Sedation Management in Pediatric Patients Supported on Mechanical Ventilation
Condition: Respiratory Failure
MeSH terms: Respiratory Insufficiency
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this two-year project is to pilot test an intervention to change sedation
      management in pediatric patients supported on mechanical ventilation for acute respiratory
      failure in the pediatric intensive care unit (PICU). While ensuring patient comfort is an
      integral part of pediatric critical care, analgesic and sedative use in this patient
      population is associated with injury; specifically, comfort medications may depress
      spontaneous ventilation and prolong the duration of mechanical ventilation. Additionally,
      drug tolerance develops over time and may precipitate iatrogenic abstinence syndrome
      (chemical withdrawal) when the patient no longer requires sedation. Alternatively, suboptimal
      comfort management contributes to the patient not breathing synchronously with the ventilator
      and/or self-removal of breathing tubes.

      Our group has developed and validated a nurse-implemented sedation algorithm (set of specific
      instructions) to guide titration of comfort medications that may optimize patient comfort and
      reduce the risk of under-medication, but this algorithm needs to be evaluated further. We
      hypothesize that pediatric patients managed per sedation protocol will experience fewer days
      of mechanical ventilation than patients receiving usual care. This research has the potential
      of revolutionizing sedation practices that are driven by and synchronized to patient needs.
    

Detailed description: 
      We propose a two-year project to pilot test and evaluate an intervention to change sedation
      management in pediatric patients supported on mechanical ventilation for acute respiratory
      failure in the PICU. Rather than seeking an elusive ideal drug, this unique nurse-led pilot
      study focuses on optimizing clinical decision making by: (a) multidisciplinary team education
      and consensus building; (b) multidisciplinary team identification of the patient's trajectory
      of illness and daily prescribing of a sedation goal; (c) a nurse-implemented sedation
      algorithm to guide titration of comfort medications; and(d)team feedback on clinical
      performance. This intervention models the most recent sedation clinical practice guideline
      published by the Society of Critical Care Medicine and addresses the only potentially
      manipulable factor influencing extubation failures rates in the Pediatric Intensive Care
      Unit.

      The coordinating center, Children's Hospital Boston, developed, tested and currently uses the
      sedation algorithm as a standard of care. We will pilot the intervention in two separate
      previously selected PICUs that are matched on size and organization, academic affiliation and
      volume of patients supported on mechanical ventilation. One PICU will be randomized to
      receive early intervention while the other will first serve as a control, then will receive a
      delayed intervention.

      The study design is a randomized controlled trial with delayed intervention in the control
      hospital. Because the intervention is an educational and organizational change directed at
      all PICU clinicians, the unit of randomization and analysis is the PICU. During the start-up
      phase, case report forms will be developed and a consensus meeting with all nurse and
      physician co-investigators will be conducted. The purpose of this consensus meeting will be
      to review the Children's Hospital Boston experience with the sedation algorithm and reach
      agreement on its application in the two PICUs. System nuances may impact protocol
      implementation and will require group discussion and multidisciplinary problem solving.

      Study design includes baseline assessment of the organizational structure and comfort
      practices in both units. The PICU randomized to early intervention will then undergo training
      followed by implementation, a one-month respite, and post-data collection to evaluate the
      sustainability of the practice change. The PICU randomized to delayed intervention will start
      with pre-data collection, then undergo training followed by implementation. This design
      allows multiple comparisons; specifically, baseline to intervention/control, pre and post
      comparisons in both units, and sustainability in one unit.

      Training will be multifaceted and will include all clinicians (physicians, nurses, clinical
      pharmacists and physicians-in-training) involved in the sedation management of intubated
      mechanically-ventilated patients. A multidisciplinary, cooperative approach is necessary to
      assure compliance and successful implementation of protocols. Training material will include
      discipline-specific lectures, informal discussions, video on sedation and opioid withdrawal
      scoring, bedside booklets, and physician order sheets. The research team will develop the
      supporting materials. Physician training will focus on sedation and opioid withdrawal
      scoring, identifying the patient's trajectory of illness, collaborating with nursing in
      prescribing the daily sedation goal, and completion of the standardized order template.
      Nursing content will likewise focus on sedation and opioid withdrawal scoring, trajectory
      analysis and collaboration, but also will include practical support on the daily "wake-up"
      test and titration of sedatives. Prior to the intervention phase, all physicians,
      physician-in-training, unit-based clinical pharmacist, charge nurses and full-time nursing
      staff will be required to document their understanding of the intervention by completion of a
      discipline-specific scenario-based self-assessment evaluation. Respiratory therapists will
      also require refresher instruction on extubation readiness testing and general information
      about sedation assessment and sedation algorithm.

      During the implementation phase, daily multidisciplinary rounds will include identification
      of the patient's trajectory of illness and daily prescription of (a) sedation goal and (b)
      sedation parameters. Nurses will titrate the comfort medications as prescribed and perform a
      daily "wake up" test in patients during their stable phase who are not awake. During the
      implementation phase, a member of the research team will round separately on each patient to
      monitor for study compliance and offer staff support and re-training as necessary. This level
      of vigilance is necessary to identify aspects of the algorithm that are challenging to
      clinicians, and accurate reporting of protocol deviations requires an evaluation of the
      context of decision-making. This daily check will not continue in the early intervention arm
      when sustainability is evaluated. During the implementation phase, all sedation orders will
      be derived from standardized physician orders. This order template will serve two purposes:
      physician education and enhanced compliance with the algorithm
    

Intervention name(s): Nurse Implemented Goal-Directed Comfort Algorithm
Intervention type(s): Behavioral
Intervention description(s): See description
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sedation; Mechanical ventilation; Critical illness; Analgesic; Opioid Withdrawal; Benzodiazepine Withdrawal; Nurse