Effect of High Flow Nasal Therapy (HFNC) Weaning Protocols vs Standard of Care on Respiratory Outcomes in Patients With Acute Respiratory Failure

Официальное название

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

Обзор

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.

Вмешательства

• Другое Protocolized HFNC weaning
  HFNC discontinuation based on ROX index ≥9.2 and FiO₂ ≤40%

Первичные конечные точки

• Weaning failure [Срок оценки: Within 48 hours after the first separation attempt]

Вторичные конечные точки (8)

• Second-attempt weaning success [Срок оценки: Within 48 hours after the second separation attempt]
• Length of hospital stay [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: From enrollment through hospital discharge, an average of 10 days.]
• Number of days of HFNC treatment from initiation to definitive discontinuation [Срок оценки: 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 [Срок оценки: 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. [Срок оценки: 30 minutes before HFNC weaning initiation and 24 hours after weaning completion.]
• Changes in diaphragmatic function [Срок оценки: Before HFNC discontinuation and within 48 hours after weaning attempt]

Критерии участия

Критерии включения

• Age ≥18 years
• Presence of acute respiratory failure (ARF)
• Receiving HFNC treatment for ≥24 hours

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Италия · 2 центра

• Pulmonology Unit, ASST Santi Paolo e Carlo. Department of Health Sciences, University of M — Milan
• Pulmonology Unit, University Hospital "G. Rodolico-San Marco" — Catania

Идентификаторы

NCT: NCT07638293 · THE WHIP TRIAL

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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