Health TrialsbyHealthPanel

Analgesia-First Sedation in Trauma Patients

ConditionsMechanical VentilationRespiratory Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorialCare Health System

About this trial

The study's aim is to ascertain the best approach for providing sedation and pain management for patients who have sustained trauma and are requiring respiratory support from a mechanical ventilator. The common approach to patients who need mechanical ventilation is to provide continuous drips of sedatives and pain medicine and awaken the patient once a day to check the brain functions. Another approach is to provide pain medicine and reserve sedatives for only a short duration when needed. The difference between approaches has not been studied in Trauma patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥ 18 years of age

Mechanically ventilated with an expected duration of MV ≥ 48h

Initiated continuous sedative/analgesic infusions by the ICU team

Patient is a candidate for MV weaning

Disqualifiers

Admission after resuscitation from cardiac arrest

Significant neurological deficit due to a chronic disorder

History of alcohol dependence and/or other illicit drug abuse

Prior administration of continuous sedative/analgesic from a transferring institution

Trial design

Design model

Parallel

Treatments tested in this trial

  • Analgesia First Sedation Strategy for Mechanically Ventilated (MV) Trauma Subjects

    Other intervention

    The Intervention is using a sedation strategy for MV trauma that initially targets pain by intermittent boluses followed by an IV drip only if required. Sedatives are limited to agitation management and for a limited duration as needed. This "analgo-sedation" approach differs from the approach of using IV drips of analgesics and sedatives simultaneously and discontinuing both once daily to assess subjects.

  • Protocol Directed Sedation and Daily Sedation Interruption

    Other intervention

    The active comparator in this study is using a sedation strategy for MV trauma that uses IV drips of analgesics and sedatives simultaneously and discontinues both once daily to assess subjects.

Treatment groups

170 Participants
are divided into 2 treatment groups
Group A: Analgesia First SedationExperimental treatment 1 intervention
Group B: Protocol Directed Sedation and Daily Sedation InterruptionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Mechanical Ventilation days until successful extubation

Duration of mechanical ventilation

Time frame
28 days

Secondary outcomes

1

Duration of MV weaning

Time from initiation of MV weaning to successful extubation

Time frame
28 days

Other outcomes

1

ICU length of stay

Duration of ICU stay (days)

Time frame
28 days
2

Adverse Events related to Mechanical Ventilation

The occurrence of any adverse event that is related to MV (e.g., unplanned extubation, delirium)

Time frame
28 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

MemorialCare Health System

Lead sponsor

Source ClinicalTrials.gov
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