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

27 april 2026 uppdaterad av: University of Pennsylvania

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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

2449

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Alabama
      • Birmingham, Alabama, Förenta staterna, 35233
        • Children's Hospital of Alabama
    • Arizona
      • Tucson, Arizona, Förenta staterna, 85724
        • University Medical Center, The University of Arizona
    • California
      • Oakland, California, Förenta staterna, 94609-1809
        • Children's Hospital and Research Center at Oakland
      • Orange, California, Förenta staterna, 92868
        • Children's Hospital of Orange County
      • Palo Alto, California, Förenta staterna, 94304-0126
        • Lucile Salter Packard Children's Hospital at Stanford
      • Sacramento, California, Förenta staterna, 95817
        • University of California Davis Medical Center
      • San Francisco, California, Förenta staterna, 94143
        • Children's Hospital at University of California San Francisco Medical Center
    • Connecticut
      • Hartford, Connecticut, Förenta staterna, 06106
        • Connecticut Children's Medical Center
      • New Haven, Connecticut, Förenta staterna, 06520-8064
        • Yale-New Haven Children's Hospital
    • Delaware
      • Wilmington, Delaware, Förenta staterna, 19803
        • Nemours/Alfred I. duPont Hospital for Children
    • Florida
      • Miami, Florida, Förenta staterna, 33136
        • Holtz Children's Hospital
      • Orlando, Florida, Förenta staterna, 32803
        • Florida Hospital for Children
    • Illinois
      • Chicago, Illinois, Förenta staterna, 60614-3363
        • Children's Memorial Hospital, Chicago
      • Oak Lawn, Illinois, Förenta staterna, 60453
        • Advocate Hope Children's Hospital
    • Maryland
      • Baltimore, Maryland, Förenta staterna, 21287
        • Johns Hopkins Children's Center
      • Baltimore, Maryland, Förenta staterna, 21201-1595
        • University of Maryland Hospital for Children
    • Massachusetts
      • Worcester, Massachusetts, Förenta staterna, 01655
        • University of Massachusetts Memorial Children's Medical Center
    • Michigan
      • Ann Arbor, Michigan, Förenta staterna, 48109-0243
        • C. S. Mott Children's Hospital of the University of Michigan
    • Missouri
      • Kansas City, Missouri, Förenta staterna, 84108
        • Children's Mercy Hospital, Kansas City
      • St Louis, Missouri, Förenta staterna, 63110
        • St. Louis Children's Hospital
    • Nebraska
      • Omaha, Nebraska, Förenta staterna, 68114
        • University of Nebraska Medical Center
    • New Hampshire
      • Lebanon, New Hampshire, Förenta staterna, 03756-0001
        • Dartmouth-Hitchcock Medical Center
    • New York
      • New Hyde Park, New York, Förenta staterna, 11040
        • Cohen Children's Medical Center of New York
      • The Bronx, New York, Förenta staterna, 10467
        • The Children's Hospital at Montefiore
    • North Carolina
      • Durham, North Carolina, Förenta staterna, 27710
        • Duke Children's Hospital and Health Center
    • Oregon
      • Portland, Oregon, Förenta staterna, 97239
        • Doernbecher Children's Hospital
    • Pennsylvania
      • Philadelphia, Pennsylvania, Förenta staterna, 19104
        • Children's Hospital of Philadelphia
    • Tennessee
      • Nashville, Tennessee, Förenta staterna, 37232-9075
        • Monroe Carell, Jr. Children's Hospital at Vanderbilt
    • Texas
      • Dallas, Texas, Förenta staterna, 75235
        • Children's Medical Center Dallas
      • Dallas, Texas, Förenta staterna, 75230
        • Medical City Children's Hospital
    • Utah
      • Salt Lake City, Utah, Förenta staterna, 84113
        • Primary Children's Medical Center

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

2 veckor till 18 år (Barn, Vuxen)

Tar emot friska volontärer

Nej

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: 1
Participants will receive care at a pediatric ICU that is continuing the usual approach to sedation management.
Beteende: Usual approach to sedation management
The pediatric ICU will continue its usual approach to sedation management.
Experimentell: 2
Participants will receive care at a pediatric ICU that is implementing the team approach to sedation management.
Beteende: 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

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Duration of mechanical ventilation
Tidsram: Measured from the time of endotracheal intubation to the end of scheduled sedation therapy, hospital discharge, or Day 28 (whichever comes first)
Measured from the time of endotracheal intubation to the end of scheduled sedation therapy, hospital discharge, or Day 28 (whichever comes first)

Sekundära resultatmått

Resultatmått
Tidsram
Time to recovery of acute respiratory failure
Tidsram: Measured from the time of endotracheal intubation to when participants first meet the criteria to be tested for extubation readiness
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
Tidsram: 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)
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
Tidsram: Measured for the duration of the study
Measured for the duration of the study
Detection of life-threatening neurological events
Tidsram: Measured for the duration of the study
Measured for the duration of the study
Total sedative exposure
Tidsram: Measured for the duration of the study
Measured for the duration of the study
Occurrence of iatrogenic withdrawal symptoms
Tidsram: Measured for the duration of the study
Measured for the duration of the study
Pediatric ICU and hospital length of stay
Tidsram: Measured for the duration of the study
Measured for the duration of the study
Hospital costs
Tidsram: Measured for the duration of the study
Measured for the duration of the study
Study implementation costs and cost-effectiveness
Tidsram: Measured for the duration of the study
Measured for the duration of the study
In-hospital mortality
Tidsram: Measured for the duration of the study
Measured for the duration of the study
Post-discharge quality of life and emotional health
Tidsram: Measured 6 months after pediatric ICU discharge
Measured 6 months after pediatric ICU discharge

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of Pennsylvania

Samarbetspartners

National Heart, Lung, and Blood Institute (NHLBI)

Utredare

  • Huvudutredare: Martha A.Q. Curley, RN, PhD, University of Pennsylvania
  • Studierektor: David Wypij, PhD, Director, Statistics and Data Coordinating Center; Children's Hospital Boston

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 januari 2009

Primärt slutförande (Faktisk)

1 december 2013

Avslutad studie (Faktisk)

1 december 2013

Studieregistreringsdatum

Först inskickad

19 december 2008

Först inskickad som uppfyllde QC-kriterierna

19 december 2008

Första postat (Beräknad)

23 december 2008

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

1 maj 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

27 april 2026

Senast verifierad

1 april 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 611
  • U01HL086622 (U.S.S. NIH-anslag/kontrakt)
  • U01HL086649 (U.S.S. NIH-anslag/kontrakt)

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