Sedation Management in Pediatric Patients With Acute Respiratory Failure (The RESTORE Study)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Respiratory Insufficiency Respiratory Distress Syndrome, Newborn Lung Diseases |
Behavioral: Team approach to sedation management Behavioral: Usual approach to sedation management |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Sedation Management in Pediatric Patients With Acute Respiratory Failure |
- Duration of mechanical ventilation [ Time Frame: Measured from the time of endotracheal intubation to the end of scheduled sedation therapy, hospital discharge, or Day 28 (whichever comes first) ] [ Designated as safety issue: No ]
- Time to recovery of acute respiratory failure [ Time Frame: Measured from the time of endotracheal intubation to when participants first meet the criteria to be tested for extubation readiness ] [ Designated as safety issue: No ]
- Duration of weaning from mechanical ventilation [ Time Frame: 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) ] [ Designated as safety issue: No ]
- Occurrence of adverse events [ Time Frame: Measured for the duration of the study ] [ Designated as safety issue: Yes ]
- Detection of life-threatening neurological events [ Time Frame: Measured for the duration of the study ] [ Designated as safety issue: No ]
- Total sedative exposure [ Time Frame: Measured for the duration of the study ] [ Designated as safety issue: No ]
- Occurrence of iatrogenic withdrawal symptoms [ Time Frame: Measured for the duration of the study ] [ Designated as safety issue: No ]
- Pediatric ICU and hospital length of stay [ Time Frame: Measured for the duration of the study ] [ Designated as safety issue: No ]
- Hospital costs [ Time Frame: Measured for the duration of the study ] [ Designated as safety issue: No ]
- Study implementation costs and cost-effectiveness [ Time Frame: Measured for the duration of the study ] [ Designated as safety issue: No ]
- In-hospital mortality [ Time Frame: Measured for the duration of the study ] [ Designated as safety issue: Yes ]
- Post-discharge quality of life and emotional health [ Time Frame: Measured 6 months after pediatric ICU discharge ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 2448 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Participants will receive care at a pediatric ICU that is continuing the usual approach to sedation management.
|
Behavioral: Usual approach to sedation management
The pediatric ICU will continue its usual approach to sedation management.
|
|
Experimental: 2
Participants will receive care at a pediatric ICU that is implementing the team approach to sedation management.
|
Behavioral: Team approach to sedation management
The team approach to sedation management includes the following:
|
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.
Eligibility| Ages Eligible for Study: | up to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Children's Hospital of Alabama | |
| Birmingham, Alabama, United States, 35233 | |
| United States, Arizona | |
| University Medical Center, The University of Arizona | |
| Tucson, Arizona, United States, 85724 | |
| United States, California | |
| Children's Hospital and Research Center at Oakland | |
| Oakland, California, United States, 94609-1809 | |
| Children's Hospital of Orange County | |
| Orange, California, United States, 92868 | |
| Lucile Salter Packard Children's Hospital at Stanford | |
| Palo Alto, California, United States, 94304-0126 | |
| University of California Davis Medical Center | |
| Sacramento, California, United States, 95817 | |
| Children's Hospital at University of California San Francisco Medical Center | |
| San Francisco, California, United States, 94143 | |
| United States, Connecticut | |
| Connecticut Children's Medical Center | |
| Hartford, Connecticut, United States, 06106 | |
| Yale-New Haven Children's Hospital | |
| New Haven, Connecticut, United States, 06520-8064 | |
| United States, Delaware | |
| Nemours/Alfred I. duPont Hospital for Children | |
| Wilmington, Delaware, United States, 19803 | |
| United States, Florida | |
| Holtz Children's Hospital | |
| Miami, Florida, United States, 33136 | |
| Florida Hospital for Children | |
| Orlando, Florida, United States, 32803 | |
| United States, Illinois | |
| Children's Memorial Hospital, Chicago | |
| Chicago, Illinois, United States, 60614-3363 | |
| Advocate Hope Children's Hospital | |
| Oak Lawn, Illinois, United States, 60453 | |
| United States, Maryland | |
| Johns Hopkins Children's Center | |
| Baltimore, Maryland, United States, 21287 | |
| University of Maryland Hospital for Children | |
| Baltimore, Maryland, United States, 21201-1595 | |
| United States, Massachusetts | |
| University of Massachusetts Memorial Children's Medical Center | |
| Worcester, Massachusetts, United States, 01655 | |
| United States, Michigan | |
| C. S. Mott Children's Hospital of the University of Michigan | |
| Ann Arbor, Michigan, United States, 48109-0243 | |
| United States, Missouri | |
| Children's Mercy Hospital, Kansas City | |
| Kansas City, Missouri, United States, 84108 | |
| St. Louis Children's Hospital | |
| St. Louis, Missouri, United States, 63110 | |
| United States, Nebraska | |
| University of Nebraska Medical Center | |
| Omaha, Nebraska, United States, 68114 | |
| United States, New Hampshire | |
| Dartmouth-Hitchcock Medical Center | |
| Lebanon, New Hampshire, United States, 03756-0001 | |
| United States, New York | |
| The Children's Hospital at Montefiore | |
| Bronx, New York, United States, 10467 | |
| Cohen Children's Medical Center of New York | |
| New Hyde Park, New York, United States, 11040 | |
| United States, North Carolina | |
| Duke Children's Hospital and Health Center | |
| Durham, North Carolina, United States, 27710 | |
| United States, Oregon | |
| Doernbecher Children's Hospital | |
| Portland, Oregon, United States, 97239 | |
| United States, Pennsylvania | |
| Children's Hospital of Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Tennessee | |
| Monroe Carell, Jr. Children's Hospital at Vanderbilt | |
| Nashville, Tennessee, United States, 37232-9075 | |
| United States, Texas | |
| Children's Medical Center Dallas | |
| Dallas, Texas, United States, 75235 | |
| Medical City Children's Hospital | |
| Dallas, Texas, United States, 75230 | |
| United States, Utah | |
| Primary Children's Medical Center | |
| Salt Lake City, Utah, United States, 84113 | |
| Principal Investigator: | Martha A.Q. Curley, RN, PhD | University of Pennsylvania |
| Study Director: | David Wypij, PhD | Director, Statistics and Data Coordinating Center; Children's Hospital Boston |
More Information
Additional Information:
No publications provided
| Responsible Party: | University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT00814099 History of Changes |
| Other Study ID Numbers: | 611, U01HL086622, U01 HL086649, U01 HL086622 |
| Study First Received: | December 19, 2008 |
| Last Updated: | June 13, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by University of Pennsylvania:
|
Acute Respiratory Failure Acute Lung Injury |
Additional relevant MeSH terms:
|
Lung Diseases Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Respiratory Insufficiency |
Respiratory Tract Diseases Respiration Disorders Infant, Premature, Diseases Infant, Newborn, Diseases |
ClinicalTrials.gov processed this record on May 23, 2013