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.
研究概览
研究类型
介入性
注册 (估计的)
148
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Michele Mondoni, MD
- 电话号码：+39 0240223025
- 邮箱：michele.mondoni@unimi.it
学习地点
-
-
Lombardy
-
Milan、Lombardy、意大利、20142
- 招聘中
- Pulmonology Unit, ASST Santi Paolo e Carlo. Department of Health Sciences, University of Milan, Milan (Italy)
-
-
Sicily
-
Catania、Sicily、意大利、95123
- 尚未招聘
- Pulmonology Unit, University Hospital "G. Rodolico-San Marco"
-
接触：
- Claudia Crimi, MD PhD
- 电话号码：+39 095 3781352
- 邮箱：claudia.crimi@unict.it
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预：Non-protocolized weaning
Non-protocolized weaning according to standard clinical practice: HFNC assessment every 24 hours and discontinuation based on physician clinical judgment.
|
|
|
实验性的：Protocolized weaning
Protocolized weaning using ROX index + FiO₂
|
HFNC discontinuation based on ROX index ≥9.2 and FiO₂ ≤40%
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Weaning failure
大体时间：Within 48 hours after the first separation attempt
|
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.
|
Within 48 hours after the first separation attempt
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Second-attempt weaning success
大体时间：Within 48 hours after the second separation attempt
|
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.
|
Within 48 hours after the second separation attempt
|
|
Length of hospital stay
大体时间：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.
|
Comparison of total hospital stay and post-weaning hospital stay between the two study arms.
|
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.
|
|
In-hospital and 30-day mortality
大体时间：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)
|
Comparison of in-hospital mortality and 30-day mortality after discharge between the two study arms.
|
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)
|
|
Predictors of weaning success
大体时间：From enrollment through hospital discharge, an average of 10 days.
|
Identification of clinical and respiratory variables associated with successful HFNC weaning.
|
From enrollment through hospital discharge, an average of 10 days.
|
|
Number of days of HFNC treatment from initiation to definitive discontinuation
大体时间：From the date and time of HFNC initiation until the date and time of definitive HFNC discontinuation, assessed up to 30 days.
|
Number of days of HFNC treatment from initiation to definitive discontinuation
|
From the date and time of HFNC initiation until the date and time of definitive HFNC discontinuation, assessed up to 30 days.
|
|
Predictors of HFNC treatment duration
大体时间：From HFNC initiation through hospital discharge, an average of 10 days
|
Demographic, clinical, radiological and laboratory variables associated with HFNC treatment duration
|
From HFNC initiation through hospital discharge, an average of 10 days
|
|
Prevalence of diaphragmatic dysfunction assessed by diaphragm thickening fraction (DTF) and diaphragmatic excursion measured by ultrasound between the two study arms.
大体时间：30 minutes before HFNC weaning initiation and 24 hours after weaning completion.
|
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.
|
30 minutes before HFNC weaning initiation and 24 hours after weaning completion.
|
|
Changes in diaphragmatic function
大体时间：Before HFNC discontinuation and within 48 hours after weaning attempt
|
Evaluation of diaphragmatic ultrasound parameters before and after HFNC discontinuation.
|
Before HFNC discontinuation and within 48 hours after weaning attempt
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年5月15日
初级完成 (估计的)
2028年5月1日
研究完成 (估计的)
2028年5月1日
研究注册日期
首次提交
2026年5月13日
首先提交符合 QC 标准的
2026年6月4日
首次发布 (实际的)
2026年6月10日
研究记录更新
最后更新发布 (实际的)
2026年6月10日
上次提交的符合 QC 标准的更新
2026年6月4日
最后验证
2026年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.