Pilot Study on Pairing Sedation Strategies and Weaning
- Conditions
- Acute Respiratory Failure
- Interventions
- Drug: Sedation Protocol with Daily InterruptionDrug: Sedation Protocol Without Daily Interruption
- Registration Number
- NCT02219659
- Lead Sponsor
- MemorialCare Health System
- Brief Summary
A three-arm, randomized, pilot feasibility, study to assess the effect three validated sedation strategies on outcomes of patient on mechanical ventilation.
- Detailed Description
A three-arm, randomized, pilot feasibility, study to assess the effect three validated sedation strategies on outcomes of patient on mechanical ventilation.
A significant proportion of patients admitted to the intensive care unit (ICU) require mechanical ventilation (MV). To maintain comfort and facilitate quality care, large quantities of sedatives and analgesics are often administered either by continuous infusion, with or without daily interruption (DI) of sedation, or as intermittent doses of analgesics. Three validated sedation strategies are currently available. A recently published study ( trial has shown that instituting protocol-directed sedation in patients requiring continuous infusion of sedatives and analgesics, whether or not daily interruption (DI) of the sedative occurs, will improve MV outcomes, specifically the duration of MV. Girard et al performed a randomized, multicenter, clinical trial (ABC- Awakening and Breathing Controlled trial) evaluating the pairing of a spontaneous awakening trial (SAT) with an SBT. Most recently, a Danish study by Strom et al. investigated whether an analgesia-first approach to patient comfort that consisted of intermittent doses of intravenous opioids, and the initiation of IV sedation for short periods only when acute agitation was present, would be superior to a protocol similar to the ABC trial. While the three above mentioned approaches are accepted and currently implemented in the critical care community there is no comparative study or evaluation on the optimal timing to conduct a spontaneous breathing trial (SBT) for assessing weaning readiness with each of these strategies. It is possible that a SAT strategy, where sedative and opioid infusions are interrupted, may lead to more agitation and anxiety than a strategy in patients managed with a sedation protocol where intravenous sedative and analgesic therapy is regularly titrated to maintain patients in a lightly sedated state. Moreover, it remains unclear whether there are advantages of an analgesia-first sedation strategy over either an SAT or sedation protocol strategy in terms of the time it takes to wean patients from MV. However, it is noteworthy to mention that the analgesia-first strategy was associated with more delirium episodes, which were attributed to the ability to assess for it in a more awake patient. However, comparing delirium occurrence in studies with different sedation goals and methodologies may be inaccurate.
The investigators therefore propose a three-arm, randomized, pilot feasibility, study to assess the effect of these three (3) validated strategies for sedation and pain management
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
- ≥ 18 years of age
- Mechanically ventilated with an expected duration of MV ≥ 48 hours
- ICU team has initiated continuous sedative and/or /analgesic infusions
Exclusion criteria:
- Admission after resuscitation from cardiac arrest
- Admission with traumatic brain injury or another acute neurologic event (e,g. stroke, uncontrolled seizures).
- History of severe dementia
- Admission because of acute alcohol withdrawal or acute drug intoxication
- Administration of more than 24 hours of continuous sedation
- Allergy to fentanyl, midazolam, and/or propofol
- Lack of informed consent
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fentanyl push first Fentanyl Push First This arm attempts to manage patient's pain and agitation with analgesia first. Fentanyl intravenous (IV) pushes are administered every 5 minutes as needed to target pain and sedation score, up to 4 doses per hour. Every morning 120-min CPAP trial is performed as long as patient's RASS score is 0 to -2 and patient passes the SBT safety screen. If fentanyl IV push doses alone cannot manage patient's pain and agitation (could not reach the target score), notify the study team. Fentanyl infusion is started and titrated to target pain and sedation score up to 6 hours. If fentanyl infusion is titrated up twice consecutively and target pain and sedation score are not met, notify the study team. Propofol infusion is started and titrated to target RASS score up to 6 hours. Sedation protocol with interruption Sedation Protocol with Daily Interruption Continuous infusion of fentanyl and midazolam is started per protocol. Both drugs are titrated to target pain score (0 to 3) using Critical Care Pain Observation Tool (CPOT) and target sedation score (0 to -3) using Richmond Agitation Sedation Scale (RASS). Every morning both drugs are stopped (Daily Interruption) and patient's wakefulness is assessed per protocol. If patient's pain and RASS score stays within the target, both drugs are kept off. If patient shows any signs and symptoms of pain or agitation (described in the study protocol), both drugs are restarted at a half dose of the previous dose and titrated to target pain and RASS score. Every morning both drugs are stopped and when patient is awake and met the SBT safety screen, 120-min continuous positive airway pressure (CPAP) trial is performed. Sedation protocol without Interruption Sedation Protocol Without Daily Interruption Continuous infusion of fentanyl and midazolam is started per protocol. Both drugs are titrated to target pain score (0 to 3) using Critical Care Pain Observation Tool (CPOT) and target sedation score (0 to -3) using Richmond Agitation Sedation Scale (RASS). Daily interruption of fentanyl and midazolam is not performed. Every morning 120-min CPAP trial is performed as long as the patient's RASS score is 0 to -2 and the patient passes the SBT safety screen.
- Primary Outcome Measures
Name Time Method Study Feasibility Up to 28 days Protocol/study feasibility based on protocol compliance.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Long Beach Memorial Medical Center
🇺🇸Long Beach, California, United States