Delirium After Cardiac Surgery in Intensive Care Units — DaCsi-ICU  

Cardiac Surgery Clinical Trial

Official title: The Use of Auditory-visual Stimulation to Reduce Delirium Rates in Intensive Care Patients Post-cardiac Surgery: a Feasibility Study

Status Recruiting

Clinical Trial 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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Cardiac Surgery
• Delirium
• Emergence Delirium
• Intensive Care Unit Delirium
• Post Operative Delirium

• NCT number: NCT06355570
• Study type: Interventional
• Source: Imperial College Healthcare NHS Trust
• Contact: Maria Reguenga, BSN
• Phone: 07585095566
• Email: maria.reguenga@nhs.net
• Status: Recruiting
• Phase: N/A
• Start date: March 20, 2024
• Completion date: March 20, 2025