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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.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (実際)

2449

段階

適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

2週間～18年 (子、大人)

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

主な目的：処理
割り当て：ランダム化
介入モデル：並列代入
マスキング：なし（オープンラベル）

アーム数

武器と介入

参加者グループ / アーム	介入・治療
アクティブコンパレータ：1 Participants will receive care at a pediatric ICU that is continuing the usual approach to sedation management.	行動：Usual approach to sedation management The pediatric ICU will continue its usual approach to sedation management.
実験的：2 Participants will receive care at a pediatric ICU that is implementing the team approach to sedation management.	行動：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

参加者グループ / アーム

介入・治療

アクティブコンパレータ：1

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

行動：Usual approach to sedation management

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

実験的：2

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

行動：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

この研究は何を測定していますか？

主要な結果の測定

結果測定	時間枠
Duration of mechanical ventilation 時間枠：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)

二次結果の測定

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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

University of Pennsylvania

協力者

National Heart, Lung, and Blood Institute (NHLBI)

捜査官

主任研究者：Martha A.Q. Curley, RN, PhD、University of Pennsylvania
スタディディレクター：David Wypij, PhD、Director, Statistics and Data Coordinating Center; Children's Hospital Boston

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2009年1月1日

一次修了 (実際)

2013年12月1日

研究の完了 (実際)

2013年12月1日

試験登録日

最初に提出

2008年12月19日

QC基準を満たした最初の提出物

2008年12月19日

最初の投稿 (推定)

2008年12月23日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月1日

QC基準を満たした最後の更新が送信されました

2026年4月27日

最終確認日

2026年4月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

611
U01HL086622 (米国 NIH グラント/契約)
U01HL086649 (米国 NIH グラント/契約)

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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