Protocolized Weaning of High-Flow Nasal Cannula in Adult Patients

NCT07452406 | Not Yet Recruiting DMC

• 1 other identifier: HFNC weaning
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Acute Hypoxemic Respiratory Failure; High-Flow Nasal Cannula Therapy

Keywords

High-flow nasal cannula; Acute hypoxemic respiratory failure; Weaning

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (17)

• Proportion of participants successfully weaned from HFNC by Day 1

  Up to 1 day after study enrollment

• Proportion of participants successfully weaned from HFNC by Day 2

  Up to 2 days after study enrollment

• Proportion of participants successfully weaned from HFNC by Day 3

  Up to 3 days after study enrollment

• Proportion of participants successfully weaned from HFNC by Day 4

  Up to 4 days after study enrollment

• Proportion of participants successfully weaned from HFNC by Day 7

  Up to 7 days after study enrollment

Study Arms (2)

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.

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.

Behavioral: Protocolized HFNC Weaning Strategy

Interventions

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.

Protocolized HFNC Weaning

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.

Usual Care HFNC Weaning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: collaborator
• Sir Run Run Shaw Hospital: collaborator
• Binzhou Medical University: collaborator
• First Affiliated Hospital of Chongqing Medical University: collaborator
• Changhai Hospital: collaborator
• Rush University Medical Center: lead
• The First Affiliated Hospital of Xiamen University: collaborator
• First Hospital of China Medical University: collaborator

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Central Study Contacts

Jie Li, PhD

CONTACT

13125634643; Jie_Li@rush.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 28, 2026
• First Posted: March 5, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): April 28, 2027
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.

Locations

US (1)