Reducing Delirium After CABG Surgery With Early Activation and Sleep-Promoting Routines

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-99
SponsorNational University Hospital, Singapore

About this trial

The goal of this randomized-controlled trial (RCT) is to compare the effectiveness of the DREAMS-OT intervention with standard care in reducing post-Coronary Artery Bypass Graft (CABG) surgery delirium in patients undergoing CABG surgery.

The aims of the study are:

1. To determine if early and intensive OT will lower the incidence of post-op delirium in CABG patients compared to standard are. 2. To determine the cost effectiveness of the DREAMS-OT intervention.

The study team will compare intervention group and standard care group (control group) to see if there is a reduction in the incidence of delirium in patients 5 days post-CABG.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients deemed medically suitable for elective CABG surgery

Patients aged 21 years and above

Patients who are English or Mandarin speaking.

Patients who are able to provide consent

Disqualifiers

Patients who speak other languages are excluded due to the language requirements of certain outcome measures.

Patients with premorbid severe hearing impairment, severe cognitive impairment, progressive neurological disorders and psychological disorders will be excluded.

Patients with surgical complications resulting in profuse bleeding from any invasive sites, septic shock unresponsive to maximal treatment, and those who are moribund or have an expected mortality within 48 hours will be excluded.

Pregnant women will also be excluded from the study as well.

Trial design

Design model

Parallel

Treatments tested in this trial

  • DREAMS-OT

    Other intervention

    Patients will receive the DREAMS-OT protocol 3 times per day, 20 minutes per therapy session. Intervention frequency will be confirmed with a feasibility trial. If not feasible to maintain 3 times per day, the intervention will still be maintained at the same intensity of 1 hour per day, with a graded approach.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: DREAMS-OT Arm (Intervention Group)Experimental treatment 1 intervention
Group B: Standard Care Arm (Control Group)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

Delirium

Incidence of delirium from Day 1 to Day 5 post-CABG are measured using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) assessment tool.

Time frame
Day 1 of post-CABG (AM and PM), Day 2 of post-CABG (AM and PM), Day 3 of post-CABG (AM and PM), Day 4 of post-CABG (AM and PM), Day 5 of post-CABG (AM and PM); (+/- 1 day for last measurement)
2

Delirium

Incidence of delirium from Day 1 to Day 5 post-CABG are measured using the 3-Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM).

Time frame
Day 1 of post-CABG (AM and PM), Day 2 of post-CABG (AM and PM), Day 3 of post-CABG (AM and PM), Day 4 of post-CABG (AM and PM), Day 5 of post-CABG (AM and PM); (+/- 1 day for last measurement)

Secondary outcomes

1

Length of Stay

Length of stay in ICU and hospital in days

Time frame
3-months post-CABG (+/- 1 month)
2

Duration of Delirium

Duration of delirium in subgroup of participants who develop delirium

Time frame
Day 1 of post-CABG (AM and PM), Day 2 of post-CABG (AM and PM), Day 3 of post-CABG (AM and PM), Day 4 of post-CABG (AM and PM), Day 5 of post-CABG (AM and PM)
3

Sleep Quality

Sleep quality (Duration of Total Sleep, Light Sleep, Deep Sleep and Rapid Eye Movement (REM) Sleep in hours) as measured with Oura Ring, a wearable sleep tracking device

Time frame
2 weeks prior to operation (Baseline measurement, +/- 2 weeks), Day 1 of post-CABG, Day 2 of post-CABG (+/- 1 day), 3 months post-CABG for 3 consecutive days (+/- 1 month)
4

Functional Status

Functional status measured using Acute Care Index of Function (ACIF). The score ranges from 0 - 176 (or 206 for wheelchair-bound participants), with higher scores indicating better functional performance.

Time frame
Day 5 of post-CABG (+/- 1 day)

Other outcomes

1

Richmond Agitation Sedation Scale (RASS)

RASS which will be used for CAM-ICU assessment (primary outcome measure). The scores range from -5 to +4, with higher score indicating greater agitation and lower scores indicating deeper sedation.

Time frame
Day 1 of post-CABG (AM and PM), Day 2 of post-CABG (AM and PM), Day 3 of post-CABG (AM and PM), Day 4 of post-CABG (AM and PM), Day 5 of post-CABG (AM and PM)
2

European System for Cardiac Operative Risk Evaluation (EuroSCORE) 2

EuroSCORE 2 is used to assess the risk of heart surgery of participants before their CABG surgery. The score ranges from 0% - 100%, with higher percentage indicating worse outcome or greater predicted mortality risk.

Time frame
2 weeks prior to operation (Baseline measurement, +/- 2 weeks)
3

Charlson Comorbidity Index (CCI)

Predicts mortality for participant before CABG surgery. The score ranges from 0 - 37, with higher score indicating worse outcome or greater comorbidity burden and mortality risk.

Time frame
2 weeks prior to operation (Baseline measurement, +/- 2 weeks)
4

Clinical Frailty Index (CFI)

Measure health status of participant before surgery. The score range from 0 - 9, with higher score indicating worse outcome.

Time frame
2 weeks prior to operation (Baseline measurement, +/- 2 weeks)

Sponsors and contacts

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National University Hospital, Singapore

Lead sponsor

National University of Singapore

Collaborator

National Medical Research Council (NMRC), Singapore

Collaborator