The QUIET Study Quality Sleep Using ear plugs in the Intensive CarE UniT: A Pilot Randomised Controlled Trial

Participants randomised to postoperative placement of earplugs in ICU Trial participants randomised to receive ear plugs will have ear plugs placed within 30 minutes of arrival in the ICU from the operating theater. Ear plugs will remain in situ until a clinical decision has been made to either reduce or cease sedative agents with the objective of allowing the patient to regain consciousness, to assess neurological status, or otherwise at the request of the treating clinician or bedside nurse. Ear plugs will be reinserted if a clinical decision is made for the dose of the sedative agents to be increased or to achieve a deeper level of sedation or at the end of neurological assessment. It is normal practice for the treating clinician to order reduction or cessation in the administration of sedation in conjunction with the gradual reduction in mechanical ventilatory assistance via an endotracheal tube (weaning of sedation and weaning of ventilation). At the commencement of this period of weaning of sedation or ventilation or both, earplugs will be removed. Following the removal of the patient’s endotracheal tube, earplugs will be reinserted while the patient is admitted to the ICU between the hours of 2200-0600, and at any other time of planned sleep or as requested by the participant. Ear plugs will be removed at any time as requested by the patient or if the patient becomes agitated. All other treatment will be according to standard perioperative care at the direction of the treating team. The duration of the intervention period is the duration of the ICU stay. The earplugs to be used are memory foam earplugs to be replaced daily. Adherence will be monitored using a log of earplug use time.