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| Name | Class |
|---|---|
| The First Affiliated Hospital of Xiamen University | OTHER |
| First Hospital of China Medical University | OTHER |
| Shanghai Zhongshan Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care HFNC Weaning | Active Comparator | 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. |
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| Protocolized HFNC Weaning | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Protocolized HFNC Weaning Strategy | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients successfully weaned from HFNC on day 5 of 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants successfully weaned from HFNC by Day 1 | 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 |
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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:
The bedside clinical team determines that HFNC weaning is clinically appropriate
Demonstrates clinical stability, defined as:
Exclusion Criteria:
• Planned procedures requiring intubation
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jie Li, PhD | Contact | 13125634643 | Jie_Li@rush.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
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.
Data will be available beginning 6 months after publication of the primary results and will remain available for 5 years thereafter.
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.
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| Binzhou Medical University |
| OTHER |
| First Affiliated Hospital of Chongqing Medical University | OTHER |
| Changhai Hospital | OTHER |
This is a multicenter stepped-wedge cluster randomized trial. Eight hospital clusters will begin in the control phase (usual care) and sequentially transition to the intervention phase (protocolized HFNC weaning) according to a predefined rollout schedule. At each time period, one additional hospital will cross over from control to intervention until all clusters have implemented the protocol. All eligible patients within a cluster will receive the treatment condition assigned to that cluster during each time period.
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| Usual Care HFNC Weaning | Behavioral | 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. |
|
| Proportion of participants successfully weaned from HFNC by Day 2 | 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 | 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 | 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 | 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) | 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 | 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 | 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 | 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 | 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 | 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) | 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 | 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) | Number of days from hospital admission to hospital discharge during the index hospitalization. | During index hospitalization, up to 28 days after enrollment |
| ICU mortality | Proportion of participants who die during the ICU stay. | During ICU stay, up to 28 days after enrollment |
| Hospital mortality | Proportion of participants who die during the index hospitalization. | During hospitalization, up to 28 days after enrollment |
| Adverse events related to HFNC therapy | 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 |