Checklists and Upright Positioning in Endotracheal Intubation of Critically Ill Patients (Check-UP) Trial (Check-UP)
2016年9月16日 更新者：Todd Rice、Vanderbilt University
The use of a written, pre-procedure checklist and positioning the patient with the head of the bed elevated have been proposed as interventions capable of preventing complications during non-elective intubation and are used intermittently in routine care -- however neither have been examined in a prospective trial.
調査の概要
詳細な説明
Endotracheal intubation is common in the care of critically ill patients.
Procedural complications including hypoxia and hypotension are frequent in urgent and emergent intubation and associated with an increased risk of death.
The use of a written, pre-procedure checklist and positioning the patient with the head of the bed elevated have been proposed as interventions capable of preventing complications during non-elective intubation and are used intermittently in routine care -- however neither have been examined in a prospective trial.
The investigators propose a randomized trial comparing use of a written checklist versus no written checklist and ramped versus sniffing position for endotracheal intubation of critically ill adults.
研究の種類
介入
入学 (実際)
260
段階
- フェーズ 4
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
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Alabama
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Birmingham、Alabama、アメリカ、35294
- University of Alabama - Birmingham
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Louisiana
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New Orleans、Louisiana、アメリカ、70115
- Ochsner Medical Center
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New Orleans、Louisiana、アメリカ、70112
- Louisiana State University School of Medicine
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Tennessee
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Nashville、Tennessee、アメリカ、37232
- Vanderbilt University
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Washington
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Seattle、Washington、アメリカ、98104
- University of Washington
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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
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
Airway management events will be included in which:
- Patient is admitted to the Medical Intensive Care Unit (MICU)
- Planned procedure is endotracheal intubation
- Planned operator is a Pulmonary and Critical Care Medicine (PCCM) fellow
- Administration of sedation and/or neuromuscular blockade is planned
- Age ≥ 18 years old
Exclusion Criteria:
Airway management events will be excluded in which:
- Operator feels specific patient positioning during intubation is required
- Urgency of intubation precludes safe performance of study procedures
- Operator feels an alternative pre-procedure checklist or no checklist is required
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：防止
- 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）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：Sniffing Position, No Checklist
Patient in the sniffing position without the use of a written checklist
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アクティブコンパレータ：Sniffing Position, Checklist
Patient in the sniffing position with the use of a written checklist
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Use of a written checklist pre and peri-intubation
他の名前：
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アクティブコンパレータ：Head of Bed Up, No Checklist
Patient with the head of bed up and without the use of a checklist
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Raising the patient's head of bed to 25 degrees
他の名前：
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アクティブコンパレータ：Head of Bed Up, Checklist
Patient with the head of bed up and with the use of a checklist
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Use of a written checklist pre and peri-intubation
他の名前：
Raising the patient's head of bed to 25 degrees
他の名前：
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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 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Lowest Arterial Oxygen Saturation (Both positioning and Checklist interventions)
時間枠：Time of Induction through 2 minutes after successful intubation
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Lowest non-invasively measured arterial oxygen saturation between the time of induction or neuromuscular blockade and two minutes after completion of the airway management procedure
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Time of Induction through 2 minutes after successful intubation
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Lowest Systolic Blood Pressure (Checklist intervention only)
時間枠：Time of Induction through 2 minutes after successful intubation
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Lowest non-invasively or invasively measured systolic blood pressure between medication administration and 2 minutes following successful placement of an endotracheal tube (in checklist comparison only)
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Time of Induction through 2 minutes after successful intubation
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Incidence of Desaturation
時間枠：Time of Induction through 2 minutes after successful intubation
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Decrease in oxygen saturation of greater than 3% from induction to lowest oxygen saturation
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Time of Induction through 2 minutes after successful intubation
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Incidence of Hypoxemia
時間枠：Time of Induction through 2 minutes after successful intubation
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Defined by lowest oxygen saturation less than 90% and severe hypoxemia as defined by lowest oxygen saturation less than 80%
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Time of Induction through 2 minutes after successful intubation
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Change in Saturation
時間枠：Time of Induction through 2 minutes after successful intubation
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Change in oxygen saturation from baseline to lowest oxygen saturation
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Time of Induction through 2 minutes after successful intubation
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Grade of First Glottic View
時間枠：Time of Induction through 2 minutes after successful intubation
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Cormack-Lehane grade of view on first intubation attempt
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Time of Induction through 2 minutes after successful intubation
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First Pass Success
時間枠：Time of Induction through 2 minutes after successful intubation
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Placement of an endotracheal tube in the trachea after the first insertion of the laryngoscope into the oral cavity without the use of any other devices
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Time of Induction through 2 minutes after successful intubation
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Number of Intubation Attempts
時間枠：Time of Induction through 2 minutes after successful intubation
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Number of attempts required for successful tube placement
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Time of Induction through 2 minutes after successful intubation
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Time to Intubation
時間枠：Time of Induction through 2 minutes after successful intubation
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Time (in minutes) from pushing of induction meds to successful placement of endotracheal tube
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Time of Induction through 2 minutes after successful intubation
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Need for Assistance
時間枠：Time of Induction through 2 minutes after successful intubation
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Incidence of need for additional intubating equipment, second operator
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Time of Induction through 2 minutes after successful intubation
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Non-hypoxic complications
時間枠：Time of Induction through 2 minutes after successful intubation
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Incidence of non-oxygenation complications - composite of all other recorded complications
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Time of Induction through 2 minutes after successful intubation
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Malposition of Endotracheal Tube
時間枠：Time of Induction through 2 minutes after successful intubation
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Incidence of post-intubation tube malposition on Chest X-Ray (CXR)
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Time of Induction through 2 minutes after successful intubation
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Repositioning Patient
時間枠：Time of Induction through 2 minutes after successful intubation
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Incidence of repositioning patient after procedure initiation
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Time of Induction through 2 minutes after successful intubation
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In-Hospital Mortality
時間枠：From enrollment through the earlier of hospital discharge or 365 days
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Death before hospital discharge
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From enrollment through the earlier of hospital discharge or 365 days
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Ventilator-free Days
時間枠：From enrollment through study day 28
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Days alive and free from mechanical ventilation
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From enrollment through study day 28
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ICU-Free Days
時間枠：From enrollment through study day 28
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Days alive and out of the ICU
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From enrollment through study day 28
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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
捜査官
- スタディディレクター：Todd W Rice, MD, MSc、Vanderbilt University Medical Center
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
- Janz DR, Semler MW, Joffe AM, Casey JD, Lentz RJ, deBoisblanc BP, Khan YA, Santanilla JI, Bentov I, Rice TW; Check-UP Investigators*; Pragmatic Critical Care Research Group. A Multicenter Randomized Trial of a Checklist for Endotracheal Intubation of Critically Ill Adults. Chest. 2018 Apr;153(4):816-824. doi: 10.1016/j.chest.2017.08.1163. Epub 2017 Sep 14.
- Semler MW, Janz DR, Russell DW, Casey JD, Lentz RJ, Zouk AN, deBoisblanc BP, Santanilla JI, Khan YA, Joffe AM, Stigler WS, Rice TW; Check-UP Investigators( *); Pragmatic Critical Care Research Group. A Multicenter, Randomized Trial of Ramped Position vs Sniffing Position During Endotracheal Intubation of Critically Ill Adults. Chest. 2017 Oct;152(4):712-722. doi: 10.1016/j.chest.2017.03.061. Epub 2017 May 6.
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
2015年7月1日
一次修了 (実際)
2016年9月1日
研究の完了 (実際)
2016年9月1日
試験登録日
最初に提出
2015年7月6日
QC基準を満たした最初の提出物
2015年7月10日
最初の投稿 (見積もり)
2015年7月14日
学習記録の更新
投稿された最後の更新 (見積もり)
2016年9月19日
QC基準を満たした最後の更新が送信されました
2016年9月16日
最終確認日
2016年9月1日
詳しくは
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。