Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06355570
Status:
RECRUITING
Last Update Posted:
2024-04-11
First Post:
2024-03-14
Brief Title:
Delirium After Cardiac Surgery in Intensive Care Units
Sponsor:
Imperial College Healthcare NHS Trust
Organization:
Imperial College Healthcare NHS Trust
Study Overview
Official Title:
The Use of Auditory-visual Stimulation to Reduce Delirium Rates in Intensive Care Patients Post-cardiac Surgery a Feasibility Study
Status:
RECRUITING
Status Verified Date:
2024-04
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:
DaCsi-ICU
Brief Summary:
STUDY SUMMARY
STUDY DESIGN The study will be conducted over twelve months in the Cardiac Intensive Care Unit ICU at Hammersmith Hospital Imperial College Healthcare NHS Trust ICHT This study is a mixed methods research design that includes the collection of data through qualitative interviews quality-of-life questionnaires and patients medical records
AIMS
Determine the incidence of ICU delirium in ICHT following cardiac surgery
Explore the compliance of outcome measures that diagnose ICU delirium
Implement a family-focused sensory stimulation programme in the ICU
Evaluate its useability and potential impact on patients families and ICU staff
STUDY POPULATION 30 study participants 12 patients 12 family membersfriends and 6 ICU nurses
ELIGIBILITY Study eligibility criteria are specific for each care group patients family membersfriends and ICU nurses
DURATION 12 months at Hammersmith Hospital ICHT
STUDY DESIGN The study will be conducted over twelve months in the Cardiac Intensive Care Unit ICU at Hammersmith Hospital Imperial College Healthcare NHS Trust ICHT This study is a mixed methods research design that includes the collection of data through qualitative interviews quality-of-life questionnaires and patients medical records
AIMS
Determine the incidence of ICU delirium in ICHT following cardiac surgery
Explore the compliance of outcome measures that diagnose ICU delirium
Implement a family-focused sensory stimulation programme in the ICU
Evaluate its useability and potential impact on patients families and ICU staff
STUDY POPULATION 30 study participants 12 patients 12 family membersfriends and 6 ICU nurses
ELIGIBILITY Study eligibility criteria are specific for each care group patients family membersfriends and ICU nurses
DURATION 12 months at Hammersmith Hospital ICHT
Detailed Description:
DaCsi-ICU is a mixed methods research study including the collection of data from patients medical notes interviews and quality of life questionnaires following the study schedule of assessments This study also involves the implementation of an auditory-visual sensory stimulation package in the cardiac ICU at ICHT to participants enrolled in the study
Digital photos will be shown continuously at the patients bedside 8am-8pm after cardiac surgery and will always have reference to time and date Additionally videos will be played throughout the patients stay in the ICU at least three times per day timepoints 9am 2pm7pm and upon participant request Videos will be also played when participants show signs of ICU delirium to reduce its incidence and improve overall health outcomes Simultaneously data from patients medical records will be routinely collected by the research team eg Confusion Assessment Method-ICU Richmond Agitation Sedation Scale etc to assess whether patients develop delirium during their stay in the ICU
Interviews with patients and familiesfriends will be held on three different occasions The first one will be on the same day as ICU discharge the second interview will be on the day of hospital discharge and the third one will be carried out up to a month following hospital discharge during their clinical follow-up appointment Where possible family membersfriends and patient interviews will be conducted together dyadic interviewing but the possibility of performing interviews separately will be given so that participants feel able to discuss opinions freely Nurses interviews will be held as a one-off and after they have provided direct care to participants who received the proposed intervention
Each patient will be followed up daily on the wards and once at the monthly follow-up clinic after ICU discharge where cognitive and emotional assessments will be performed to evaluate delirium outcomes The research team will also collect relevant information from participants medical notes if any complications post-ICU discharge arise during inpatient and follow-up stages
Digital photos will be shown continuously at the patients bedside 8am-8pm after cardiac surgery and will always have reference to time and date Additionally videos will be played throughout the patients stay in the ICU at least three times per day timepoints 9am 2pm7pm and upon participant request Videos will be also played when participants show signs of ICU delirium to reduce its incidence and improve overall health outcomes Simultaneously data from patients medical records will be routinely collected by the research team eg Confusion Assessment Method-ICU Richmond Agitation Sedation Scale etc to assess whether patients develop delirium during their stay in the ICU
Interviews with patients and familiesfriends will be held on three different occasions The first one will be on the same day as ICU discharge the second interview will be on the day of hospital discharge and the third one will be carried out up to a month following hospital discharge during their clinical follow-up appointment Where possible family membersfriends and patient interviews will be conducted together dyadic interviewing but the possibility of performing interviews separately will be given so that participants feel able to discuss opinions freely Nurses interviews will be held as a one-off and after they have provided direct care to participants who received the proposed intervention
Each patient will be followed up daily on the wards and once at the monthly follow-up clinic after ICU discharge where cognitive and emotional assessments will be performed to evaluate delirium outcomes The research team will also collect relevant information from participants medical notes if any complications post-ICU discharge arise during inpatient and follow-up stages
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RFPR2324_29 | OTHER_GRANT | None | None |
| 24YH0011 | OTHER | UK Health Research Authority Research Ethics Committee | None |