Preventing Hypoxemia With Manual Ventilation During Endotracheal Intubation (PreVent) Trial (PreVent)
2018年9月12日 更新者：Matthew Semler、Vanderbilt University Medical Center
Complications are common during endotracheal intubation of critically ill adults.
Manual ventilation between induction and intubation ("bag-valve-mask" ventilation) has been proposed as a means of preventing hypoxemia, the most common complication of intubation outside the operating room.
Safety and efficacy data, however, are lacking.
PreVent is a randomized trial comparing manual ventilation between induction and laryngoscopy to no manual ventilation between induction an laryngoscopy during endotracheal intubation of critically ill adults.
The primary efficacy endpoint will be the lowest arterial oxygen saturation.
The primary safety endpoints will be the lowest oxygen saturation, highest fraction of inspired oxygen, and highest positive end-expiratory pressure in the 24 hours after the procedure.
調査の概要
詳細な説明
PreVent is a prospective, parallel-group, pragmatic, randomized trial comparing manual ventilation between induction and laryngoscopy to no manual ventilation between induction an laryngoscopy during endotracheal intubation of critically ill adults.
The primary aim of the PreVent trial is to compare the effect of manual ventilation between induction and intubation versus no manual ventilation on the lowest arterial oxygen saturation experienced by critically ill adults undergoing endotracheal intubation.
The PreVent trial is anticipated to begin enrollment in January 2017 and will enroll adults undergoing endotracheal intubation with sedation and/or neuromuscular blockade in participating units.
Patients will be randomized 1:1 to manual ventilation versus no manual ventilation.
In the manual ventilation group, manual ventilation using a bag-valve-mask will be provided from the time of induction until the time of endotracheal intubation, except during laryngoscopy.
In the no manual ventilation group, no manual ventilation will be provided between induction and endotracheal intubation, except for the treatment of hypoxemia.
The primary efficacy endpoint will be the lowest arterial oxygen saturation during the procedure.
The primary safety endpoints will be the lowest oxygen saturation, highest fraction of inspired oxygen, and highest positive end expiratory pressure in the 24 hours after intubation.
Conduct of the trial will be overseen by a Data Safety Monitoring Board.
An interim analysis will be performed after the enrollment of 175 patients.
The analysis of the trial will be conducted in accordance with a pre-specified statistical analysis plan made publicly available prior to the conclusion of enrollment.
The initial planned enrollment of 350 patients was increased by the Data and Safety Monitoring Board at the interim analysis to a final planned enrollment of 400 patients.
研究の種類
介入
入学 (実際)
401
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
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Alabama
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Birmingham、Alabama、アメリカ、35294
- The University of Alabama at Birmingham
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Louisiana
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New Orleans、Louisiana、アメリカ、70121
- Ochsner Health System
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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、37209
- Vanderbilt University Medical Center
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Washington
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Seattle、Washington、アメリカ、98104
- Harborview Medical Center, 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:
- Patient is located in a participating unit
- Planned procedure is endotracheal intubation
- Planned operator is a provider expected to routinely perform endotracheal intubation in the participating unit
- Administration of sedation and/or neuromuscular blockade is planned
- Age ≥ 18 years old
Exclusion Criteria:
- Urgency of intubation precludes safe performance of study procedures
- Operator feels a specific approach to ventilation between induction and intubation is required
- Pregnant women
- Prisoners
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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アクティブコンパレータ：Manual Ventilation
Beginning after the administration of sedation/neuromuscular blockade, manual ventilation will be provided by bag-valve-mask until the initiation of laryngoscopy.
In patients requiring more than one attempt at laryngoscopy, bag-valve-mask ventilation will resume between laryngoscopy attempts.
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Beginning after the administration of sedation/neuromuscular blockade, manual ventilation will be provided by bag-valve-mask until the initiation of laryngoscopy.
In patients requiring more than one attempt at laryngoscopy, bag-valve-mask ventilation will resume between laryngoscopy attempts.
他の名前：
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アクティブコンパレータ：No Manual Ventilation
Between the administration of sedation/neuromuscular blockade and intubation, ventilation will not be provided unless the patient experiences an arterial oxygen saturation less than 90%.
For patients who experience an oxygen saturation less than 90% after induction, bag-valve-mask ventilation may be provided.
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Between the administration of sedation/neuromuscular blockade and intubation, ventilation will not be provided unless the patient experiences an arterial oxygen saturation less than 90%.
For patients who experience an oxygen saturation less than 90% after induction, bag-valve-mask ventilation may be provided.
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
時間枠：Induction to 2 minutes after completion of the airway management procedure
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The lowest arterial oxygen saturation measured by continuous pulse oximetry (SpO2) between induction and 2 minutes after completion of the airway management procedure.
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Induction to 2 minutes after completion of the airway management procedure
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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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院内死亡率
時間枠：28日
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28日
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Incidence of lowest oxygen saturation less than 90%
時間枠：Induction to 2 minutes after completion of the airway management procedure
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Incidence of lowest oxygen saturation less than 90% in the time from induction to 2 minutes after completion of the airway management procedure.
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Induction to 2 minutes after completion of the airway management procedure
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Incidence of lowest oxygen saturation less than 80%
時間枠：Induction to 2 minutes after completion of the airway management procedure
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Incidence of lowest oxygen saturation less than 80% in the time from induction to 2 minutes after completion of the airway management procedure.
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Induction to 2 minutes after completion of the airway management procedure
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Change in saturation from induction to lowest oxygen saturation
時間枠：Induction to 2 minutes after completion of the airway management procedure
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Change in saturation from induction to lowest oxygen saturation within 2 minutes after completion of the airway management procedure.
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Induction to 2 minutes after completion of the airway management procedure
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Incidence of desaturation
時間枠：Induction to 2 minutes after completion of the airway management procedure
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Incidence of desaturation as defined by a decrease in oxygen saturation of greater than 3% from induction to lowest oxygen saturation within 2 minutes after completion of the airway management procedure.
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Induction to 2 minutes after completion of the airway management procedure
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Lowest oxygen saturation in the 24 hours after intubation.
時間枠：24 hours after intubation
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24 hours after intubation
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Highest fraction of inspired oxygen in the 24 hours after intubation.
時間枠：24 hours after intubation
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24 hours after intubation
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Highest positive end expiratory pressure in the 24 hours after intubation.
時間枠：24 hours after intubation
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24 hours after intubation
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Lowest oxygen saturation, highest fraction of inspired oxygen, and highest positive end expiratory pressure from 0-1, 1-6, and 6- 24 hours after intubation.
時間枠：24 hours after intubation
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Lowest oxygen saturation, highest fraction of inspired oxygen, and highest positive end expiratory pressure from 0-1, 1-6, and 6- 24 hours after intubation.
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24 hours after intubation
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Operator-reported pulmonary aspiration
時間枠：Induction to 2 minutes after completion of the airway management procedure
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Visualization of oropharyngeal or gastric contents in the pharynx, larynx, or trachea between induction and completion of airway management.
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Induction to 2 minutes after completion of the airway management procedure
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New infiltrate on chest imaging in the 48 hours after intubation
時間枠：48 hours after intubation
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Determination of new infiltrate will be made by two blinded experts (pulmonary/critical care attendings or fellows) with adjudication by a third expert in the case of discordant results
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48 hours after intubation
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Operator-reported pulmonary aspiration, new chest x-ray infiltrate, OR lowest oxygen saturation < 80% (composite outcome)
時間枠：48 hours after intubation
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48 hours after intubation
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New pneumothorax or pneumomediastinum on chest imaging in the 24 hours after intubation
時間枠：24 hours after intubation
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24 hours after intubation
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Incidence of esophageal intubation
時間枠：Induction to 2 minutes after completion of the airway management procedure
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Induction to 2 minutes after completion of the airway management procedure
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Lowest systolic blood pressure (peri-procedural)
時間枠：Induction to 2 minutes after completion of the airway management procedure
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Lowest systolic blood pressure between induction and two minutes after completion of the airway management procedure
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Induction to 2 minutes after completion of the airway management procedure
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New systolic blood pressure < 65 mmHg or new need for vasopressor
時間枠：Induction to 2 minutes after completion of the airway management procedure
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New systolic blood pressure < 65 mmHg or new need for vasopressor between medication administration and 2 minutes following successful placement of an endotracheal tube
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Induction to 2 minutes after completion of the airway management procedure
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Cardiac arrest within one hour of intubation
時間枠：One hour after intubation.
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One hour after intubation.
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Death within one hour of intubation
時間枠：One hour after intubation
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One hour after intubation
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Cormack-Lehane grade of glottic view
時間枠：Induction to 2 minutes after completion of the airway management procedure
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Induction to 2 minutes after completion of the airway management procedure
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Operator-assessed difficulty of intubation
時間枠：Induction to 2 minutes after completion of the airway management procedure
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Induction to 2 minutes after completion of the airway management procedure
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Incidence of successful intubation on the first laryngoscopy attempt
時間枠：Induction to 2 minutes after completion of the airway management procedure
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Induction to 2 minutes after completion of the airway management procedure
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Number of laryngoscopy attempts
時間枠：Induction to 2 minutes after completion of the airway management procedure
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Induction to 2 minutes after completion of the airway management procedure
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Time from induction to successful intubation
時間枠：Induction to 2 minutes after completion of the airway management procedure
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Induction to 2 minutes after completion of the airway management procedure
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Need for additional airway equipment or a second operator
時間枠：Induction to 2 minutes after completion of the airway management procedure
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Induction to 2 minutes after completion of the airway management procedure
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Ventilator-free days
時間枠：28 days
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Ventilator-free days to day 28 will be defined as the number of days alive and with unassisted breathing to day 28 after enrollment, assuming a patient survives for at least two consecutive calendar days after initiating unassisted breathing and remains free of assisted breathing.
If a patient returns to assisted breathing and subsequently achieves unassisted breathing prior to day 28, VFD will be counted from the end of the last period of assisted breathing to day 28.
If the patient is receiving assisted ventilation at day 28 or dies prior to day 28, VFD will be 0. If a patient is discharged while receiving assisted ventilation, VFD will be 0. All data will be censored at the first of hospital discharge or 28 days.
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28 days
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Intensive care unit-free days
時間枠：28 days
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ICU-free days to 28 days after enrollment will be defined as the number of days alive and not admitted to an intensive care unit service after the patient's final discharge from the intensive care unit in that hospitalization before 28 days.
Patients who are never discharged from the intensive care unit will receive a value of 0. Patients who die before day 28 will receive a value of 0. For patients who return to an ICU and are subsequently discharged prior to day 28, ICU-free days will be counted from the date of final ICU discharge.
All data will be censored at the first of hospital discharge or 28 days.
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28 days
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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。
捜査官
- 主任研究者：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
- Casey JD, Janz DR, Russell DW, Vonderhaar DJ, Joffe AM, Dischert KM, Brown RM, Zouk AN, Gulati S, Heideman BE, Lester MG, Toporek AH, Bentov I, Self WH, Rice TW, Semler MW; PreVent Investigators and the Pragmatic Critical Care Research Group. Bag-Mask Ventilation during Tracheal Intubation of Critically Ill Adults. N Engl J Med. 2019 Feb 28;380(9):811-821. doi: 10.1056/NEJMoa1812405. Epub 2019 Feb 18.
- Casey JD, Janz DR, Russell DW, Vonderhaar DJ, Joffe AM, Dischert KM, Brown RM, Lester MG, Zouk AN, Gulati S, Stigler WS, Rice TW, Semler MW; PreVent Investigators and the Pragmatic Critical Care Research Group. Manual ventilation to prevent hypoxaemia during endotracheal intubation of critically ill adults: protocol and statistical analysis plan for a multicentre randomised trial. BMJ Open. 2018 Aug 10;8(8):e022139. doi: 10.1136/bmjopen-2018-022139.
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 (実際)
2017年3月15日
一次修了 (実際)
2018年5月6日
研究の完了 (実際)
2018年7月6日
試験登録日
最初に提出
2017年1月16日
QC基準を満たした最初の提出物
2017年1月19日
最初の投稿 (見積もり)
2017年1月20日
学習記録の更新
投稿された最後の更新 (実際)
2018年9月13日
QC基準を満たした最後の更新が送信されました
2018年9月12日
最終確認日
2018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。
Manual Ventilationの臨床試験
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Krankenhaus BruneckMedical University Innsbruck完了