An interventional study of Protocolized HFNC Weaning Strategy and Usual Care HFNC Weaning in Acute Hypoxemic Respiratory Failure and High-Flow Nasal Cannula Therapy, sponsored by Rush University Medical Center. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Rush University Medical Center · Not applicable, Interventional, and Treatment
Among 349 studies in Respiratory Insufficiency with a site in United States — 44 open to participants now, 61 under way, 1 of them phase 3. Respiratory Insufficiency · United States.
Among the 349 studies in Respiratory Insufficiency with a site in United States, this one is the 12th largest by planned enrollment of the 253 interventional ones, is one of 19 that started in 2026, is one of 159 with no phase, reaches primary completion later than 47 of the 60 other live ones, and was the 339th registered.
1,369 studies on the registry are indexed under Respiratory Insufficiency; 264 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 60 across 860 interventional studies indexed under Respiratory Insufficiency.
Browse Respiratory Insufficiency studies →44 of the 349 studies in Respiratory Insufficiency with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 178 Respiratory Insufficiency studies recruiting now, 134 (75%) set no upper age limit and 18 (10%) stop at 75 or younger; 21 take children under 18; 19 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →349 studies; the count open now beside each. This study's row is marked.
First in 1992; this study’s year is marked. 19 started in 2026.
Median enrollment 42 across the 253 interventional studies, 65 across the 95 observational. Of the 245 that completed or were terminated, 93 (38%) have results posted.
47 of 349 have an industry lead sponsor. The 10 most frequent:
Rush University Medical Center is the lead sponsor of 397 studies on the registry; 61 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 26 (81%) have results posted.
Rush University Medical Center has 6 studies filed under Respiratory Insufficiency — fewer than ten, so there is no comparison to draw.
25 of the studies in Respiratory Insufficiency with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04360538University of ChicagoLong Term Outcomes of Patients With COVID-19 | 2026-11-01 |
| NCT07217197Thomas Jefferson UniversityRespiratory Monitoring System That Detects & Predicts OIRD | 2026-11-30 |
| NCT04664192Baylor Research InstituteBio-Banking of Specimens for Advanced Lung Disease and Lung Transplant Research | 2026-12-01 |
| NCT05462600University of California, San DiegoDistribution of Ventilation, Respiratory Drive and Gas Exchange: Measurements and Monitoring | 2026-12-30 |
| NCT05893420AgileMD, Inc.A Rapid Diagnostic of Risk in Hospitalized Patients Using Machine Learning | 2026-12-31 |
Among the 349 studies in Respiratory Insufficiency with a site in United States, from their registry updates:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Demonstrates clinical stability, defined as:
Exclusion Criteria:
Planned procedures requiring intubation
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.
Behavioral: Usual Care HFNC Weaning
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.
Behavioral: Protocolized HFNC Weaning Strategy
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.
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 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.
Time frame: Up to 5 days after study enrollment
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: During index hospitalization, up to 28 days after enrollment
ICU mortality
Proportion of participants who die during the ICU stay.
Time frame: During ICU stay, up to 28 days after enrollment
Hospital mortality
Proportion of participants who die during the index hospitalization.
Time frame: 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.
Time frame: During hospitalization, up to 28 days after enrollment
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: Data will be available beginning 6 months after publication of the primary results and will remain available for 5 years thereafter.
Access criteria: 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.
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Apr 2028, 17 months later.
Of 359 non-industry interventional studies with no phase under Respiratory Insufficiency, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 47. This study's planned 17 months is below that.
Counting every sponsor, half of 375 studies reached it within 24 months; a quarter within 10 and three quarters within 46.
Since we started tracking on Sep 25, 2026, the dates moved once, on Sep 25, 2026: start Sep 2026 → Nov 2026 and primary completion Mar 2028 → Apr 2028.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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