Sedation Management in Pediatric Patients With Acute Respiratory Failure (The RESTORE Study)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00814099
First received: December 19, 2008
Last updated: June 13, 2012
Last verified: June 2012
  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

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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:

  • 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

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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00814099

  Hide Study Locations
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
Sponsors and Collaborators
University of Pennsylvania
Investigators
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:
Respiratory Distress Syndrome, Newborn
Respiratory Insufficiency
Lung Diseases
Respiratory Distress Syndrome, Adult
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on September 22, 2014