DUGi

Daily sedation interruption added to a protocolized sedative rotation strategy to reduce iatrogenic withdrawal syndrome in the pediatric intensive care unit

http://dugi.udg.edu/item/http:@@@@hdl.handle.net@@10256@@28473

Mechanically ventilated children in the PICU frequently require prolonged exposure to opioids and sedatives. This can lead to oversedation, longer duration of mechanical ventilation, and complications such as IWS and delirium. IWS has an incidence between 35-50% in patients with prolonged sedation. Daily sedation interruption (DSI) may further reduce the sedative burden by limiting bioaccumulation and promoting daily reassessment; however, pediatric evidence remains heterogeneous and IWS has been insufficiently addressed as a primary endpoint. OBJECTIVE: The primary objective of the study is to determinate whether DSI to a protocolized sedative rotation strategy reduces the incidence of IWS in PICU patients aged 2 to 16 years, in mechanically ventilated for more than five days, compared with sedative rotation alone. STUDY DESIGN AND PARTICIPANTS: This is a multicentre, parallel group, randomized controlled trial conducted in level II and III PICU. Prior to study initiation, participating centres will undergo standardized training sessions to harmonize sedation protocols, safety criteria and use of assessment tools. The study is open label, with blinded outcome assessment and statistical analysis. The planned sample size is 336 patients, and randomization will be stratified by age group (2-4,5-9,10-16 years). METHODS: Participants will be randomized 1:1 to control with protocolized sedative drug rotation without DSI, or intervention with the same rotation protocol plus once daily DSI when safety criteria are met. Analgesia will be maintained during DSI. Randomization will be stratified by age group and by centre. IWS will be assessed using SOS-PD, delirium using CAPD, sedation depth using RASS and continuous BIS monitoring and pain using FLACC. Adverse events will include unplanned extubation, accidental removal of lines/tubes, severe agitation during DSI, hypotension requiring intervention, and clinically significant arrhythmias

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