The RESTORE Clinical Trial
RESTORE Study Overview
RESTORE stands for the "Randomized Evaluation of Sedation Titration for Respiratory failure." The RESTORE study was funded by the National Institute of Health (NIH) and was conducted at 31 pediatric Intensive Care Units (PICUs) across the United States. The study was done to learn more about the best ways to keep infants and children comfortable and safe when they needed mechanical ventilation (breathing machines) in the ICU. RESTORE studies whether the comfort medication used in children with acute respiratory failure affected how long they needed to be supported on the breathing machine and their physical and emotional health 6 months after hospital discharge.
Making sure very sick infants and children on mechanical ventilation are safe and comfortable is very important. Although there are benefits in using sedation in young children who are unable to understand the importance of life-saving tubes in the ICU, sedative use is associated with other problems, these medications may depress a child's breathing and prolong the child's time on the breathing machine. Over time, children may need more sedation, which will require weaning to avoid negative effects. These issues add to the personal and financial burden of intensive care.
RESTORE tested a different approach to sedation management that included:
(a) Professional education and agreement on which sedatives to use in the pediatric ICU.
(b) Setting an individual sedation goal for each patient every day.
(c) Having the nurses manage the sedation using a specific plan.
(d) Providing feedback to the bedside team on how well the managed a child's sedation.
31 pediatric ICUs participated in RESTORE. Half of the ICUs managed child's sedation using RESTORE and half of the ICUs used their typical way of managing sedation. In total, about 2,500 infants and children on breathing machines participated in the research study. We believed that RESTORE would help shorten a child's time on the breathing machine, that the child would receive less sedatives with better level of comfort, have fewer negative effects from the sedatives and have better post-discharge health.
This study was important because the results will improve how we manage sedation in sick infants and children who require breathing support for acute respiratory failure and will provide important financial and follow-up information that will enhance patient care. What we learn will help establish a new standard of care that will influence future studies evaluating new or different combinations of sedative agents.