SLeep Evaluation and Effectiveness Protocol for Intensive Care Units (SLEEP-ICU)
A randomised, placebo controlled clinical trial of the efficacy of dexmedetomidine as part of a sleep promotion bundle on sleep quality in adults in intensive care who report a subjective sleep disturbance
South Metropolitan Health Service
100 participants
Feb 4, 2025
Interventional
Conditions
Summary
Incorporating dexmedetomidine into a comprehensive sleep promotion bundle, which includes minimising night-time disruptions and aligning care activities with the patient’s natural sleep-wake cycles, optimising the sleep environment through monitoring temperature, noise and ambient light could significantly enhance sleep quality in ICU patients. Improved sleep may contribute to better recovery outcomes, reduction in delirium incidence, and overall improved patient well-being. The primary objective of this trial is to provide a comprehensive evaluation of the efficacy and safety of dexmedetomidine in improving sleep in adult ICU patients as part of a sleep promotion bundle as determined by the patient’s subjective sleep assessment.
Eligibility
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Interventions
Dexmedetomidine Description: A once only intravenous administration of dexmedetomidine as part of a sleep promotion bundle. Dose: Variable titration per patient based on clinical response, starting at 0.1 and up to 0.7 mcg/kg/hour. Duration of administration: 8 hours from 22:00 to 06:00 the next morning Mode of administration: Continuous intravenous infusion. Sleep Promotion Bundle Description: A 'Sleep Promotion Bundle Checklist' will be provided to the bedside nurse to address to all the items in the sleep promotion bundle which include: Environmental Modifications/Monitoring Setup of sleep environment monitor by bedside to assess environmental conditions including ambient light (measured in lux), temperature (in degrees Celsius) and noise (in decibels) which will be recorded minutely throughout the 8-hour intervention period (2200-0600hrs). Lighting Adjustments (<50lux) adjusting lights in the patient’s room and surroundings to aim for <50 lux according to ambient light instrument during 8-hour intervention period (2200-0600hrs) offering an eye mask for the patient if appropriate Noise Reduction (<50dB) Aim to keep noise below 50db according to decibel reader instrument Minimizing equipment volume and alarms Encouraging staff to speak softly and close doors quietly Offering earplugs for the patient Temperature Control (20-22 C) Ensuring room temperature is at recommended temperature range according to temperature monitoring device (20-22 degrees Celsius) Providing fans or cooling blankets if the patient is too warm Offering warming blankets to maintain the appropriate temperature Comfort and Positioning The goal is to ensure patient comfort. Nurses will adjust pillows and bedding to achieve the most comfortable position for the patient as subjectively reported by patient. There is no specific guideline for proper positioning, and this may vary based on individual needs and clinical judgment or requirement. Cluster Care Activities Clustering necessary care activities to minimise disturbances Scheduling medications, vital sign checks, and other care tasks to allow uninterrupted sleep periods Pain Management Assessing and managing the patient’s pain effectively Strategies used to manage adherence to the interventions: Monitoring electronic medical records, nursing checklist, staff training and direct supervision from senior nursing.
Locations(3)
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ACTRN12624000991516