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

December 19, 2008
June 13, 2012
January 2009
December 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00814099 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Sedation Management in Pediatric Patients With Acute Respiratory Failure (The RESTORE Study)
Sedation Management in Pediatric Patients With Acute Respiratory Failure

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Respiratory Insufficiency
  • Respiratory Distress Syndrome, Newborn
  • Lung Diseases
  • 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
  • Behavioral: Usual approach to sedation management
    The pediatric ICU will continue its usual approach to sedation management.
  • Active Comparator: 1
    Participants will receive care at a pediatric ICU that is continuing the usual approach to sedation management.
    Intervention: Behavioral: Usual approach to sedation management
  • Experimental: 2
    Participants will receive care at a pediatric ICU that is implementing the team approach to sedation management.
    Intervention: Behavioral: Team approach to sedation management
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
2448
March 2013
December 2012   (final data collection date for primary outcome measure)

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
Both
up to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00814099
611, U01HL086622, U01 HL086649, U01 HL086622
Yes
University of Pennsylvania
University of Pennsylvania
National Heart, Lung, and Blood Institute (NHLBI)
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
University of Pennsylvania
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP