Acute Hypoxemic Respiratory FailurePRO-WEAN HFNCNCT07452406
Protocolized Weaning of High-Flow Nasal Cannula in Adult Patients
A study testing Protocolized HFNC Weaning Strategy in people with Acute Hypoxemic Respiratory Failure and High-Flow Nasal Cannula Therapy, run by Rush University Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Hypoxemic Respiratory Failure, High-Flow Nasal Cannula Therapy
- What is being tested?
- Protocolized HFNC Weaning Strategy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 28 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- • 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official title: Protocolized Weaning of High-Flow Nasal Cannula in Adult Patients: A Stepped-Wedge Cluster Randomized Trial (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.
Read more
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.
Read the detailed description
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.
- Being tested
- Protocolized HFNC Weaning Strategy, Usual Care HFNC Weaning
- Keywords
- High-flow nasal cannula, Acute hypoxemic respiratory failure, Weaning
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protocolized HFNC Weaning StrategyBehavioural
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.
Usual Care HFNC WeaningBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Usual Care HFNC Weaning |
| 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. Receives: Behavioral: Protocolized HFNC Weaning Strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 5 days after study enrollment
Secondary outcomes (17)
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.
Measured: Up to 1 day after study enrollment
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: During index hospitalization, up to 28 days after enrollment
ICU mortality
Proportion of participants who die during the ICU stay.
Measured: During ICU stay, up to 28 days after enrollment
Hospital mortality
Proportion of participants who die during the index hospitalization.
Measured: 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.
Measured: During hospitalization, up to 28 days after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start1 Nov 2026 (estimated)
- Primary completion30 Apr 2028 (estimated)
- Study completion28 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Hypoxemic Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Xiamen University, First Hospital of China Medical University, Shanghai Zhongshan Hospital, Binzhou Medical University, First Affiliated Hospital of Chongqing Medical University, Changhai Hospital
- Responsible party
- Principal investigator, Jie Li, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07452406
- Sponsor's protocol ID
- HFNC weaning
- Acronym
- PRO-WEAN HFNC
- Status last verified
- Sep 2026
- First submitted
- 28 Feb 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocolized Weaning of High-Flow Nasal Cannula in Adult Patients: A Stepped-Wedge Cluster Randomized Trial (PRO-WEAN HFNC)
- ClinicalTrials.gov ID
- NCT07452406
- Acronym / sponsor ID
- PRO-WEAN HFNC / HFNC weaning
- Keywords
- High-flow nasal cannula, Acute hypoxemic respiratory failure, Weaning
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Xiamen University, First Hospital of China Medical University, Shanghai Zhongshan Hospital, Binzhou Medical University, First Affiliated Hospital of Chongqing Medical University, Changhai Hospital
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 28 Jun 2028 (estimated)
- First posted
- 5 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Usual Care HFNC Weaning | Active comparator | Behavioral: Usual Care HFNC WeaningDuring 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. |
| Protocolized HFNC Weaning | Experimental | Behavioral: Protocolized HFNC Weaning StrategyParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (6 listed)
- • Planned procedures requiring intubation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protocolized HFNC Weaning StrategyA 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. | Behavioural | Protocolized HFNC Weaning |
| Usual Care HFNC WeaningHigh-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. | Behavioural | Usual Care HFNC Weaning |
Primary outcome
Proportion of patients successfully weaned from HFNC on day 5 of study enrollment
Time frame: 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.
17 secondary outcomes
Proportion of participants successfully weaned from HFNC by Day 1
Time frame: Up to 1 day after study enrollment
Proportion of participants successfully weaned from HFNC by Day 2
Time frame: Up to 2 days after study enrollment
Proportion of participants successfully weaned from HFNC by Day 3
Time frame: Up to 3 days after study enrollment
Proportion of participants successfully weaned from HFNC by Day 4
Time frame: Up to 4 days after study enrollment
Proportion of participants successfully weaned from HFNC by Day 7
Time frame: Up to 7 days after study enrollment
HFNC duration (hours)
Time frame: From HFNC initiation until hospital discharge, up to 28 days
Oxygen-free days through Day 28
Time frame: Up to 28 days after study enrollment
HFNC Weaning Duration
Time frame: From study enrollment until HFNC discontinuation, up to 28 days
Proportion of participants requiring noninvasive ventilation within 48 hours after HFNC discontinuation
Time frame: Within 48 hours after HFNC discontinuation
Proportion of participants requiring re-initiation of HFNC within 48 hours after discontinuation
Time frame: Within 48 hours after HFNC discontinuation
Proportion of participants requiring invasive mechanical ventilation within 48 hours after HFNC discontinuation
Time frame: Within 48 hours after HFNC discontinuation
Duration of invasive mechanical ventilation (hours)
Time frame: During hospitalization, up to 28 days after enrollment
ICU Length of Stay
Time frame: During index hospitalization, up to 28 days after enrollment
Hospital length of stay (days)
Time frame: During index hospitalization, up to 28 days after enrollment
ICU mortality
Time frame: During ICU stay, up to 28 days after enrollment
Hospital mortality
Time frame: During hospitalization, up to 28 days after enrollment
Adverse events related to HFNC therapy
Time frame: During hospitalization, up to 28 days after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Acute Hypoxemic Respiratory Failure
Recruiting
Spontaneous vs Controlled Mechanical Ventilation in Acute Hypoxemic Respiratory Failure
Acute Respiratory Distress Syndrome (ARDS), Acute Hypoxemic Respiratory Failure
RecruitingPhase 2
Interleukin-6 Guided Treatment With Dexamethasone or Tocilizumab in Patients Hospitalized With Acute Respiratory Symptoms - a Feasibility Study
Acute Hypoxemic Respiratory Failure
Recruiting
Physiological Effects of Continuous Negative External Pressure for Acute Hypoxemic Respiratory Failure
Acute Hypoxemic Respiratory Failure
Active, not recruiting
Optimizing Care in Critically Ill at UCHealth by Liberalizing the Target O2 in Mechanically-ventilated ICU Patients
Respiratory Failure, Acute Hypoxemic Respiratory Failure
RecruitingObservational study
EndotyPIng PreHospitAl de Novo Acute hYpoxemic Respiratory Failure
Acute Hypoxemic Respiratory Failure, Acute Respiratory Distress Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protocolized HFNC Weaning Strategy in people with Acute Hypoxemic Respiratory Failure and High-Flow Nasal Cannula Therapy, run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jie Li, PhD (13125634643, Jie_Li@rush.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients successfully weaned from HFNC on day 5 of study enrollment (time frame: Up to 5 days after study enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.