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

27. april 2026 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

2449

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

2 uger til 18 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Duration of mechanical ventilation
Tidsramme: 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)

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Pennsylvania

Samarbejdspartnere

National Heart, Lung, and Blood Institute (NHLBI)

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2009

Primær færdiggørelse (Faktiske)

1. december 2013

Studieafslutning (Faktiske)

1. december 2013

Datoer for studieregistrering

Først indsendt

19. december 2008

Først indsendt, der opfyldte QC-kriterier

19. december 2008

Først opslået (Anslået)

23. december 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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