Sedation Management in Pediatric Patients With Acute Respiratory Failure (The RESTORE Study)

People who are hospitalized for acute respiratory failure are typically supported on
mechanical ventilation, which delivers oxygen and a continuous level of pressure to the
damaged lungs. Over 90% of infants and children supported on mechanical ventilation receive
some form of sedation medication, which helps keep them safe, calm, and comfortable.
Unfortunately, the use of sedation medications may prolong the duration of mechanical
ventilation, which can lead to an increased risk for pneumonia and other complications.

Recent studies among adults in intensive care units (ICUs) have shown that when doctors and
nurses work together as a team to manage the use of sedation medication, patients are taken
off mechanical ventilation sooner and with fewer side effects. This team strategy includes
the following:

- Training and discussion between doctors and nurses regarding which sedative medications
should be used

- Having doctors and nurses jointly identify the patient's progress and a daily sedation
medication goal for the patient

- Having nurses use a decision-making tool to help guide changes in a patient's sedative
medication dose

- Keeping track of patient care, which allows doctors and nurses to evaluate the
effectiveness of how they manage each patient's sedative medication use

This study will examine the use of the sedation management strategy for infants and children
in pediatric ICUs who have acute respiratory failure and require mechanical ventilation. The
purpose of the study is to evaluate whether this team approach to sedation medication
management is more effective than the usual approach at reducing the amount of time children
remain on mechanical ventilators. Study researchers will also examine the cost-effectiveness
of this approach and associated quality of life factors.

All participants will be enrolled within 24 hours of starting mechanical ventilation and
will be monitored until they receive their last dose of sedative medication, hospital
discharge, or Day 28 (whichever comes first). During a 3-month baseline period, all
participating pediatric ICUs will provide their usual sedation management, and study
researchers will review participants' medical records on a daily basis. Each pediatric ICU
will then be randomly assigned to either the control group or the team approach group.
Pediatric ICUs in the control group will continue to provide usual care for sedation
management. Pediatric ICUs in the team approach group will implement the team approach
sedation management guidelines. For both groups, pain and sedation levels will be monitored
daily, and study researchers will review participants' medical records on a daily basis,
too. Six months after hospital discharge, half of the participants and their parents will
complete a follow-up survey and take part in a telephone interview to assess quality of
life, psychological factors, and health-related resource use.

Inclusion Criteria:

- At least 2 weeks of age (and at least 42 weeks post-menstrual age) and less than 18
years of age

- Intubated and mechanically ventilated for acute lung disease

Exclusion Criteria:

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

- History of single ventricle at any stage of repair

- Congenital diaphragmatic hernia or paralysis

- Primary pulmonary hypertension

- Critical airway or anatomical obstruction of the lower airway

- Ventilator dependent upon pediatric ICU admission

- Neuromuscular respiratory failure

- Spinal cord injury above the lumbar region

- Pain managed by patient-controlled analgesia or epidural catheter

- Patient transferred from an outside ICU where sedatives had already been administered
for more than 24 hours

- Family or medical team has decided not to provide full support

- Enrolled in any other critical care interventional clinical trial concurrently or in
the 30 days before study entry

- Known allergy to any of the study medications

- Pregnancy