Delirium After Cardiac Surgery in Intensive Care Units

NCT06355570 | Recruiting

• 3 other identifiers: 331314RFPR2324_2924/YH/0011
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 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

Conditions

Intensive Care Unit Delirium; Cardiac Surgery; Post Operative Delirium

Outcome Measures

Primary Outcomes (1)

• Feasibility of implementing the study intervention

  The investigators plan to implement a family-focused auditory-visual sensory stimulation intervention to reduce ICU delirium rates post-cardiac surgery. Feasibility will be assessed by exploring facilitator factors and challenges that may arise during the implementation of this intervention. These elements will be recorded on a study reflective log and further discussed within the study team.

  12 months

Secondary Outcomes (3)

• Practicalities of introducing the study intervention

  12 months

• Acceptability of implementing the study intervention

  12 months

• Short-term delirium outcomes post-ICU discharge

  12 months

Study Arms (1)

Patient Arm

EXPERIMENTAL

12 patients will be recruited pre-operatively and submitted to the study intervention

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

Interventions

Personal Pictures OTHER

Digital photos will be shown continuously at the patient's bedside for 12 hours a day (between 8 am to 8 pm).

Patient Arm

Family Videos OTHER

Family-recorded videos will be played three times at specific hours of the day - 9 am, 2 pm and 7 pm - throughout patient stay in the ICU

Patient Arm

Family Videos - Intervention as required OTHER

The last video shown will be re-played upon patient request and/or if patients develop ICU delirium.

Patient Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College Healthcare NHS Trust: lead

Study Sites (1)

Imperial College Healthcare NHS Trust

London, W12 0HS, United Kingdom

RECRUITING

Related Publications (1)

• De Azinheira Reguenga MJ, Lampridou S, Pattison N, Brett SJ, Soni S. The use of audio-visual aids to reduce delirium after cardiac surgery in intensive care units (DaCSi-ICU): A feasibility study protocol. PLoS One. 2025 Apr 24;20(4):e0320935. doi: 10.1371/journal.pone.0320935. eCollection 2025.

  PMID: 40273276 DERIVED

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Maria Reguenga, BSN

  Imperial College Healthcare NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Reguenga, BSN

CONTACT

07585095566; maria.reguenga@nhs.net

Sanooj Soni, PhD

CONTACT

07714329708; sanooj.soni@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 12-patient participants will be submitted to the study intervention.

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: April 9, 2024
• Study Start: March 20, 2024
• Primary Completion: December 31, 2024
• Study Completion: March 20, 2025
• Last Updated: April 11, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)