成人患者における高流量鼻カニューレのプロトコル化された離脱：ステップウェッジクラスター無作為化試験 (PRO-WEAN HFNC)
成人患者における高流量鼻カニューレのプロトコル化された離脱：ステップウェッジクラスター無作為化試験（PRO-WEAN HFNC）
High-flow nasal cannula (HFNC) is a type of oxygen therapy commonly used in adults with breathing problems. While HFNC can help patients avoid breathing tubes and improve oxygen levels, there is no standard method for deciding how and when to reduce and stop this therapy once a patient improves. In many hospitals, these decisions vary from clinician to clinician.
This study will compare usual care with a standardized step-by-step plan for reducing HFNC support. Eight hospitals will participate and will switch from usual care to the standardized plan at different time points during the study.
The main goal is to determine whether the standardized weaning plan increases the number of patients who can successfully stop HFNC within 5 days. The study will also evaluate how long patients remain on HFNC, whether they need additional breathing support, and how long they stay in the hospital.
The results may help develop clearer guidance for safely and efficiently stopping HFNC therapy.
調査の概要
状態
詳細な説明
High-flow nasal cannula (HFNC) therapy has become a standard treatment for acute hypoxemic respiratory failure. Although evidence supports its use for improving oxygenation and reducing intubation risk, guidance on how to discontinue HFNC remains limited. Current weaning practices are highly variable across institutions and clinicians. This variability may contribute to either premature discontinuation, leading to respiratory deterioration, or prolonged therapy, which may delay ICU discharge and increase healthcare utilization.
This trial evaluates implementation of a standardized HFNC weaning protocol across multiple hospitals using a stepped-wedge cluster randomized design. The intervention focuses on structured, progressive reduction of HFNC flow and fraction of inspired oxygen (FiO₂), with predefined criteria for discontinuation and re-escalation of support.
The stepped-wedge approach allows sequential implementation of the protocol across participating hospitals while accounting for secular trends and inter-site practice variability. The study is designed to determine whether protocolized weaning improves efficiency and clinical outcomes compared with usual care.
Findings from this trial are intended to inform evidence-based guidance for HFNC liberation strategies in adult patients with acute hypoxemic respiratory failure.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Jie Li, PhD
- 電話番号：13125634643
- メール：Jie_Li@rush.edu
研究場所
-
-
Illinois
-
Chicago、Illinois、アメリカ、60612
- Rush University Medical Center
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
-
Adult patients ≥ 18 years
-
Receiving HFNC for ≥12 hours
-
Receiving HFNC to treat acute hypoxemic respiratory failure, defined as requirement of FIO2 ≥ 0.5 to maintain SpO2 at 90-97% and Evidence of increased work of breathing at initiation (e.g., tachypnea with respiratory rate > 20-25/min, or accessory muscle use), including:
- Patients using HFNC to avoid intubation
- Post-extubated patients who develop acute hypoxemic respiratory failure, regardless of respiratory support device prior to HFNC use.
-
The bedside clinical team determines that HFNC weaning is clinically appropriate
-
Demonstrates clinical stability, defined as:
- Respiratory rate ≤ 25 breaths per minute without use of accessory respiratory muscles
- SpO₂ > 90% on HFNC
- HFNC FiO₂ ≤ 0.80
Exclusion Criteria:
-
• Planned procedures requiring intubation
- Hypercapnia (PaCO2 ≥ 45 mmHg)
- Receiving extracorporeal membrane oxygenation (ECMO)
- Receiving continuous aerosol therapy via HFNC (e.g., inhaled nitric oxide [iNO], epoprostenol, or continuous albuterol)
- Receiving chronic home use of HFNC, CPAP, or noninvasive ventilation therapy to treat chronic respiratory failure
- Receiving HFNC as preventative post-extubation therapy, defined as HFNC use immediately after extubation for less than 48 hr in the absence of clinical signs of respiratory failure.
研究計画
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：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 |
|---|---|
|
アクティブコンパレータ：Usual Care HFNC Weaning
During this phase, high-flow nasal cannula (HFNC) weaning and discontinuation are performed according to local standard practice without a mandated protocol. Decisions regarding reduction of flow and fraction of inspired oxygen (FiO₂), transition to conventional oxygen therapy, and re-escalation of support are made at the discretion of the treating clinical team. |
High-flow nasal cannula (HFNC) weaning and discontinuation are performed according to local standard clinical practice without a mandated protocol. Decisions regarding reduction of flow and fraction of inspired oxygen (FiO₂), transition to conventional oxygen therapy, and escalation of respiratory support are made at the discretion of the treating clinical team. |
|
実験的：Protocolized HFNC Weaning
Participants receive a standardized HFNC weaning protocol consisting of structured, stepwise reduction of flow and FiO₂ with predefined criteria for discontinuation and criteria for treatment failure requiring re-escalation of respiratory support. The protocol is implemented at the hospital level during the intervention phase of the stepped-wedge design. |
A standardized high-flow nasal cannula (HFNC) weaning protocol consisting of structured, stepwise reduction of flow and fraction of inspired oxygen (FiO₂) with predefined criteria for discontinuation and predefined criteria for treatment failure requiring re-escalation of respiratory support. The protocol is implemented at the hospital level during the intervention phase of the stepped-wedge cluster randomized design. |
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 |
|---|---|---|
|
Proportion of patients successfully weaned from HFNC on day 5 of study enrollment
時間枠：Up to 5 days after study enrollment
|
HFNC weaning success is defined as discontinuation of high-flow nasal cannula therapy with the participant alive and breathing on conventional oxygen therapy or room air without need for noninvasive ventilation, CPAP, invasive mechanical ventilation, or re-initiation of HFNC within 24 hours of discontinuation. Participants remaining on HFNC beyond Day 5 are considered weaning failures. |
Up to 5 days after study enrollment
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Proportion of participants successfully weaned from HFNC by Day 1
時間枠：Up to 1 day after study enrollment
|
HFNC weaning success is defined as discontinuation of high-flow nasal cannula therapy with the participant alive and without need for noninvasive ventilation, CPAP, invasive mechanical ventilation, or re-initiation of HFNC within 24 hours of discontinuation. |
Up to 1 day after study enrollment
|
|
Proportion of participants successfully weaned from HFNC by Day 2
時間枠：Up to 2 days after study enrollment
|
HFNC weaning success is defined as discontinuation of high-flow nasal cannula therapy with the participant alive and without need for noninvasive ventilation, CPAP, invasive mechanical ventilation, or re-initiation of HFNC within 24 hours of discontinuation. |
Up to 2 days after study enrollment
|
|
Proportion of participants successfully weaned from HFNC by Day 3
時間枠：Up to 3 days after study enrollment
|
HFNC weaning success is defined as discontinuation of high-flow nasal cannula therapy with the participant alive and without need for noninvasive ventilation, CPAP, invasive mechanical ventilation, or re-initiation of HFNC within 24 hours of discontinuation. |
Up to 3 days after study enrollment
|
|
Proportion of participants successfully weaned from HFNC by Day 4
時間枠：Up to 4 days after study enrollment
|
HFNC weaning success is defined as discontinuation of high-flow nasal cannula therapy with the participant alive and without need for noninvasive ventilation, CPAP, invasive mechanical ventilation, or re-initiation of HFNC within 24 hours of discontinuation. |
Up to 4 days after study enrollment
|
|
Proportion of participants successfully weaned from HFNC by Day 7
時間枠：Up to 7 days after study enrollment
|
HFNC weaning success is defined as discontinuation of high-flow nasal cannula therapy with the participant alive and without need for noninvasive ventilation, CPAP, invasive mechanical ventilation, or re-initiation of HFNC within 24 hours of discontinuation. |
Up to 7 days after study enrollment
|
|
HFNC duration (hours)
時間枠：From HFNC initiation until hospital discharge, up to 28 days
|
Total duration of high-flow nasal cannula (HFNC) therapy measured in hours from initiation of HFNC until permanent discontinuation of HFNC during the hospitalization. |
From HFNC initiation until hospital discharge, up to 28 days
|
|
Oxygen-free days through Day 28
時間枠：Up to 28 days after study enrollment
|
Number of days alive and not receiving any supplemental oxygen (including HFNC, conventional oxygen therapy, noninvasive ventilation, or invasive mechanical ventilation) during the first 28 days after study enrollment. Participants who die before Day 28 will be assigned zero oxygen-free days. |
Up to 28 days after study enrollment
|
|
HFNC Weaning Duration
時間枠：From study enrollment until HFNC discontinuation, up to 28 days
|
Duration in hours from study enrollment to permanent discontinuation of high-flow nasal cannula therapy among participants who meet criteria for weaning success. |
From study enrollment until HFNC discontinuation, up to 28 days
|
|
Proportion of participants requiring noninvasive ventilation within 48 hours after HFNC discontinuation
時間枠：Within 48 hours after HFNC discontinuation
|
Proportion of participants who require initiation of noninvasive ventilation (e.g., BiPAP or CPAP for respiratory failure) within 48 hours after HFNC discontinuation. |
Within 48 hours after HFNC discontinuation
|
|
Proportion of participants requiring re-initiation of HFNC within 48 hours after discontinuation
時間枠：Within 48 hours after HFNC discontinuation
|
Proportion of participants who require re-initiation of high-flow nasal cannula therapy within 48 hours after initial discontinuation. |
Within 48 hours after HFNC discontinuation
|
|
Proportion of participants requiring invasive mechanical ventilation within 48 hours after HFNC discontinuation
時間枠：Within 48 hours after HFNC discontinuation
|
Proportion of participants who require endotracheal intubation and invasive mechanical ventilation within 48 hours after HFNC discontinuation. |
Within 48 hours after HFNC discontinuation
|
|
Duration of invasive mechanical ventilation (hours)
時間枠：During hospitalization, up to 28 days after enrollment
|
Total duration of invasive mechanical ventilation measured in hours from initiation of endotracheal intubation until successful extubation during hospitalization. |
During hospitalization, up to 28 days after enrollment
|
|
ICU Length of Stay
時間枠：During index hospitalization, up to 28 days after enrollment
|
Number of days from ICU admission to ICU discharge during the index hospitalization |
During index hospitalization, up to 28 days after enrollment
|
|
Hospital length of stay (days)
時間枠：During index hospitalization, up to 28 days after enrollment
|
Number of days from hospital admission to hospital discharge during the index hospitalization. |
During index hospitalization, up to 28 days after enrollment
|
|
ICU mortality
時間枠：During ICU stay, up to 28 days after enrollment
|
Proportion of participants who die during the ICU stay. |
During ICU stay, up to 28 days after enrollment
|
|
Hospital mortality
時間枠：During hospitalization, up to 28 days after enrollment
|
Proportion of participants who die during the index hospitalization. |
During hospitalization, up to 28 days after enrollment
|
|
Adverse events related to HFNC therapy
時間枠：During hospitalization, up to 28 days after enrollment
|
Incidence of adverse events during HFNC therapy, including but not limited to skin breakdown, nasal or facial injury, epistaxis, or other clinically significant complications documented during hospitalization. |
During hospitalization, up to 28 days after enrollment
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
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?
IPD プランの説明
De-identified individual participant data underlying the results reported in the publication (including data dictionaries) will be made available to qualified researchers upon reasonable request and with appropriate institutional ethics approval after publication of the primary results. Requests must include a methodologically sound research proposal and will require approval by the study investigators and participating institutions. Data will be shared under a data use agreement to ensure participant confidentiality and compliance with institutional and regulatory policies.
IPD 共有時間枠
Data will be available beginning 6 months after publication of the primary results and will remain available for 5 years thereafter.
IPD 共有アクセス基準
Access to de-identified individual participant data, data dictionaries, statistical analysis plan, and analytic code will be granted to qualified researchers who submit a methodologically sound research proposal. Requests must receive approval from the study investigators and participating institutions and obtain appropriate institutional ethics approval. Data will be shared under a data use agreement to ensure participant confidentiality and compliance with institutional and regulatory requirements.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
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