Protocolized Weaning of High-Flow Nasal Cannula in Adult Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRush University Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients ≥ 18 years
Receiving HFNC for ≥12 hours
Patients using HFNC to avoid intubation
Post-extubated patients who develop acute hypoxemic respiratory failure, regardless of respiratory support device prior to HFNC use.
Disqualifiers
• 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)
Trial design
Design model
Parallel
Treatments tested in this trial
Protocolized HFNC Weaning Strategy
BehavioralA 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 Weaning
BehavioralHigh-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.
Treatment groups
2,000 Participants
are divided into 2 treatment groupsGroup A: Usual Care HFNC WeaningActive comparator 1 intervention
Group B: Protocolized HFNC WeaningExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Up to 5 days after study enrollmentSecondary outcomes
1
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 enrollment2
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 enrollment3
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 enrollment4
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 enrollmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Rush University Medical Center
Lead sponsor
The First Affiliated Hospital of Xiamen University
Collaborator
First Hospital of China Medical University
Collaborator
Shanghai Zhongshan Hospital
Collaborator
Binzhou Medical University
Collaborator
First Affiliated Hospital of Chongqing Medical University
Collaborator
Changhai Hospital
Collaborator
Source ClinicalTrials.gov
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