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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Time to weaning success
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •The patients applying high flow nasal cannula and satisfying the following weaning criteria.
- •Patient who has recovered from the underlying condition
- •No signs of respiratory distress like agitation, diaphoresis or anxiety
- •Arterial pH ≥ 7.35, SpO2 > 90% on FiO2 ≤ 0.5
- •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
Outcomes
Primary Outcomes
Time to weaning success
Time Frame: up to 2 weeks
The time to successfully remaining off high flow nasal cannula
Secondary Outcomes
- weaning success or failure rate(up to 2 weeks)
- change of arterial partial pressure of oxygen, carbon dioxide, and pH(up to 2 weeks)
- intolerance rate(up to 2 weeks)
- hospital length of stay(during hospital admission, up to 12 weeks)
- In-hospital mortality(during hospital admission, up to 12 weeks)
Investigators
Eun Sun Kim
Associate professor
Seoul National University Bundang Hospital