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Delirium After Cardiac Surgery in Intensive Care Units (DaCsi-ICU)

I

Imperial College Healthcare NHS Trust

Status

Enrolling

Conditions

Cardiac Surgery
Post Operative Delirium
Intensive Care Unit Delirium

Treatments

Other: Personal Pictures
Other: Family Videos
Other: Family Videos - Intervention as required

Study type

Interventional

Funder types

Other

Identifiers

NCT06355570
RFPR2324_29 (Other Grant/Funding Number)
24/YH/0011 (Other Identifier)
331314

Details and patient eligibility

About

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 members/friends and 6 ICU nurses)

ELIGIBILITY Study eligibility criteria are specific for each care group (patients, family members/friends and ICU nurses).

DURATION 12 months at Hammersmith Hospital, ICHT

Full description

DaCsi-ICU is a mixed methods research study including the collection of data from patient's 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 patient's bedside (8am-8pm) after cardiac surgery and will always have reference to time and date. Additionally, videos will be played throughout the patient's stay in the ICU at least three times per day (timepoints: 9am, 2pm,7pm) 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 (e.g., 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 families/friends 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 members/friends 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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

INCLUSION CRITERIA

Patients

  • Female and male patients over the age of 18
  • Participants speaking English language and having mental capacity to consent
  • Suitable to undergoing cardiac surgery at ICHT.

Family Members/Friends

  • Nominated by the participant.
  • Be willing to record videos and participate in the study.

Healthcare professionals

  • Critical Care Nurses that have provided direct care to at least one patient who received the study intervention

EXCLUSION CRITERIA

Patients

  • Female and male patients under the age of 18
  • Unable to consent to the study pre-operatively
  • Significant hearing/visual impairment
  • Participants with learning disabilities, pre-existing delirium, dementia or other significant underlying cognitive morbidity
  • Moribund participants, likely to die in the next 24 hours
  • Participants that do not speak English language

Family Members/Friends

  • Refuse to consent or gain assent
  • Significant hearing/visual impairment
  • Family members/friends that do not speak English language

Healthcare professionals

  • Critical care nurses that have not been involved in the implementation of the intervention
  • Refuse to consent or gain assent
  • Significant hearing/visual impairment and non-English speaking

WITHDRAWAL CRITERIA:

Participants

  • No longer willing to participate after consent
  • Personal consultee wishing to withdraw participants from the study
  • Patients that the clinical and/or research team deem too distressed to continue participating in the study
  • Patients who have lost the capacity to participate in the study after hospital discharge

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

Patient Arm
Experimental group
Description:
12 patients will be recruited pre-operatively and submitted to the study intervention
Treatment:
Other: Personal Pictures
Other: Family Videos - Intervention as required
Other: Family Videos

Trial contacts and locations

1

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Central trial contact

Sanooj Soni, PhD; Maria Reguenga, BSN

Data sourced from clinicaltrials.gov

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