Protocolized Weaning of High-Flow Nasal Cannula in Adult Patients

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Rush University Medical Center
Study ID
NCT07452406
Status
Not Yet Recruiting

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Conditions

  • Acute Hypoxemic Respiratory Failure
  • High-Flow Nasal Cannula Therapy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Sep 1, 2026
Status verified
Jun 2026
Primary completion
Mar 31, 2028
Completion
Jun 28, 2028

Study Design

Enrollment
2,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Usual Care HFNC Weaning
    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.
  • Experimental: Protocolized 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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Rush University Medical CenterChicagoIllinois60612-

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By research site
Rush University Medical Center· Chicago, IL

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