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

2026年4月27日更新者：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.

研究概览

地位

完全的

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (实际的)

2449

阶段

不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

2周至 18年 (孩子、成人)

接受健康志愿者

不

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：治疗
分配：随机化
介入模型：并行分配
屏蔽：无（打开标签）

手臂数量

武器和干预

参与者组/臂	干预/治疗
有源比较器：1 Participants will receive care at a pediatric ICU that is continuing the usual approach to sedation management.	行为的：Usual approach to sedation management The pediatric ICU will continue its usual approach to sedation management.
实验性的：2 Participants will receive care at a pediatric ICU that is implementing the team approach to sedation management.	行为的：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

参与者组/臂

干预/治疗

有源比较器：1

Participants will receive care at a pediatric ICU that is continuing the usual approach to sedation management.

行为的：Usual approach to sedation management

The pediatric ICU will continue its usual approach to sedation management.

实验性的：2

Participants will receive care at a pediatric ICU that is implementing the team approach to sedation management.

行为的：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

研究衡量的是什么？

主要结果指标

结果测量	大体时间
Duration of mechanical ventilation 大体时间：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)

次要结果测量

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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of Pennsylvania

合作者

National Heart, Lung, and Blood Institute (NHLBI)

调查人员

首席研究员：Martha A.Q. Curley, RN, PhD、University of Pennsylvania
研究主任：David Wypij, PhD、Director, Statistics and Data Coordinating Center; Children's Hospital Boston

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2009年1月1日

初级完成 (实际的)

2013年12月1日

研究完成 (实际的)

2013年12月1日

研究注册日期

首次提交

2008年12月19日

首先提交符合 QC 标准的

2008年12月19日

首次发布 (估计的)

2008年12月23日

研究记录更新

最后更新发布 (实际的)

2026年5月1日

上次提交的符合 QC 标准的更新

2026年4月27日

最后验证

2026年4月1日

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