Development of a Sedation Protocol for Mechanically Ventilated Patients: A Mixed-Methods Study

This prospective study will be conducted in three phases following ethical approval and informed consent from patients or their legal guardians. Phase 1 is a quantitative observational study to document current sedation practices in ICU patients, including types and doses of sedatives, frequency and methods of sedation assessment, target sedation levels, and inter-provider variability. Phase 2 includes two components. Phase 2a is a qualitative study using semi-structured interviews and focus group discussions to explore barriers and facilitators to sedation protocol adherence among ICU staff. Phase 2b involves the development of a structured sedation protocol using the modified Delphi method with input from a multidisciplinary expert panel. The protocol will undergo content validation by clinicians, nurses, and psychologists to ensure clarity, relevance, and feasibility. Phase 3 is a single-arm feasibility study to implement the validated sedation protocol in the ICU. The protocol includes RASS-based sedation targets, 4-hourly RASS assessments, twice-daily CAM-ICU delirium checks, standardized sedative titration, daily sedation interruption when appropriate, and a sedation checklist during rounds. ICU staff will receive prior training. Outcomes assessed will include protocol adherence, usability, safety, and staff feedback. Adverse events monitored will include hypotension, bradycardia, respiratory depression, over- or under-sedation, agitation, delirium, and drug-specific complications. Criteria for withdrawal include serious adverse effects or protocol non-compliance. Data collection will include baseline demographic and clinical data, serial RASS assessments every 4 to 6 hours, CAM-ICU assessments twice daily, and follow-up until ICU discharge, including a 7-day post-discharge phone follow-up for delayed adverse effects. The study may be terminated early if significant safety concerns arise. This pilot trial evaluates a non-drug interventional sedation protocol using approved sedatives; hence the trial phase is marked as Not Applicable. This phased approach aims to develop and validate a practical, safe, and effective sedation protocol for ICU patients on mechanical ventilation.