Effect of High-Flow Humidified Oxygen on Ventilatory Work During the Spontaneous Breathing Trial (OTRAVAIL)
2026年7月20日 更新者：University Hospital, Grenoble
Weaning from mechanical ventilation (MV) accounts for a significant portion of the total MV duration, and failure to extubate or delayed extubation increases complications (particularly Ventilator-Associated Pneumonia (VAP)) and mortality. Standard tests (T-piece, Spontaneous Ventilation with Inspiratory Assistance (SV-IA)) have not demonstrated clear superiority, and the T-piece is still widely used despite its limitations. High-flow oxygen (HFO) may reduce ventilatory work and facilitate secretion clearance; however, there is a lack of physiological data in humans with an endotracheal tube in place. This study aims to address this gap prior to a subsequent clinical evaluation.
An experimental, prospective, single-center, 3-period crossover study with randomized sequence order and single-blind design (primary endpoint assessment and statistical analysis were conducted in a blinded manner).
調査の概要
研究の種類
介入
入学 (推定)
30
段階
- 適用できない
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
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Adult patient, of legal age
- On invasive mechanical ventilation for more than 48 hours
With at least one criterion indicating a high risk of extubation failure:
- Age > 65 years
- Chronic respiratory disease
- Chronic cardiac disease
Capable of undergoing a mechanical ventilation weaning test ("weaning criterion"):
- Respiratory rate < 35 bpm
Adequate oxygenation:
- SpO₂ ≥ 90% with FiO₂ ≤ 40% and PEEP ≤ 8 cm H₂O
- Or PaO₂/FiO₂ ≥ 150 with PEEP ≤ 8 cm H₂O
- Effective cough
- Patient is alert (RASS score -2 to +1), without sedation
- Hemodynamically stable or on the minimum effective dose
- Patient has an invasive arterial pressure catheter for arterial blood sampling
- Informed consent signed by a family member
- Patient is enrolled in or eligible for a social security program
Exclusion Criteria:
- Resuscitation-associated neuromyopathy
- History of neuromuscular disease
- Admission for a neurological condition
- Subjects currently excluded from another study,
- Persons referred to in Articles L1121-5 through L1121-8 of the CSP (corresponding to all protected persons: pregnant women, women in labor, breastfeeding mothers, persons deprived of liberty by judicial or administrative decision, persons receiving psychiatric care pursuant to Articles L. 3212-1 and L. 3213-1 who are not covered by the provisions of Article L. 1121-8, persons admitted to a health or social care facility for purposes other than research, minors, and persons subject to a legal protection order or unable to give informed consent).
- Staff members who report to the principal investigator
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：クロスオーバー割り当て
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：TP/HFO/PSV
T piece follow by HFO follow by PSV
|
The endotracheal tube will be disconnected from the ventilator, and a T-piece (Teleflex, Trach-Vent +®) with oxygen delivery
The endotracheal tube will be connected to the pneumotachograph.
The ventilator settings will be adjusted as follows: VS mode, inspiratory support at 7 cmH₂O, PEEP at 0 cmH₂O.
The endotracheal tube will be disconnected from the ventilator, and an OHD delivery device normally used for tracheostomies (Fisher & Paykel, Optiflow+®) will be connected to the pneumotachograph.
The OHD flow rate will be set to 50 L/min.
A Monnal T60 ventilator (Air Liquide Healthcare) will be used for OHD administration.
|
|
他の：TP/PSV/HFO
T piece follow by PSV follow by HFO
|
The endotracheal tube will be disconnected from the ventilator, and a T-piece (Teleflex, Trach-Vent +®) with oxygen delivery
The endotracheal tube will be connected to the pneumotachograph.
The ventilator settings will be adjusted as follows: VS mode, inspiratory support at 7 cmH₂O, PEEP at 0 cmH₂O.
The endotracheal tube will be disconnected from the ventilator, and an OHD delivery device normally used for tracheostomies (Fisher & Paykel, Optiflow+®) will be connected to the pneumotachograph.
The OHD flow rate will be set to 50 L/min.
A Monnal T60 ventilator (Air Liquide Healthcare) will be used for OHD administration.
|
|
他の：PSV/HFO/TP
PSV follow by HFO follow by T piece
|
The endotracheal tube will be disconnected from the ventilator, and a T-piece (Teleflex, Trach-Vent +®) with oxygen delivery
The endotracheal tube will be connected to the pneumotachograph.
The ventilator settings will be adjusted as follows: VS mode, inspiratory support at 7 cmH₂O, PEEP at 0 cmH₂O.
The endotracheal tube will be disconnected from the ventilator, and an OHD delivery device normally used for tracheostomies (Fisher & Paykel, Optiflow+®) will be connected to the pneumotachograph.
The OHD flow rate will be set to 50 L/min.
A Monnal T60 ventilator (Air Liquide Healthcare) will be used for OHD administration.
|
|
他の：PSV/TP/HFO
PSV follow by T piece follow by HFO
|
The endotracheal tube will be disconnected from the ventilator, and a T-piece (Teleflex, Trach-Vent +®) with oxygen delivery
The endotracheal tube will be connected to the pneumotachograph.
The ventilator settings will be adjusted as follows: VS mode, inspiratory support at 7 cmH₂O, PEEP at 0 cmH₂O.
The endotracheal tube will be disconnected from the ventilator, and an OHD delivery device normally used for tracheostomies (Fisher & Paykel, Optiflow+®) will be connected to the pneumotachograph.
The OHD flow rate will be set to 50 L/min.
A Monnal T60 ventilator (Air Liquide Healthcare) will be used for OHD administration.
|
|
他の：HFO/TP/PSV
HFO follow by T piece follow by PSV
|
The endotracheal tube will be disconnected from the ventilator, and a T-piece (Teleflex, Trach-Vent +®) with oxygen delivery
The endotracheal tube will be connected to the pneumotachograph.
The ventilator settings will be adjusted as follows: VS mode, inspiratory support at 7 cmH₂O, PEEP at 0 cmH₂O.
The endotracheal tube will be disconnected from the ventilator, and an OHD delivery device normally used for tracheostomies (Fisher & Paykel, Optiflow+®) will be connected to the pneumotachograph.
The OHD flow rate will be set to 50 L/min.
A Monnal T60 ventilator (Air Liquide Healthcare) will be used for OHD administration.
|
|
他の：HFO/PSV/TP
HFO follow by PSV follow by TP
|
The endotracheal tube will be disconnected from the ventilator, and a T-piece (Teleflex, Trach-Vent +®) with oxygen delivery
The endotracheal tube will be connected to the pneumotachograph.
The ventilator settings will be adjusted as follows: VS mode, inspiratory support at 7 cmH₂O, PEEP at 0 cmH₂O.
The endotracheal tube will be disconnected from the ventilator, and an OHD delivery device normally used for tracheostomies (Fisher & Paykel, Optiflow+®) will be connected to the pneumotachograph.
The OHD flow rate will be set to 50 L/min.
A Monnal T60 ventilator (Air Liquide Healthcare) will be used for OHD administration.
|
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 |
|---|---|
|
Respiratory work during the weaning test, defined as the energy expended to inhale and exhale a respiratory gas, measured in joules per liter per minute.
時間枠：190 min
|
190 min
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Tidal Volume
時間枠：190 min
|
190 min
|
|
Total Positive End-Expiratory Pressure
時間枠：190 min
|
190 min
|
|
Respiratory Rate
時間枠：190 min
|
190 min
|
|
minute ventilation
時間枠：190 min
|
190 min
|
|
Ratio Respiratory rate/ Tidal volume
時間枠：190 min
|
190 min
|
|
product pressure time
時間枠：190 min
|
190 min
|
|
Occlusion pressure (or P 0.1)
時間枠：190 min
|
190 min
|
|
Percentage of success on the weaning test (predefined criteria)
時間枠：190 min
|
190 min
|
その他の成果指標
結果測定 |
時間枠 |
|---|---|
|
Percentage of patients extubated following the series of weaning trials
時間枠：190 min
|
190 min
|
|
Percentage of reintubations within 48 hours after extubation
時間枠：52 hours
|
52 hours
|
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。
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 (推定)
2027年1月1日
一次修了 (推定)
2027年1月1日
研究の完了 (推定)
2027年1月1日
試験登録日
最初に提出
2026年7月20日
QC基準を満たした最初の提出物
2026年7月20日
最初の投稿 (実際)
2026年7月24日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月24日
QC基準を満たした最後の更新が送信されました
2026年7月20日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- 38RC25.0307
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
米国で製造され、米国から輸出された製品。
いいえ
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。