The NEUROlogically-impaired Extubation Timing Trial (NEURO-ETT)
2020年2月3日 更新者：Dr. Damon Scales、Sunnybrook Health Sciences Centre
This randomized controlled trial will enrol patients with acute severe brain injury who pass a spontaneous breathing trial but have decreased level of consciousness.
It will directly compare (1) prompt extubation vs. (2) usual care, with extubation or tracheostomy timed according to physicians' discretion.
The primary outcome will be ICU free days (days spent alive and outside an ICU).
調査の概要
詳細な説明
Thousands of patients suffer severe brain injuries every year, from causes such as trauma, stroke, and infection.
Extensive clinical research in weaning from mechanical ventilation has led to recommendations for prompt extubation following a successful trial of spontaneous breathing in general intensive care unit (ICU).
However, little evidence exists to guide decisions about when to remove the breathing tube in patients with severe brain injury.
It is unclear which of the following strategies would optimize important patient outcomes: prompt extubation vs. waiting and extubating or performing a tracheostomy, timed according to physicians' discretion.
Each strategy has associated risks: prompt extubation may lead to higher rates of extubation failure and reintubation, whereas waiting longer may expose patients to complications from prolonged mechanical ventilation and tracheostomy may lead to procedural complications (or unnecessary procedures, if prompt extubation would be successful).
This trial in brain-injured patients will test which of the following will lead to better patient outcomes: (1) removing the endotracheal tube promptly once a spontaneous breathing trial is passed; or (2) usual care, with the airway management strategy selected according to the preference of the treating physician.
研究の種類
介入
入学 (実際)
27
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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Alberta
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Edmonton、Alberta、カナダ、T6G 2B7
- University of Alberta Hospital
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British Columbia
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New Westminster、British Columbia、カナダ、V3L 3W7
- Royal Columbian Hospital
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Vancouver、British Columbia、カナダ、V5Z 1M9
- Vancouver General Hospital
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Ontario
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Hamilton、Ontario、カナダ、L8N 3Z5
- Hamilton General Hospital
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Kingston、Ontario、カナダ、K7L 2V7
- Kingston General Hospital
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London、Ontario、カナダ、N6A 5A5
- London Health Sciences Centre
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Ottawa、Ontario、カナダ、K1H 8L6
- Ottawa Hospital
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Toronto、Ontario、カナダ、M4N 3M5
- Sunnybrook Health Sciences Centre
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Toronto、Ontario、カナダ、M5B 1W8
- St. Michael's Hospital
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Toronto、Ontario、カナダ、M5G 2N2
- Toronto Western Hospital
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Quebec
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Montreal、Quebec、カナダ、H4J 1C5
- Hôpital du Sacré-Coeur de Montréal
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Montreal、Quebec、カナダ、H2X 2H8
- Centre Hospitalier de l'Universite de Montreal
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Quebec City、Quebec、カナダ、G1J 1Z4
- L'Hôpital de l'Enfant-Jésus
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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
16年歳以上 (子、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:
- Age > 16 years
- Acute brain injury (subarachnoid hemorrhage, ischemic stroke, spontaneous intracerebral hemorrhage, seizure, traumatic brain injury, brain tumor, global cerebral anoxia/cardiac arrest, meningitis/encephalitis/cerebral abscess) that occurred within the previous 4 weeks.
- Receiving invasive mechanical ventilation via endotracheal tube for > 72 hours
- Glasgow Coma Scale motor score 3 to 6 with improvement or no change from previous day
- passed spontaneous breathing trial (SBT)
Exclusion Criteria:
- Previous extubation during this ICU admission
- Quadriplegic
- Neuromuscular disease that will result in prolong need for mechanical ventilation, including but not limited to Guillain-Barre syndrome, cervical spinal cord injury, advanced multiple sclerosis
- Do-Not-Reintubate order in place
- Previously randomized in this trial
- Underlying pre-existing condition with expected mortality less than 6-months.
- Anticipated/scheduled for surgical procedures within 48 hours
- C-spine not yet cleared for activity as tolerated (cleared for activity as tolerated while wearing hard collar is acceptable)
- Currently known or suspected to have an difficult airway
- Absence of an endotracheal tube cuff leak, if checked
- Absence of spontaneous or induced cough
- Current enrolment in an RCT that precludes NEURO-ETT co-enrollment
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：ヘルスサービス研究
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
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：Extubation
Extubation by removal of endotracheal tube.
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This is an extubation by removal of endotracheal tube which must be done on the day of randomization or the following day.
Any decision to subsequently reintubate the patient will be left to the discretion of the clinical team.
Similarly, if a tracheostomy is deemed necessary in a patient who fails the extubation attempt, this will be managed at the discretion of the treating team.
If for any reason the patient is not extubated according to the randomized schedule, the reason(s) will be recorded on a protocol violation form and the site investigator will be notified.
If a patient receives a tracheostomy instead of being extubated we will again record reasons for this, but the patient will be analysed in the extubation group according to the intention-to-treat principle.
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アクティブコンパレータ：Usual care
The usual clinical practice is removal of the endotracheal tube (extubation), or insertion of tracheostomy, timed according to physicians' discretion
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Patients in this group will be treated according to usual care, which may include extubation (removal of endotracheal tube) or insertion of a tracheostomy, timed according to physicians' discretion.
The inclusion of this arm will allow prompt extubation to be compared to usual practice, which often involves further observation and delayed decision-making due to clinician uncertainty about the optimal airway management strategy.
Incorporation of usual care arms has been promoted as a design feature to improve the safety and interpretability of critical care clinical trials.
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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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ICU Free Days
時間枠：60 days
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The primary outcome is number of ICU free days to day 60, defined as the number of days spent alive and outside of an ICU until day 60. The primary outcome will be measured to answer the following primary question: Among patients receiving minimal mechanical ventilatory support for severe and persistent brain injury, which of the following airway management strategies increase ICU-free days to day 60: (1) prompt extubation vs. (2) usual care, which may include extubation or tracheostomy timed according to physicians' discretion? |
60 days
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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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Mortality,
時間枠：up to 6 months
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Mortality at ICU discharge, mortality at hospital discharge, mortality at 3 months, mortality at 6 months
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up to 6 months
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Ventilator-Free Days
時間枠：up to 60 days
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Days free of mechanical ventilation, total duration (days) of ventilation among survivors
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up to 60 days
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Airway Complications
時間枠：up to 60 days
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Presence versus absence of airway complication
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up to 60 days
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Nutrition Intake
時間枠：up to 6 months
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Time to normal oral nutrition intake
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up to 6 months
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Antibiotic Days
時間枠：up to day 14
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Injection or infusion of antibiotics given intravenously
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up to day 14
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Delirium
時間枠：up to day 14
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Presence versus absence of delirium experienced
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up to day 14
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Rate of Tracheostomy Insertion
時間枠：up to 6 months
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Presence versus absence of tracheostomy insertion
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up to 6 months
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Rate of ICU Readmission
時間枠：up to hospital discharge
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ICU readmission rates to hospital discharge
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up to hospital discharge
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Hospital Discharge Destination
時間枠：at hospital discharge
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Destination of the patient post hospitalization - home, rehabilitation facility, retirement home, long-term care/nursing home, no fixed address or shelter, continuing complex care, acute care hospital, other
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at hospital discharge
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Extended Glasgow Outcome Score
時間枠：up to 6 months
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Functional outcome (scoring 1 to 8)
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up to 6 months
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EQ-5D
時間枠：up to 6 months
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Health related quality of life (scoring 1 to 5)
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up to 6 months
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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：Damon Scales, MD, PhD、Sunnybrook Health Sciences Centre
- 主任研究者：Niall Ferguson, MD, MSc,、Toronto General Hospital
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2月1日
一次修了 (実際)
2019年6月19日
研究の完了 (予想される)
2022年1月31日
試験登録日
最初に提出
2016年9月22日
QC基準を満たした最初の提出物
2016年9月28日
最初の投稿 (見積もり)
2016年9月30日
学習記録の更新
投稿された最後の更新 (実際)
2020年2月5日
QC基準を満たした最後の更新が送信されました
2020年2月3日
最終確認日
2020年2月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- NEURO-ETT (Vanguard)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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