DeliriumCONfuSEDNCT04589169
Non-Invasive Eye Tracking for the Diagnosis of Delirium on ICU
An observational study of Delirium, run by Chelsea and Westminster NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
In this trial, the investigators seek to demonstrate the feasibility of a system in continuously detecting 'inattention' as a subset of CAM-ICU in a small representative sample of patients in the Intensive Care Unit (ICU) at Chelsea \& Westminster NHS Foundation Trust. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Dec 2020to 12 Oct 2021
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Adult inpatients in ICU
Who may be able to join
- Aged >18
- Predicted Delirium as defined by the Early PREdiction of DELIRium in ICU patients (E-PREDELIRIC) score ≥ 20%
- Expected length of stay ≥ 2 days
Who cannot join
- Non-concordant eyes
- Visual Impairment
- Dementia
- Inability for facial recognition and eye tracking to be performed reliably
- Lack of signed consent form / nominated consultee form
- In-ability to perform CAM-ICU reliably
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Chelsea and Westminster Hospital NHS Foundation Trust
London, SW10 9NH
Research Delivery Operations Manager, 020 3315 6825, research.development@chelwest.nhs.uk
Marcela Vizcaychipi, MD, PhD, 02033158024, Marcela.Vizcaychipi@chelwest.nhs.uk
About this study
Official title: Continuous Non-Invasive Eye Tracking for the Early Detection of Delirium on the Intensive Care Unit
In this trial, the investigators seek to demonstrate the feasibility of a system in continuously detecting 'inattention' as a subset of CAM-ICU in a small representative sample of patients in the Intensive Care Unit (ICU) at Chelsea \& Westminster NHS Foundation Trust.
Read the detailed description
Delirium is an acute confusional state that affects many patients admitted to the hospital, especially intensive care. The current diagnosis of delirium is through the use of the Confusional Assessment Method in Intensive Care Unit (CAM-ICU) task based questionnaire. The core prinicipal to CAM-ICU is inattention; this is tested through asking the patient to remember a task and execute it on demand, e.g. squeezing the operator's hand everytime the letter A is said and then spelling CASABLANCA.
The aim of this study is to find correlates to inattention. Eye-gaze data is ideally suited for this task as eyes move to pay attention to the environment.
A video camera based eye-tracker has been developed that sits at the end of the bed (head-camera) and another behind the patient (scene-camera). The head-camera uses machine learning to measure the gaze of the patient's eyes while the scene-camera finds what the patient is looking at. Simulations are then run from the scene camera and the patient's gaze is then compared to find whether the patient is paying attention to what is simulated.
Once per day, a member of the local research team will fill in a non-validated questionnaire based on work by MacMurchy et al.
- MacMurchy, S. Stemler, M. Zander, C. P. Bonafide, Acceptability, Feasibility, and Cost of Using Video to Evaluate Alarm Fatigue, Biomedical Instrumentation \& Technology 51 (2017) 25-33.
- Conditions
- Delirium
- Keywords
- Delirium, Inattention, Eye-gaze, ICU
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Positive cohort | Patients who develop delirium | |
| Experimental control group | Patients who do not develop delirium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate eye gaze correlates with CAM-ICU
Patient's usual clinical care will not be affected by the assessments performed by this study. In our institution, CAM-ICU is performed at least twice daily and more so if there are changes to mental status. The system will be switched on 5 minutes prior to performing CAM-ICU and will record for a duration of 10 minutes following which, the system will be turned off and the cameras covered. This procedure will occur every time CAM-ICU is performed.
Measured: 8-12 months
Secondary outcomes (1)
Acceptance of the use of cameras and artificial intelligence on ICU
Once per day, the research staff will complete an acceptability questionnaire designed to ascertain the acceptability of the use of cameras within this study on day to day activities in ICU.This questionnaire is based on work by MacMurchy et al.
- Minimum value is 0, maximum value is 4.
- Higher scores indicate that the system affected the nurse's ability to communicate with patients, nurses and doctors and that it affected the nurse's ability to care for them.
- A yes answer = 1 point, a No answer = 0 points. Marking will be done per question to gain insights into how the system affected the nurses.
Measured: 8-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start7 Dec 2020
- Primary completion12 Oct 2021 (estimated)
- Study completion12 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chelsea and Westminster NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Westminster Medical School Research Trust, BMA Foundation for Medical Research
- Responsible party
- Sponsor
- Investigators
- Ahmed Al-Hindawi, BMBS, MRCA, Principal investigator, Chelsea and Westminster NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04589169
- Sponsor's protocol ID
- C&W19/064
- Other IDs
- IRAS number 264759
- Acronym
- CONfuSED
- Status last verified
- Dec 2020
- First submitted
- 9 Oct 2020
- Last updated
- 8 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McCusker J, Cole M, Abrahamowicz M, Primeau F, Belzile E. Delirium predicts 12-month mortality. Arch Intern Med. 2002 Feb 25;162(4):457-63. doi: 10.1001/archinte.162.4.457.
PubMed 11863480Miotto R, Li L, Kidd BA, Dudley JT. Deep Patient: An Unsupervised Representation to Predict the Future of Patients from the Electronic Health Records. Sci Rep. 2016 May 17;6:26094. doi: 10.1038/srep26094.
PubMed 27185194M. Sarabia, Y. Demiris, A Humanoid Robot Companion for Wheelchair Users, Social Robotics 8239 (2013) 432-441.
A. P. A. A. P. Association, et al., DSM-IV-TR: Diagnostic and Statistical Manual of Mental Disorders, Wash ington, DC: American psychiatric association (1994) 143-147.
Holt-Lunstad J, Smith TB, Layton JB. Social relationships and mortality risk: a meta-analytic review. PLoS Med. 2010 Jul 27;7(7):e1000316. doi: 10.1371/journal.pmed.1000316.
PubMed 20668659Palmu R, Suominen K, Vuola J, Isometsa E. Mental disorders among acute burn patients. Burns. 2010 Nov;36(7):1072-9. doi: 10.1016/j.burns.2010.04.004. Epub 2010 May 18.
PubMed 20483541Lundstrom M, Olofsson B, Stenvall M, Karlsson S, Nyberg L, Englund U, Borssen B, Svensson O, Gustafson Y. Postoperative delirium in old patients with femoral neck fracture: a randomized intervention study. Aging Clin Exp Res. 2007 Jun;19(3):178-86. doi: 10.1007/BF03324687.
PubMed 17607084Meier-Ruge W, Hunziker O, Iwangoff P. Senile dementia: a threshold phenomenon of normal aging? A contribution to the functional reserve hypothesis of the brain. Ann N Y Acad Sci. 1991;621:104-18. doi: 10.1111/j.1749-6632.1991.tb16973.x.
PubMed 1907117Meagher DJ. Delirium: optimising management. BMJ. 2001 Jan 20;322(7279):144-9. doi: 10.1136/bmj.322.7279.144. No abstract available.
PubMed 11159573Lin SM, Liu CY, Wang CH, Lin HC, Huang CD, Huang PY, Fang YF, Shieh MH, Kuo HP. The impact of delirium on the survival of mechanically ventilated patients. Crit Care Med. 2004 Nov;32(11):2254-9. doi: 10.1097/01.ccm.0000145587.16421.bb.
PubMed 15640638Ouimet S, Kavanagh BP, Gottfried SB, Skrobik Y. Incidence, risk factors and consequences of ICU delirium. Intensive Care Med. 2007 Jan;33(1):66-73. doi: 10.1007/s00134-006-0399-8. Epub 2006 Nov 11.
PubMed 17102966Pisani MA, Araujo KL, Van Ness PH, Zhang Y, Ely EW, Inouye SK. A research algorithm to improve detection of delirium in the intensive care unit. Crit Care. 2006;10(4):R121. doi: 10.1186/cc5027.
PubMed 16919169Beedie SA, Benson PJ, St Clair DM. Atypical scanpaths in schizophrenia: evidence of a trait- or state-dependent phenomenon? J Psychiatry Neurosci. 2011 May;36(3):150-64. doi: 10.1503/jpn.090169.
PubMed 21223647Loughland CM, Williams LM, Gordon E. Schizophrenia and affective disorder show different visual scanning behavior for faces: a trait versus state-based distinction? Biol Psychiatry. 2002 Aug 15;52(4):338-48. doi: 10.1016/s0006-3223(02)01356-2.
PubMed 12208641Trillenberg P, Lencer R, Heide W. Eye movements and psychiatric disease. Curr Opin Neurol. 2004 Feb;17(1):43-7. doi: 10.1097/00019052-200402000-00008.
PubMed 15090876
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Non-Invasive Eye Tracking for the Early Detection of Delirium on the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT04589169
- Acronym / sponsor ID
- CONfuSED / C&W19/064
- Conditions
- Delirium
- Keywords
- Delirium, Inattention, Eye-gaze, ICU
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chelsea and Westminster NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Westminster Medical School Research Trust, BMA Foundation for Medical Research
- Study start
- 7 Dec 2020 (actual)
- Primary completion
- 12 Oct 2021 (estimated)
- Study completion
- 12 Oct 2021 (estimated)
- First posted
- 19 Oct 2020 (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.
In this trial, the investigators seek to demonstrate the feasibility of a system in continuously detecting 'inattention' as a subset of CAM-ICU in a small representative sample of patients in the Intensive Care Unit (ICU) at Chelsea \& Westminster NHS Foundation Trust.
Detailed description
Delirium is an acute confusional state that affects many patients admitted to the hospital, especially intensive care. The current diagnosis of delirium is through the use of the Confusional Assessment Method in Intensive Care Unit (CAM-ICU) task based questionnaire. The core prinicipal to CAM-ICU is inattention; this is tested through asking the patient to remember a task and execute it on demand, e.g. squeezing the operator's hand everytime the letter A is said and then spelling CASABLANCA.
The aim of this study is to find correlates to inattention. Eye-gaze data is ideally suited for this task as eyes move to pay attention to the environment.
A video camera based eye-tracker has been developed that sits at the end of the bed (head-camera) and another behind the patient (scene-camera). The head-camera uses machine learning to measure the gaze of the patient's eyes while the scene-camera finds what the patient is looking at. Simulations are then run from the scene camera and the patient's gaze is then compared to find whether the patient is paying attention to what is simulated.
Once per day, a member of the local research team will fill in a non-validated questionnaire based on work by MacMurchy et al.
- MacMurchy, S. Stemler, M. Zander, C. P. Bonafide, Acceptability, Feasibility, and Cost of Using Video to Evaluate Alarm Fatigue, Biomedical Instrumentation \& Technology 51 (2017) 25-33.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive cohort | – | –Patients who develop delirium |
| Experimental control group | – | –Patients who do not develop delirium |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult inpatients in ICU
Key inclusion criteria (3 listed)
- Aged >18
- Predicted Delirium as defined by the Early PREdiction of DELIRium in ICU patients (E-PREDELIRIC) score ≥ 20%
- Expected length of stay ≥ 2 days
Key exclusion criteria (6 listed)
- Non-concordant eyes
- Visual Impairment
- Dementia
- Inability for facial recognition and eye tracking to be performed reliably
- Lack of signed consent form / nominated consultee form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Demonstrate eye gaze correlates with CAM-ICU
Time frame: 8-12 months
Patient's usual clinical care will not be affected by the assessments performed by this study. In our institution, CAM-ICU is performed at least twice daily and more so if there are changes to mental status. The system will be switched on 5 minutes prior to performing CAM-ICU and will record for a duration of 10 minutes following which, the system will be turned off and the cameras covered. This procedure will occur every time CAM-ICU is performed.
1 secondary outcome
Acceptance of the use of cameras and artificial intelligence on ICU
Time frame: 8-12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2020.
- Background: PubMed 11863480McCusker J, Cole M, Abrahamowicz M, Primeau F, Belzile E. Delirium predicts 12-month mortality. Arch Intern Med. 2002 Feb 25;162(4):457-63. doi: 10.1001/archinte.162.4.457.
- Background: PubMed 27185194Miotto R, Li L, Kidd BA, Dudley JT. Deep Patient: An Unsupervised Representation to Predict the Future of Patients from the Electronic Health Records. Sci Rep. 2016 May 17;6:26094. doi: 10.1038/srep26094.
- BackgroundM. Sarabia, Y. Demiris, A Humanoid Robot Companion for Wheelchair Users, Social Robotics 8239 (2013) 432-441.
- BackgroundA. P. A. A. P. Association, et al., DSM-IV-TR: Diagnostic and Statistical Manual of Mental Disorders, Wash ington, DC: American psychiatric association (1994) 143-147.
- Background: PubMed 20668659Holt-Lunstad J, Smith TB, Layton JB. Social relationships and mortality risk: a meta-analytic review. PLoS Med. 2010 Jul 27;7(7):e1000316. doi: 10.1371/journal.pmed.1000316.
- Background: PubMed 20483541Palmu R, Suominen K, Vuola J, Isometsa E. Mental disorders among acute burn patients. Burns. 2010 Nov;36(7):1072-9. doi: 10.1016/j.burns.2010.04.004. Epub 2010 May 18.
- Background: PubMed 17607084Lundstrom M, Olofsson B, Stenvall M, Karlsson S, Nyberg L, Englund U, Borssen B, Svensson O, Gustafson Y. Postoperative delirium in old patients with femoral neck fracture: a randomized intervention study. Aging Clin Exp Res. 2007 Jun;19(3):178-86. doi: 10.1007/BF03324687.
- Background: PubMed 1907117Meier-Ruge W, Hunziker O, Iwangoff P. Senile dementia: a threshold phenomenon of normal aging? A contribution to the functional reserve hypothesis of the brain. Ann N Y Acad Sci. 1991;621:104-18. doi: 10.1111/j.1749-6632.1991.tb16973.x.
- Background: PubMed 11159573Meagher DJ. Delirium: optimising management. BMJ. 2001 Jan 20;322(7279):144-9. doi: 10.1136/bmj.322.7279.144. No abstract available.
- Background: PubMed 15640638Lin SM, Liu CY, Wang CH, Lin HC, Huang CD, Huang PY, Fang YF, Shieh MH, Kuo HP. The impact of delirium on the survival of mechanically ventilated patients. Crit Care Med. 2004 Nov;32(11):2254-9. doi: 10.1097/01.ccm.0000145587.16421.bb.
- Background: PubMed 17102966Ouimet S, Kavanagh BP, Gottfried SB, Skrobik Y. Incidence, risk factors and consequences of ICU delirium. Intensive Care Med. 2007 Jan;33(1):66-73. doi: 10.1007/s00134-006-0399-8. Epub 2006 Nov 11.
- Background: PubMed 16919169Pisani MA, Araujo KL, Van Ness PH, Zhang Y, Ely EW, Inouye SK. A research algorithm to improve detection of delirium in the intensive care unit. Crit Care. 2006;10(4):R121. doi: 10.1186/cc5027.
- Individual participant dataSharing planned: No
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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.
Ahmed Al-Hindawi, BMBS, MRCA principal investigator
Chelsea and Westminster NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium, run by Chelsea and Westminster NHS Foundation Trust at 1 site in United Kingdom.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 8 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Research Delivery Operations Manager (020 3315 6825, research.development@chelwest.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demonstrate eye gaze correlates with CAM-ICU (time frame: 8-12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04589169, which also lists 20 linked publications.
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 8 Dec 2020.