Sedation Management in Pediatric Patients With Acute Respiratory Failure (The RESTORE Study)
NCT ID: NCT00814099
Last Updated: 2015-07-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
2449 participants
INTERVENTIONAL
2009-01-31
2013-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Participants will receive care at a pediatric ICU that is continuing the usual approach to sedation management.
Usual approach to sedation management
The pediatric ICU will continue its usual approach to sedation management.
2
Participants will receive care at a pediatric ICU that is implementing the team approach to sedation management.
Team approach to sedation management
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
Interventions
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Team approach to sedation management
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
Usual approach to sedation management
The pediatric ICU will continue its usual approach to sedation management.
Eligibility Criteria
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Inclusion Criteria
* Intubated and mechanically ventilated for acute lung disease
Exclusion Criteria
* 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
2 Weeks
18 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
University of Pennsylvania
OTHER
Responsible Party
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Principal Investigators
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Martha A.Q. Curley, RN, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
David Wypij, PhD
Role: STUDY_DIRECTOR
Director, Statistics and Data Coordinating Center; Children's Hospital Boston
Locations
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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
Holtz Children's Hospital
Miami, Florida, United States
Florida Hospital for Children
Orlando, Florida, United States
Children's Memorial Hospital, Chicago
Chicago, Illinois, United States
Advocate Hope Children's Hospital
Oak Lawn, Illinois, United States
University of Maryland Hospital for Children
Baltimore, Maryland, United States
Johns Hopkins Children's Center
Baltimore, Maryland, United States
University of Massachusetts Memorial Children's Medical Center
Worcester, Massachusetts, United States
C. S. Mott Children's Hospital of the University of Michigan
Ann Arbor, Michigan, United States
Children's Mercy Hospital, Kansas City
Kansas City, Missouri, United States
St. Louis Children's Hospital
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Cohen Children's Medical Center of New York
New Hyde Park, New York, United States
The Children's Hospital at Montefiore
The Bronx, New York, United States
Duke Children's Hospital and Health Center
Durham, North Carolina, United States
Doernbecher Children's Hospital
Portland, Oregon, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Monroe Carell, Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, United States
Medical City Children's Hospital
Dallas, Texas, United States
Children's Medical Center Dallas
Dallas, Texas, United States
Primary Children's Medical Center
Salt Lake City, Utah, United States
Countries
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References
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Tasker RC. Respiratory Support for Bronchiolitis Management in the PICU: What We Now Know and What We Want to Know. Pediatr Crit Care Med. 2025 Jun 1;26(6):e827-e831. doi: 10.1097/PCC.0000000000003765. Epub 2025 Jun 5. No abstract available.
Fischer M, Ngendahimana DK, Watson RS, Schwarz AJ, Shein SL. Cognitive, Functional, and Quality of Life Outcomes 6 Months After Mechanical Ventilation for Bronchiolitis: A Secondary Analysis of Data From the Randomized Evaluation of Sedation Titration for Respiratory Failure Trial ( RESTORE ). Pediatr Crit Care Med. 2024 Mar 1;25(3):e129-e139. doi: 10.1097/PCC.0000000000003405. Epub 2023 Dec 1.
Olszewski AE, Dervan LA, Smith MB, Asaro LA, Wypij D, Curley MAQ, Watson RS. Risk Factors for Positive Post-Traumatic Stress Disorder Screening and Associated Outcomes in Children Surviving Acute Respiratory Failure: A Secondary Analysis of the Randomized Evaluation of Sedation Titration for Respiratory Failure Clinical Trial. Pediatr Crit Care Med. 2023 Mar 1;24(3):222-232. doi: 10.1097/PCC.0000000000003150. Epub 2022 Dec 23.
Monteiro ACC, Flori H, Dahmer MK, Sim MS, Quasney MW, Curley MAQ, Matthay MA, Sapru A; BALI Study Investigators of the Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network. Thrombomodulin is associated with increased mortality and organ failure in mechanically ventilated children with acute respiratory failure: biomarker analysis from a multicenter randomized controlled trial. Crit Care. 2021 Aug 3;25(1):271. doi: 10.1186/s13054-021-03626-1.
Kopp W, Gedeit RG, Asaro LA, McLaughlin GE, Wypij D, Curley MAQ; Randomized Evaluation of Sedation Titration for Respiratory Failure (RESTORE) Study Investigators. The Impact of Preintubation Noninvasive Ventilation on Outcomes in Pediatric Acute Respiratory Distress Syndrome. Crit Care Med. 2021 May 1;49(5):816-827. doi: 10.1097/CCM.0000000000004819.
Natale JE, Asaro LA, Joseph JG, Ulysse C, Ascenzi J, Bowens C, Wypij D, Curley MAQ; RESTORE Study Investigators. Association of Race and Ethnicity with Sedation Management in Pediatric Intensive Care. Ann Am Thorac Soc. 2021 Jan;18(1):93-102. doi: 10.1513/AnnalsATS.201912-872OC.
Curley MAQ, Gedeit RG, Dodson BL, Amling JK, Soetenga DJ, Corriveau CO, Asario LA, Wypij D; RESTORE Investigative Team. Methods in the design and implementation of the Randomized Evaluation of Sedation Titration for Respiratory Failure (RESTORE) clinical trial. Trials. 2018 Dec 17;19(1):687. doi: 10.1186/s13063-018-3075-8.
Watson RS, Asaro LA, Hertzog JH, Sorce LR, Kachmar AG, Dervan LA, Angus DC, Wypij D, Curley MAQ; RESTORE Study Investigators and the Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network. Long-Term Outcomes after Protocolized Sedation versus Usual Care in Ventilated Pediatric Patients. Am J Respir Crit Care Med. 2018 Jun 1;197(11):1457-1467. doi: 10.1164/rccm.201708-1768OC.
Lebet R, Hayakawa J, Chamblee TB, Tala JA, Singh N, Wypij D, Curley MAQ. Maintaining Interrater Agreement of Core Assessment Instruments in a Multisite Randomized Controlled Clinical Trial: The Randomized Evaluation of Sedation Titration for Respiratory Failure (RESTORE) Trial. Nurs Res. 2017 Jul/Aug;66(4):323-329. doi: 10.1097/NNR.0000000000000224.
Natale JE, Lebet R, Joseph JG, Ulysse C, Ascenzi J, Wypij D, Curley MAQ; Randomized Evaluation of Sedation Titration for Respiratory Failure (RESTORE) Study Investigators. Racial and Ethnic Disparities in Parental Refusal of Consent in a Large, Multisite Pediatric Critical Care Clinical Trial. J Pediatr. 2017 May;184:204-208.e1. doi: 10.1016/j.jpeds.2017.02.006. Epub 2017 Mar 2.
Curley MA, Wypij D, Watson RS, Grant MJ, Asaro LA, Cheifetz IM, Dodson BL, Franck LS, Gedeit RG, Angus DC, Matthay MA; RESTORE Study Investigators and the Pediatric Acute Lung Injury and Sepsis Investigators Network. Protocolized sedation vs usual care in pediatric patients mechanically ventilated for acute respiratory failure: a randomized clinical trial. JAMA. 2015 Jan 27;313(4):379-89. doi: 10.1001/jama.2014.18399.
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