Sedation Management in Pediatric Patients With Acute Respiratory Failure (The RESTORE Study)
Condition: Respiratory Insufficiency; Respiratory Distress Syndrome, Newborn; Lung Diseases
MeSH terms: Lung Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Respiratory Insufficiency
Study type: Interventional
Phase: Phase 3

Summary: 
      People with acute respiratory failure usually require the use of an artificial breathing
      machine, known as a mechanical ventilator. Sedative medications, which help keep people calm
      and reduce anxiety, are often prescribed for children who are on mechanical ventilators.
      However, the longer that sedative medications are used, the longer a child may need to remain
      on mechanical ventilation. This study will evaluate the effectiveness of a team approach to
      sedation management that aims to reduce the number of days that children with acute
      respiratory failure require mechanical ventilation.
    

Detailed description: 
      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.
    

Intervention name(s): Team approach to sedation management; Usual approach to sedation management
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The team approach to sedation management includes the following:
Team education and consensus on the use of sedatives
Team identification of the patient's trajectory of illness and daily prescription of a sedation goal
A nurse-implemented goal-directed comfort algorithm that guides moment-to-moment titration of opioids and benzodiazepines
Team feedback on sedation management performance; The pediatric ICU will continue its usual approach to sedation management.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute Respiratory Failure; Acute Lung Injury