Weaning Strategy for Respiratory Impairment
(PRO-WEAN HFNC Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine the best method to reduce and stop high-flow nasal cannula (HFNC) therapy in adults with breathing problems. HFNC improves oxygen levels without a breathing tube, but no standard exists for deciding when to stop it. The study will compare the usual care approach with a new, step-by-step plan (Protocolized HFNC Weaning Strategy) to see if more participants can stop using HFNC within five days. This trial suits adults who have used HFNC for at least 12 hours to treat sudden breathing issues and are stable enough to begin reducing their HFNC use. The results may help establish better guidelines for safely ending HFNC therapy. As an unphased trial, this study allows patients to contribute to developing new HFNC therapy guidelines.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this weaning strategy is safe for patients with respiratory impairment?
Previous studies have shown promising safety results for patients using a standard method to reduce high-flow nasal cannula (HFNC) use. Research indicates that about 90% of patients can successfully stop using HFNC with this method, suggesting it is well-tolerated. Additionally, evidence shows that using HFNC as a step-down treatment from more intense breathing support is generally safe.
Another study found that patients using HFNC had shorter hospital stays, suggesting they recover well without extra complications. While some studies focused on infants or specific conditions, they also reported no major safety concerns with HFNC weaning methods. Overall, the data suggests that the standard approach to reducing HFNC use is safe for patients with breathing problems.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores how a standardized approach to weaning patients off high-flow nasal cannula (HFNC) support could improve outcomes for those with respiratory impairment. Typically, weaning from HFNC is done based on local practices and the discretion of clinical teams, which can vary widely. This trial's protocolized weaning strategy introduces a structured, step-by-step reduction in support, potentially leading to more consistent and possibly faster recovery times. By comparing this method to the usual care approach, researchers hope to find out if a protocolized strategy can provide a more effective transition for patients needing respiratory support.
What evidence suggests that this protocolized HFNC weaning strategy is effective for respiratory impairment?
This trial will compare two strategies for weaning patients from high-flow nasal cannula (HFNC) therapy: a Protocolized HFNC Weaning Strategy and Usual Care HFNC Weaning. Research has shown that a clear plan to reduce HFNC therapy can be effective. Specifically, one study found that following a set protocol reduced the average HFNC usage time from 44 hours to 36.3 hours. Another study reported high success rates in stopping HFNC, with some groups achieving rates as high as 94.7%. A structured plan also enabled patients to leave the hospital sooner. These findings suggest that a well-organized plan can help patients stop HFNC therapy more quickly and safely.12678
Are You a Good Fit for This Trial?
This trial is for adults (18+) with breathing problems who have been on high-flow nasal cannula oxygen therapy for at least 12 hours and are stable enough to start reducing their oxygen support. Patients must be able to keep their blood oxygen above 90% and breathe comfortably without extra effort.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Usual Care HFNC Weaning
High-flow nasal cannula (HFNC) weaning and discontinuation are performed according to local standard practice without a mandated protocol.
Protocolized HFNC Weaning
Participants receive a standardized HFNC weaning protocol consisting of structured, stepwise reduction of flow and FiO₂ with predefined criteria for discontinuation.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including oxygen-free days and adverse events.
What Are the Treatments Tested in This Trial?
Interventions
- Protocolized HFNC Weaning Strategy
- Usual Care HFNC Weaning
Trial Overview
The study compares two ways of reducing high-flow nasal cannula (HFNC) oxygen: a standardized step-by-step weaning plan versus the usual care decided by each clinician. Hospitals will switch between these approaches during the study.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
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
Sir Run Run Shaw Hospital
Collaborator
Binzhou Medical University
Collaborator
First Affiliated Hospital of Chongqing Medical University
Collaborator
Changhai Hospital
Collaborator
Citations
Protocol-Driven Initiation and Weaning of High Flow Nasal ...
The secondary outcome metric, average HFNC treatment hours per patient, decreased from 44.0 to 36.3 hours. Primary and secondary outcomes met criteria for ...
Comparison of three high-flow nasal cannula weaning ...
Results: The weaning success rates in each group were 90.3%, 80.8%, and 76.7% in the FR, OR, and SR group, respectively (p = 0.378). The duration of HFNC ...
Nurse-led High-flow Nasal Cannula Weaning Protocol in ...
Evidence suggests that HFNC should be used effectively as a rescue treatment after standard oxygen therapy fails, serving as an intermediate step before ...
Comparing Efficacy of Three Strategies for Weaning of High ...
Group C exhibited the highest success rate (94.7%), followed by Group A (91.3%) and Group B (78.3%) (p = 0.218). The time to wean off HFNC was comparable across ...
5.
publications.aap.org
publications.aap.org/hospitalpediatrics/article-pdf/15/6/511/1803808/hosppeds.2024008141.pdfOptimizing High-Flow Nasal Cannula Weaning in Patients ...
CONCLUSIONS: Optimizing an HFNC weaning strategy resulted in a shorter HFNC duration and hospital LOS in children with bronchiolitis on HFNC.
High-flow weaning strategies for infants with bronchiolitis - PMC
We aim to conduct a pilot study to identify the most effective weaning strategy for infants, up to 12 months, supported on HFNC for bronchiolitis.
Comparison of Two Methods for Weaning from Nasal ...
In conclusion, employing HFNC for weaning from NCPAP resulted in longer hospital admissions and respiratory therapy days than the room air ...
Feasibility and safety of weaning premature infants from nasal ...
The median of SpO2 under NCPAP or HFNC in the success and failure groups were 98% vs. 97% and 98% vs. 97%, respectively. The median of cerebral ...
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