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

27 de abril de 2026 atualizado por: 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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

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 de estudo

Intervencional

Inscrição (Real)

2449

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

2 semanas a 18 anos (Filho, Adulto)

Aceita Voluntários Saudáveis

Não

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: 1
Participants will receive care at a pediatric ICU that is continuing the usual approach to sedation management.
Comportamental: Usual approach to sedation management
The pediatric ICU will continue its usual approach to sedation management.
Experimental: 2
Participants will receive care at a pediatric ICU that is implementing the team approach to sedation management.
Comportamental: 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

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Prazo
Duration of mechanical ventilation
Prazo: 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)

Medidas de resultados secundários

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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

University of Pennsylvania

Colaboradores

National Heart, Lung, and Blood Institute (NHLBI)

Investigadores

  • Investigador principal: Martha A.Q. Curley, RN, PhD, University of Pennsylvania
  • Diretor de estudo: David Wypij, PhD, Director, Statistics and Data Coordinating Center; Children's Hospital Boston

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de janeiro de 2009

Conclusão Primária (Real)

1 de dezembro de 2013

Conclusão do estudo (Real)

1 de dezembro de 2013

Datas de inscrição no estudo

Enviado pela primeira vez

19 de dezembro de 2008

Enviado pela primeira vez que atendeu aos critérios de CQ

19 de dezembro de 2008

Primeira postagem (Estimado)

23 de dezembro de 2008

Atualizações de registro de estudo

Última Atualização Postada (Real)

1 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

27 de abril de 2026

Última verificação

1 de abril de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 611
  • U01HL086622 (Concessão/Contrato do NIH dos EUA)
  • U01HL086649 (Concessão/Contrato do NIH dos EUA)

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