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

27 avril 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

2449

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

2 semaines à 18 ans (Enfant, Adulte)

Accepte les volontaires sains

Non

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: 1
Participants will receive care at a pediatric ICU that is continuing the usual approach to sedation management.
Comportemental: Usual approach to sedation management
The pediatric ICU will continue its usual approach to sedation management.
Expérimental: 2
Participants will receive care at a pediatric ICU that is implementing the team approach to sedation management.
Comportemental: 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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
Duration of mechanical ventilation
Délai: 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)

Mesures de résultats secondaires

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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Pennsylvania

Collaborateurs

National Heart, Lung, and Blood Institute (NHLBI)

Les enquêteurs

  • Chercheur principal: Martha A.Q. Curley, RN, PhD, University of Pennsylvania
  • Directeur d'études: David Wypij, PhD, Director, Statistics and Data Coordinating Center; Children's Hospital Boston

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 janvier 2009

Achèvement primaire (Réel)

1 décembre 2013

Achèvement de l'étude (Réel)

1 décembre 2013

Dates d'inscription aux études

Première soumission

19 décembre 2008

Première soumission répondant aux critères de contrôle qualité

19 décembre 2008

Première publication (Estimé)

23 décembre 2008

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

1 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

27 avril 2026

Dernière vérification

1 avril 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 611
  • U01HL086622 (Subvention/contrat des NIH des États-Unis)
  • U01HL086649 (Subvention/contrat des NIH des États-Unis)

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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