Objective: To assess the feasibility of a definitive, randomised controlled trial of earplugs as a noise-abatement strategy to improve sleep and reduce delirium in patients admitted to the intensive care unit.
Design and setting: An open-label trial of 40 patients randomised in a 1:1 ratio to receive earplugs in addition to standard care, or standard care alone, conducted in a 10-bed ICU of a large, private hospital in Perth, Western Australia.
Participants and intervention: Patients were eligible for participation if they were expected to be undergoing mechanical ventilation (MV) on admission to the ICU. Patients assigned to receive earplugs had earplugs placed on admission to the ICU and were offered earplug placement between 10 pm and 6 am for the first night in the ICU once they were extubated. Earplugs were not provided for patients assigned to standard care.
Main outcome measure: The primary outcome of study feasibility was assessed using criteria for acceptability of the intervention and protocol compliance.
Results: Of the 20 participants randomised to receive earplugs, 19 had earplugs placed within 6 hours of ICU admission, corresponding to 76% of the MV time (mean time with earplugs, 7.5 hours [SD, 5.3 hours]). Earplugs were placed for 18 of 20 participants during their first full night after extubation, corresponding to 78% of the total overnight time (mean time with earplugs, 6.2 hours [SD, 2.5 hours]).
Conclusion: A definitive study of earplugs as a noiseabatement strategy for patients admitted to the ICU is feasible on the basis of participant acceptability of the intervention and protocol compliance.
Trial registration: Australian New Zealand Clinical Trials Registry ACTRN12615001125516.