Effect of High Flow Nasal Therapy (HFNC) Weaning Protocols vs Standard of Care on Respiratory Outcomes in Patients With Acute Respiratory Failure (WHIP)
2026年6月4日 更新者：Michele Mondoni、University of Milan
Effect of High Flow Nasal Therapy (HFNC) Weaning Protocols vs Standard of Care on Respiratory Outcomes in Patients With Acute Respiratory Failure: A Randomized Clinical Trial
High-flow nasal cannula (HFNC) is a widely used noninvasive respiratory support technique for patients with acute respiratory failure (ARF).
It provides heated and humidified oxygen at high flow rates, improving oxygenation, reducing respiratory effort, and enhancing patient comfort.
International guidelines recommend HFNC over conventional oxygen therapy in hypoxemic ARF.
However, there is significant variability in clinical practice regarding HFNC discontinuation, and no standardized weaning criteria currently exist.
Prolonged HFNC use may increase hospital stay and healthcare costs, while premature discontinuation may lead to respiratory deterioration and the need for further ventilatory support.
Previous studies suggest that successful HFNC weaning may be predicted by a Fraction of inspired oxygen (FiO₂) ≤40% and a Respiratory rate-Oxygenation index (ROX index) ≥9.2.
The ROX index is calculated as the ratio of peripheral oxygen saturation (SpO₂) divided by fraction of inspired oxygen (FiO₂) to respiratory rate.
The primary objective of this study is to compare a standardized HFNC weaning strategy based on ROX index and FiO₂ thresholds with usual clinical practice based on physician judgment.
The primary outcome is weaning failure at the first attempt, defined as the need for HFNC reinstitution, noninvasive or invasive mechanical ventilation, or death within 48 hours after discontinuation.
調査の概要
研究の種類
介入
入学 (推定)
148
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。
研究連絡先
- 名前：Michele Mondoni, MD
- 電話番号：+39 0240223025
- メール：michele.mondoni@unimi.it
研究場所
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Lombardy
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Milan、Lombardy、イタリア、20142
- 募集
- Pulmonology Unit, ASST Santi Paolo e Carlo. Department of Health Sciences, University of Milan, Milan (Italy)
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Sicily
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Catania、Sicily、イタリア、95123
- まだ募集していません
- Pulmonology Unit, University Hospital "G. Rodolico-San Marco"
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コンタクト：
- Claudia Crimi, MD PhD
- 電話番号：+39 095 3781352
- メール：claudia.crimi@unict.it
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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
- 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:
- Age ≥18 years
- Presence of acute respiratory failure (ARF)
- Receiving HFNC treatment for ≥24 hours
Exclusion Criteria:
- Post-extubation HFNC use or tracheostomized patients
- Respiratory acidosis (pH <7.35) or clinically significant acute hypercapnia (pCO₂ >50 mmHg with worsening from baseline)
- Long-term home NIV or home CPAP use
- Do-not-intubate (DNI) orders precluding escalation to invasive mechanical ventilation
- Life expectancy ≤48-72 hours due to terminal non-respiratory disease
- Neurological impairment or deep sedation preventing safe HFNC use (e.g. coma or severe uncontrolled delirium)
- Technical contraindications to HFNC (i.e. facial trauma, maxillofacial surgery, severe nasal obstruction)
- Refusal to participate or inability to provide informed consent
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：他の
- 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：Non-protocolized weaning
Non-protocolized weaning according to standard clinical practice: HFNC assessment every 24 hours and discontinuation based on physician clinical judgment.
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実験的：Protocolized weaning
Protocolized weaning using ROX index + FiO₂
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HFNC discontinuation based on ROX index ≥9.2 and FiO₂ ≤40%
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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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Weaning failure
時間枠：Within 48 hours after the first separation attempt
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To compare the percentage of patients who fail HFNC weaning within 48 hours after the first separation attempt using a protocolized HFNC weaning strategy based on ROX index and FiO₂ cut-offs versus standard clinical practice guided by physician judgment.
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Within 48 hours after the first separation attempt
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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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Second-attempt weaning success
時間枠：Within 48 hours after the second separation attempt
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To compare the percentage of patients who fail HFNC weaning within 48 hours after the second separation attempt using a protocolized HFNC weaning strategy based on ROX index and FiO₂ cut-offs versus standard clinical practice guided by physician judgment.
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Within 48 hours after the second separation attempt
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Length of hospital stay
時間枠：From the day of hospital admission until the day of hospital discharge, assessed up to 60 days; and from the day of HFNC discontinuation until the day of hospital discharge, assessed up to 60 days.
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Comparison of total hospital stay and post-weaning hospital stay between the two study arms.
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From the day of hospital admission until the day of hospital discharge, assessed up to 60 days; and from the day of HFNC discontinuation until the day of hospital discharge, assessed up to 60 days.
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In-hospital and 30-day mortality
時間枠：From the day of admission to the day of discharge or death (in-hospital mortality) and from the day of admission to 30-day after discharge (30-day mortality)
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Comparison of in-hospital mortality and 30-day mortality after discharge between the two study arms.
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From the day of admission to the day of discharge or death (in-hospital mortality) and from the day of admission to 30-day after discharge (30-day mortality)
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Predictors of weaning success
時間枠：From enrollment through hospital discharge, an average of 10 days.
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Identification of clinical and respiratory variables associated with successful HFNC weaning.
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From enrollment through hospital discharge, an average of 10 days.
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Number of days of HFNC treatment from initiation to definitive discontinuation
時間枠：From the date and time of HFNC initiation until the date and time of definitive HFNC discontinuation, assessed up to 30 days.
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Number of days of HFNC treatment from initiation to definitive discontinuation
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From the date and time of HFNC initiation until the date and time of definitive HFNC discontinuation, assessed up to 30 days.
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Predictors of HFNC treatment duration
時間枠：From HFNC initiation through hospital discharge, an average of 10 days
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Demographic, clinical, radiological and laboratory variables associated with HFNC treatment duration
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From HFNC initiation through hospital discharge, an average of 10 days
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Prevalence of diaphragmatic dysfunction assessed by diaphragm thickening fraction (DTF) and diaphragmatic excursion measured by ultrasound between the two study arms.
時間枠：30 minutes before HFNC weaning initiation and 24 hours after weaning completion.
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Comparison of the prevalence of diaphragmatic dysfunction assessed by diaphragmatic ultrasound between patients with successful HFNC weaning and those with weaning failure.
Diaphragmatic function will be evaluated using diaphragm thickening fraction (DTF) and diaphragmatic excursion measured by ultrasound.
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30 minutes before HFNC weaning initiation and 24 hours after weaning completion.
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Changes in diaphragmatic function
時間枠：Before HFNC discontinuation and within 48 hours after weaning attempt
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Evaluation of diaphragmatic ultrasound parameters before and after HFNC discontinuation.
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Before HFNC discontinuation and within 48 hours after weaning attempt
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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
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)
2026年5月15日
一次修了 (推定)
2028年5月1日
研究の完了 (推定)
2028年5月1日
試験登録日
最初に提出
2026年5月13日
QC基準を満たした最初の提出物
2026年6月4日
最初の投稿 (実際)
2026年6月10日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月10日
QC基準を満たした最後の更新が送信されました
2026年6月4日
最終確認日
2026年5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。
Protocolized HFNC weaningの臨床試験
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Victor WangNational Institute of Nursing Research (NINR); Pace University完了
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Poitiers University Hospital完了
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Lahore General Hospitalわからない
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The First Affiliated Hospital of Guangzhou Medical...わからない
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Poitiers University Hospital完了
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Southeast University, ChinaThe Second Hospital of Nanjing Medical University; Second Affiliated Hospital of Suzhou University と他の協力者わからない