Sedation Management in Pediatric Patients Supported on Mechanical Ventilation

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

Inclusion Criteria:

- Intubated and mechanically ventilated

- Pulmonary disease

Exclusion Criteria:

- Less than or equal to 2 weeks of age or 42 weeks corrected gestational age

- Greater than 18 years of age

- Intubated and mechanically ventilated for immediate post-operative care and
stabilization

- Cyanotic heart disease with unrepaired or palliated right to left intracardiac shunt

- Critical airway (e.g. post laryngotracheal reconstruction)

- Ventilator dependent (including noninvasive) on PICU admission (chronic assisted
ventilation)

- Neuromuscular respiratory failure

- Spinal cord injury above the lumbar region

- Managed by patient controlled analgesia (PCA)or epidural catheter

- Known allergy to any of the study medications (Morphine,Methadone, Midazolam,
Lorazepam)

- Family/Medical team have decided not to provide full support(patient treatment
considered futile)

- Previously enrolled into the current study or enrolled in any other sedation clinical
trial concurrently or within the last 30 days