Effect of High Flow Nasal Therapy (HFNC) Weaning Protocols vs Standard of Care on Respiratory Outcomes in Patients With Acute Respiratory Failure (WHIP)
2026년 6월 4일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (추정된)
148
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Michele Mondoni, MD
- 전화번호: +39 0240223025
- 이메일: michele.mondoni@unimi.it
연구 장소
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Lombardy
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Milan, Lombardy, 이탈리아, 20142
- 모병
- 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, 이탈리아, 95123
- 아직 모집하지 않음
- Pulmonology Unit, University Hospital "G. Rodolico-San Marco"
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연락하다:
- Claudia Crimi, MD PhD
- 전화번호: +39 095 3781352
- 이메일: claudia.crimi@unict.it
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: 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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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Weaning failure
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Second-attempt weaning success
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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.
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 5월 15일
기본 완료 (추정된)
2028년 5월 1일
연구 완료 (추정된)
2028년 5월 1일
연구 등록 날짜
최초 제출
2026년 5월 13일
QC 기준을 충족하는 최초 제출
2026년 6월 4일
처음 게시됨 (실제)
2026년 6월 10일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 10일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 4일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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