23 May 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- Older adult
Study population: Elderly non-dementia patients undergoing major elective surgery.
Who may be able to join
- 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)
Who cannot join
- 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)
About this study
Official title: Registration of Attentional Function as a Predictor of Incident Delirium
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.
Read more
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.
Read the 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.
- Conditions
- Delirium in Old Age
- Being tested
- The Cholinesterase Inhibitor Prognosticator (ChIP) application for iPad
- Keywords
- Attention, Attentional dysfunction, Delirium, Preoperative
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Cholinesterase Inhibitor Prognosticator (ChIP) application for iPadDiagnostic 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 02-2014 / 06-2015
Secondary outcomes (4)
Preoperative individual accuracy of reaction time response.
To assess the difference in preoperative accuracy of response on a reaction time test between postoperative delirium and non-delirium elderly non-dementia patients undergoing elective surgery.
Measured: 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.
For each subject preoperative intra-individual reaction time variability will be determined using the standard deviation (SD) of individual preoperative reaction times (continuous variable). To determine the association between preoperative intra-individual reaction time variability and development of postoperative delirium odds ratios (OR) along with 95% confidence intervals (CI) will be calculated using multivariate logistic regression. A cut-off will be made at 1 SD above total group mean average for scores on intra-individual reaction time. Presence of delirium will be defined as a positive score on the CAM on any given moment during the first 5 days postoperatively.
Measured: 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.
For each subject preoperative individual accuracy of reaction time response will be determined by the total of target stimuli missed (continuous variable). To determine the association between individual accuracy of response and development of postoperative delirium odds ratios (OR) along with 95% confidence intervals (CI) will be calculated using multivariate logistic regression. A cut-off will be made at 1 SD above total group mean average for scores on individual accuracy of response. Presence of delirium will be defined as a positive score on the CAM on any given moment during the first 5 days postoperatively.
Measured: 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.
To determine the sensitivity and specificity of a combined index of preoperative reaction time variability and accuracy of response in predicting postoperative delirium among elderly non-dementia patients undergoing elective surgery.
Measured: 02-2014 / 06-2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2019
- Study start4 Apr 2014
- Primary completion15 May 2015
- Study completion23 May 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delirium in Old AgeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Principal investigator, W ten Hoope, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- W. A. van Gool, MD, PhD, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03988179
- Sponsor's protocol ID
- NL47720.018.014
- Acronym
- RAPID
- Status last verified
- Jun 2019
- First submitted
- 11 Jun 2019
- Last updated
- 17 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registration of Attentional Function as a Predictor of Incident Delirium
- ClinicalTrials.gov ID
- NCT03988179
- Acronym / sponsor ID
- RAPID / NL47720.018.014
- Conditions
- Delirium in Old Age
- Keywords
- Attention, Attentional dysfunction, Delirium, Preoperative
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- 4 Apr 2014 (actual)
- Primary completion
- 15 May 2015 (actual)
- Study completion
- 23 May 2015 (actual)
- First posted
- 17 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- Elderly non-dementia patients undergoing major elective surgery.
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Cholinesterase Inhibitor Prognosticator (ChIP) application for iPadThe 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. | Diagnostic test | – |
Primary outcome
Preoperative intra-individual reaction time variability.
Time frame: 02-2014 / 06-2015
To assess the difference in preoperative intra-individual reaction time variability between postoperative delirium and non-delirium elderly non-dementia patients undergoing elective surgery.
4 secondary outcomes
Preoperative individual accuracy of reaction time response.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 02-2014 / 06-2015
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
W. A. van Gool, MD, PhD principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium in Old Age, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative intra-individual reaction time variability. (time frame: 02-2014 / 06-2015). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2019.