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

27 aprile 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

2449

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 2 settimane a 18 anni (Bambino, Adulto)

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 1
Participants will receive care at a pediatric ICU that is continuing the usual approach to sedation management.
Comportamentale: Usual approach to sedation management
The pediatric ICU will continue its usual approach to sedation management.
Sperimentale: 2
Participants will receive care at a pediatric ICU that is implementing the team approach to sedation management.
Comportamentale: 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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Duration of mechanical ventilation
Lasso di tempo: 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)

Misure di risultato secondarie

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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Pennsylvania

Collaboratori

National Heart, Lung, and Blood Institute (NHLBI)

Investigatori

  • Investigatore principale: Martha A.Q. Curley, RN, PhD, University of Pennsylvania
  • Direttore dello studio: David Wypij, PhD, Director, Statistics and Data Coordinating Center; Children's Hospital Boston

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 gennaio 2009

Completamento primario (Effettivo)

1 dicembre 2013

Completamento dello studio (Effettivo)

1 dicembre 2013

Date di iscrizione allo studio

Primo inviato

19 dicembre 2008

Primo inviato che soddisfa i criteri di controllo qualità

19 dicembre 2008

Primo Inserito (Stimato)

23 dicembre 2008

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

1 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

27 aprile 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 611
  • U01HL086622 (Sovvenzione/contratto NIH degli Stati Uniti)
  • U01HL086649 (Sovvenzione/contratto NIH degli Stati Uniti)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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