International journal of clinical trials · 2026
Effectiveness of analgosedation protocol on duration of mechanical ventilation in adults with trauma: a pragmatic, cluster and randomized study.
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Tanios Maged A, Nguyen Huan Mark, Nahmias Jeffry, Park Hyunsoon, Patel Jay, Beltran Antonio, Tanios Michael, Mahidhara Meera, Shaban Youssef, Fraser Douglas R, Devlin John W
Аннотация
BACKGROUND: Sedation practices in trauma intensive care unit (ICU) patients requiring invasive mechanical ventilation (IMV) are still not well studied. While protocol-directed sedation (PDS) and spontaneous awakening trials (SAT) have improved outcomes in non-trauma groups, their use in trauma patients-who often experience higher pain levels, substance use, and complex injuries-is uncertain. Analgosedation, which gives priority to analgesics before sedatives, may have benefits in this group but has not been thoroughly tested in trauma ICUs.
METHODS: This is a 24-month, single-center, pragmatic, cluster-randomized controlled trial with a crossover design comparing an analgosedation (+SAT) protocol to a traditional PDS+SAT protocol. Adult trauma ICU patients receiving IMV and expected to need continuous sedation for at least 48 hours are enrolled. The primary outcome is ventilator-free days at day 10 (VFD-10). Secondary outcomes include time to weaning, sedative and opioid exposure, delirium-and coma-free days, self-extubation, ICU/hospital length of stay, and mortality. Interventions are implemented throughout the ICU each month, with crossover randomization. A waiver of informed consent was granted due to the patient's incapacity and the minimal risk involved. Data will be analyzed using intention-to-treat principles and time-dependent Cox models to account for clinical confounders.
CONCLUSIONS: This trial aims to determine whether an analgosedation strategy improves clinically meaningful outcomes in mechanically ventilated trauma ICU patients compared to a traditional sedation approach. The findings will address a critical evidence gap and inform sedation protocols tailored to trauma populations, potentially enhancing recovery and decreasing ICU workload.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05751863 Protocol version: 4.0.
METHODS: This is a 24-month, single-center, pragmatic, cluster-randomized controlled trial with a crossover design comparing an analgosedation (+SAT) protocol to a traditional PDS+SAT protocol. Adult trauma ICU patients receiving IMV and expected to need continuous sedation for at least 48 hours are enrolled. The primary outcome is ventilator-free days at day 10 (VFD-10). Secondary outcomes include time to weaning, sedative and opioid exposure, delirium-and coma-free days, self-extubation, ICU/hospital length of stay, and mortality. Interventions are implemented throughout the ICU each month, with crossover randomization. A waiver of informed consent was granted due to the patient's incapacity and the minimal risk involved. Data will be analyzed using intention-to-treat principles and time-dependent Cox models to account for clinical confounders.
CONCLUSIONS: This trial aims to determine whether an analgosedation strategy improves clinically meaningful outcomes in mechanically ventilated trauma ICU patients compared to a traditional sedation approach. The findings will address a critical evidence gap and inform sedation protocols tailored to trauma populations, potentially enhancing recovery and decreasing ICU workload.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05751863 Protocol version: 4.0.