Sedation Management in Pediatric Patients With Acute Respiratory Failure (The RESTORE Study)
- Conditions
- Respiratory Distress Syndrome, NewbornLung DiseasesRespiratory Insufficiency
- Registration Number
- NCT00814099
- Lead Sponsor
- University of Pennsylvania
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2449
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Duration of mechanical ventilation Measured from the time of endotracheal intubation to the end of scheduled sedation therapy, hospital discharge, or Day 28 (whichever comes first)
- Secondary Outcome Measures
Name Time Method Time to recovery of acute respiratory failure Measured from the time of endotracheal intubation to when participants first meet the criteria to be tested for extubation readiness Duration of weaning from mechanical ventilation Measured from the time participants meet the criteria to be tested for extubation readiness until the time of the first successful extubation (defined as extubation for more than 24 hours) Occurrence of adverse events Measured for the duration of the study Detection of life-threatening neurological events Measured for the duration of the study Total sedative exposure Measured for the duration of the study Occurrence of iatrogenic withdrawal symptoms Measured for the duration of the study Pediatric ICU and hospital length of stay Measured for the duration of the study Hospital costs Measured for the duration of the study Study implementation costs and cost-effectiveness Measured for the duration of the study In-hospital mortality Measured for the duration of the study Post-discharge quality of life and emotional health Measured 6 months after pediatric ICU discharge
Trial Locations
- Locations (31)
Children's Hospital of Alabama
🇺🇸Birmingham, Alabama, United States
University Medical Center, The University of Arizona
🇺🇸Tucson, Arizona, United States
Children's Hospital and Research Center at Oakland
🇺🇸Oakland, California, United States
Children's Hospital of Orange County
🇺🇸Orange, California, United States
Lucile Salter Packard Children's Hospital at Stanford
🇺🇸Palo Alto, California, United States
University of California Davis Medical Center
🇺🇸Sacramento, California, United States
Children's Hospital at University of California San Francisco Medical Center
🇺🇸San Francisco, California, United States
Connecticut Children's Medical Center
🇺🇸Hartford, Connecticut, United States
Yale-New Haven Children's Hospital
🇺🇸New Haven, Connecticut, United States
Nemours/Alfred I. duPont Hospital for Children
🇺🇸Wilmington, Delaware, United States
Scroll for more (21 remaining)Children's Hospital of Alabama🇺🇸Birmingham, Alabama, United States