Daily sedation interruption in mechanically ventilated critically ill patients cared for with a sedation protocol: a randomized controlled trial.
Sangeeta Mehta, Lisa Burry, Deborah Cook...
https://pubmed.ncbi.nlm.nih.gov/23180503Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID05751863
Analgesia-First Sedation in Trauma Patients Comparing Intermittent Pain Medication Doses to Continuous Sedative Infusions with Daily Interruption
Led by MemorialCare Health System · Updated on 2025-07-09
170
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the best sedation and pain management approach for trauma patients needing mechanical ventilation. The study compares continuous sedative and pain medication infusions with an analgesia-first strategy, where sedatives are reserved for brief use as needed. Although sedation protocols have improved outcomes in medical ICU patients, it remains unclear which method is better for surgical trauma patients. Participants will be randomly assigned to receive either analgesia-first sedation using intermittent fentanyl doses with sedatives added only if necessary, or protocol-directed sedation with continuous infusions of analgesics and sedatives interrupted daily. Both groups will be managed with approved ICU protocols, with daily assessments for ventilator weaning. During the study, participants will be monitored for days on mechanical ventilation until successful extubation, as well as duration of weaning. Researchers will track ICU and hospital length of stay, sedation levels, pain control, and safety outcomes. The total participation time includes at least 28 days of outcome measurement, with regular assessments to guide sedation and ventilation management.
CONDITIONS
Brief Title
Analgesia-First Sedation in Trauma Patients
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Mechanically ventilated with expected duration of mechanical ventilation of at least 48 hours
- Started continuous sedative or analgesic infusions in the ICU
- Candidate for mechanical ventilation weaning
You will not qualify if you...
- Admission after resuscitation from cardiac arrest
- Significant neurological deficit from a chronic disorder
- History of alcohol dependence or illicit drug abuse
- Prior continuous sedative or analgesic administration from another institution
- Receiving neuromuscular blocking agents
- Allergy to midazolam, lorazepam, or propofol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 28 days
Participants receive one of two sedation strategies to facilitate mechanical ventilation: either intermittent analgesic boluses followed by sedative infusions as needed (Analgesia First Sedation), or continuous intravenous infusions of analgesics and sedatives with daily interruption (Protocol Directed Sedation and Daily Sedation Interruption). Participants are assessed daily for ventilator weaning readiness.
Daily assessments during mechanical ventilation
Follow-up
Duration - Up to 28 days
After cessation of sedation treatment, participants are monitored for mechanical ventilation outcomes and ICU/hospital length of stay.
Visits as needed during ICU stay
Trial Site Locations
Total: 1 location
1
Long Beach Memorial Medical Center
Long Beach, California, United States, 90806
Actively Recruiting
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Research Team
M
Maged Tanios, MD, MPH
H
Hyunsoon Park, RN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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Published Research Related To This Trial
Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU.
John W Devlin, Yoanna Skrobik, Céline Gélinas...
https://pubmed.ncbi.nlm.nih.gov/30113379A protocol of no sedation for critically ill patients receiving mechanical ventilation: a randomised trial.
Thomas Strøm, Torben Martinussen, Palle Toft
https://pubmed.ncbi.nlm.nih.gov/20116842Daily interruption of sedative infusions in critically ill patients undergoing mechanical ventilation.
J P Kress, A S Pohlman, M F O'Connor...
https://pubmed.ncbi.nlm.nih.gov/10816184Effectiveness 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...
https://pubmed.ncbi.nlm.nih.gov/41717531