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

27 april 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

2449

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

2 weken tot 18 jaar (Kind, Volwassen)

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 1
Participants will receive care at a pediatric ICU that is continuing the usual approach to sedation management.
Gedragsmatig: Usual approach to sedation management
The pediatric ICU will continue its usual approach to sedation management.
Experimenteel: 2
Participants will receive care at a pediatric ICU that is implementing the team approach to sedation management.
Gedragsmatig: 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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Duration of mechanical ventilation
Tijdsspanne: 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)

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Time to recovery of acute respiratory failure
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Measured for the duration of the study
Measured for the duration of the study
Detection of life-threatening neurological events
Tijdsspanne: Measured for the duration of the study
Measured for the duration of the study
Total sedative exposure
Tijdsspanne: Measured for the duration of the study
Measured for the duration of the study
Occurrence of iatrogenic withdrawal symptoms
Tijdsspanne: Measured for the duration of the study
Measured for the duration of the study
Pediatric ICU and hospital length of stay
Tijdsspanne: Measured for the duration of the study
Measured for the duration of the study
Hospital costs
Tijdsspanne: Measured for the duration of the study
Measured for the duration of the study
Study implementation costs and cost-effectiveness
Tijdsspanne: Measured for the duration of the study
Measured for the duration of the study
In-hospital mortality
Tijdsspanne: Measured for the duration of the study
Measured for the duration of the study
Post-discharge quality of life and emotional health
Tijdsspanne: Measured 6 months after pediatric ICU discharge
Measured 6 months after pediatric ICU discharge

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Pennsylvania

Medewerkers

National Heart, Lung, and Blood Institute (NHLBI)

Onderzoekers

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

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 januari 2009

Primaire voltooiing (Werkelijk)

1 december 2013

Studie voltooiing (Werkelijk)

1 december 2013

Studieregistratiedata

Eerst ingediend

19 december 2008

Eerst ingediend dat voldeed aan de QC-criteria

19 december 2008

Eerst geplaatst (Geschat)

23 december 2008

Updates van studierecords

Laatste update geplaatst (Werkelijk)

1 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

27 april 2026

Laatst geverifieerd

1 april 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 611
  • U01HL086622 (Subsidie/contract van de Amerikaanse NIH)
  • U01HL086649 (Subsidie/contract van de Amerikaanse NIH)

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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