Effectiveness of analgosedation protocol on duration of mechanical ventilation in adults with trauma: a pragmatic, cluster and randomized study

Maged A. Tanios; Huan Mark  Nguyen; Jeffry Nahmias; Hyunsoon Park; Jay Patel; Antonio Beltran; Michael Tanios; Meera Mahidhara; Youssef Shaban; Douglas Fraser; John Devlin

doi:10.18203/2349-3259.ijct20260047

Authors

Maged A. Tanios Memorial Care, Long Beach Medical Center, Department of Medicine, Long Beach, CA; University of California, Irvine, Division of Pulmonary and Critical Care Medicine, Irvine, CA
Huan Mark Nguyen Western University of Health Sciences, College of Pharmacy, Pomona, CA
Jeffry Nahmias University of California, Irvine, UCI Medical Center, Department of Surgery, Irvine, CA
Hyunsoon Park Memorial Care, Long Beach Medical Center, Long Beach, CA
Jay Patel Memorial Care, Long Beach Medical Center, Department of Medicine, Long Beach, CA; University of California, Irvine, Division of Pulmonary and Critical Care Medicine, Irvine, CA
Antonio Beltran Memorial Care, Long Beach Medical Center, Department of Medicine, Long Beach, CA; University of California, Irvine, Division of Pulmonary and Critical Care Medicine, Irvine, CA
Michael Tanios University of California, Berkeley, Berkeley, CA
Meera Mahidhara University of California, Berkeley, Berkeley, CA
Youssef Shaban MemorialCare, Long Beach Medical Center, Department of Surgery, Long Beach, CA
Douglas Fraser MemorialCare, Long Beach Medical Center, Department of Surgery, Long Beach, CA
John Devlin Brigham and Women’s Hospital, Division of Pulmonary and Critical Care Medicine, Boston, MA; Northeastern University, Bouve College of Health Sciences, Boston, MA

DOI:

https://doi.org/10.18203/2349-3259.ijct20260047

Keywords:

Sedation, Analgosedation, Mechanical ventilation, Trauma, Respiratory failure

Abstract

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.

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