Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06172491
Status:
RECRUITING
Last Update Posted:
2024-04-01
First Post:
2023-12-07
Brief Title:
Automating Delirium Severity in the ICU
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Harnessing the Power of Technology to Transform Delirium Severity Measurement in the ICU
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ADS-ICU
Brief Summary:
The goal of this observational study is to develop a passive digital marker PDM for delirium severity and examine its performance in comparison to validated delirium severity tools in ICU patients 50 years of age
The main questions it aims to answer are
Is the trained convolutional neural network able to reliably measure delirium severity
Is the Passive Digital Marker able to accurately measure delirium severity
Is the Passive Digital Marker acceptable and usable by frontline ICU nurse clinicians patients and their identified proxies ie caregivers
Participants will
Study participation involves a video camera recording you 24 hours per day while you are a patient in the Intensive Care Unit ICU
Study staff will visit you 4 times each day you are in the ICU You will be asked questions each time they visit to train the digital marker and see differences between assessments and camera data
The main questions it aims to answer are
Is the trained convolutional neural network able to reliably measure delirium severity
Is the Passive Digital Marker able to accurately measure delirium severity
Is the Passive Digital Marker acceptable and usable by frontline ICU nurse clinicians patients and their identified proxies ie caregivers
Participants will
Study participation involves a video camera recording you 24 hours per day while you are a patient in the Intensive Care Unit ICU
Study staff will visit you 4 times each day you are in the ICU You will be asked questions each time they visit to train the digital marker and see differences between assessments and camera data
Detailed Description:
Bedside cameras will stay up for at least 72 hours about 3 days it may be longer if delirium is being experienced and if the patient and or LAR Legally Authorized Representative agree to the cameras continued recording
The study team will come and ask the patient questions 4 times daily We will ask questions about their general mental and emotional health their mood and memory During these visits the study team will check the alertness of the patient Alertness will be checked by voice if they do not respond we will tap their shoulder gently We will ask the patient to do activities like remembering words and saying them back shaking hands and drawing an object or clock The study team will administer assessments 4 times daily Participants will be asked questions about their general mental and emotional health as well as mood and memory While performing these sessions the study team will observe the level of awareness Awareness will be assessed by voice if they do not respond we will have to do a gentle tap on their shoulders The patient will be asked to perform activities such as remembering words and repeating them back handshaking and drawing an object or clock
In some cases if the patients level of awareness alertness is lowered we will do observation only perform observation assessments These assessments do not interfere with clinical care Participation in this study is voluntary
The study team will continue to follow the patient until discharged from ICU
The bedside nurse patient or family can cover the cameras with a washcloth if needed for privacy The faces of family and clinicians and the bathing suit areas of patients are blurred before analysis to protect privacy
The study team will come and ask the patient questions 4 times daily We will ask questions about their general mental and emotional health their mood and memory During these visits the study team will check the alertness of the patient Alertness will be checked by voice if they do not respond we will tap their shoulder gently We will ask the patient to do activities like remembering words and saying them back shaking hands and drawing an object or clock The study team will administer assessments 4 times daily Participants will be asked questions about their general mental and emotional health as well as mood and memory While performing these sessions the study team will observe the level of awareness Awareness will be assessed by voice if they do not respond we will have to do a gentle tap on their shoulders The patient will be asked to perform activities such as remembering words and repeating them back handshaking and drawing an object or clock
In some cases if the patients level of awareness alertness is lowered we will do observation only perform observation assessments These assessments do not interfere with clinical care Participation in this study is voluntary
The study team will continue to follow the patient until discharged from ICU
The bedside nurse patient or family can cover the cameras with a washcloth if needed for privacy The faces of family and clinicians and the bathing suit areas of patients are blurred before analysis to protect privacy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None