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Weaning Protocol for High Flow Nasal Cannula Oxygen Therapy

Simultaneous Reduction Versus Flow or Fraction of Inspired Oxygen Reduction First in Patients Ready to Wean From High Flow Nasal Cannula Oxygen Therapy: a Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03845244
Acronym
SLOWH
Enrollment
100
Registered
2019-02-19
Start date
2019-01-24
Completion date
2024-03-31
Last updated
2024-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High Flow Nasal Cannula, Respiratory Insufficiency

Keywords

high flow nasal cannula, weaning, adult

Brief summary

High flow nasal cannula oxygen therapy has been widely used in critically ill patients. Despite effectiveness of high flow nasal cannula as a treatment, optimal methods to withdrawal high flow nasal cannula after recovery from preexisting conditions has not been investigated to date. In this study, we will evaluate the efficacy and safety of three different weaning methods in patients with high flow nasal cannula oxygen therapy.

Detailed description

Comparison of three weaning strategies: flow reduction first versus fraction of inspired oxygen (FiO2) first versus simultaneous reduction

Interventions

DEVICEFlow reduction first

-10L/min q 1hr

DEVICEFiO2 reduction first

\- 0.1 q 1hr

DEVICESimultaneous (flow and FiO2) reduction

-10L/min and -0.1 q 1hr

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* The patients applying high flow nasal cannula and satisfying the following weaning criteria. 1. Patient who has recovered from the underlying condition 2. No signs of respiratory distress like agitation, diaphoresis or anxiety 3. Arterial pH ≥ 7.35, SpO2 \> 90% on FiO2 ≤ 0.5 4. Respiratory rate ≤ 25/min, Heart rate ≤120/min, Systolic blood pressure ≥ 90mmHg

Exclusion criteria

* Severe hypercapnia (pH \<7.25) * Respiratory arrest requiring tracheal intubation * Cardiac arrest, acute coronary syndrome or life threatening arrhythmias * Failure of more than two organs * Recent trauma or burns of the neck and face * Non- cooperation * Pregnancy * Refusal of treatment

Design outcomes

Primary

MeasureTime frameDescription
Time to weaning successup to 2 weeksThe time to successfully remaining off high flow nasal cannula

Secondary

MeasureTime frameDescription
weaning success or failure rateup to 2 weeksSuccess or failure rate to wean off high flow nasal cannula
change of arterial partial pressure of oxygen, carbon dioxide, and pHup to 2 weekschanges of arterial blood gas analyses
intolerance rateup to 2 weeksintolerance to high flow nasal cannula
hospital length of stayduring hospital admission, up to 12 weekshospital length of stay
In-hospital mortalityduring hospital admission, up to 12 weeksall cause mortality

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026