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Clinical Trials/NCT03845244
NCT03845244
Completed
Not Applicable

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

Seoul National University Hospital1 site in 1 country100 target enrollmentJanuary 24, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
High Flow Nasal Cannula
Sponsor
Seoul National University Hospital
Enrollment
100
Locations
1
Primary Endpoint
Time to weaning success
Status
Completed
Last Updated
2 years ago

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

Registry
clinicaltrials.gov
Start Date
January 24, 2019
End Date
March 31, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Eun Sun Kim

Associate professor

Seoul National University Bundang Hospital

Eligibility Criteria

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)

Study Sites (1)

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