Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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

27. april 2026 oppdatert 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

2449

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

2 uker til 18 år (Barn, Voksen)

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

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

Hva måler studien?

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Pennsylvania

Samarbeidspartnere

National Heart, Lung, and Blood Institute (NHLBI)

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. januar 2009

Primær fullføring (Faktiske)

1. desember 2013

Studiet fullført (Faktiske)

1. desember 2013

Datoer for studieregistrering

Først innsendt

19. desember 2008

Først innsendt som oppfylte QC-kriteriene

19. desember 2008

Først lagt ut (Antatt)

23. desember 2008

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

1. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

27. april 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere