Protocolized Weaning of High-Flow Nasal Cannula in Adult Patients

Official title

Protocolized Weaning of High-Flow Nasal Cannula in Adult Patients: A Stepped-Wedge Cluster Randomized Trial (PRO-WEAN HFNC)

Overview

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.

Interventions

• 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.
• Behavioral Usual Care HFNC Weaning
  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.

Primary outcome measures

• Proportion of patients successfully weaned from HFNC on day 5 of study enrollment [Time frame: Up to 5 days after study enrollment]

Secondary outcome measures (12)

• 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]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Rush University Medical Center — Chicago

Identifiers

NCT: NCT07452406 · HFNC weaning

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗