Weaning Protocol for High Flow Nasal Cannula Oxygen Therapy

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

Official Title
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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

Conditions
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High Flow Nasal Cannula, Respiratory Insufficiency

Intervention / Treatment
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* Device: Flow reduction first
* Device: FiO2 reduction first
* Device: Simultaneous (flow and FiO2) reduction


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Flow reduction first group<br>Flow reduction first -> FiO2 reduction -> conventional oxygen therapy | Device: Flow reduction first<br>* -10L/min q 1hr<br>|
| Active Comparator: FiO2 reduction first group<br>FiO2 reduction first -> flow reduction -> conventional oxygen therapy | Device: FiO2 reduction first<br>* - 0.1 q 1hr<br>|
| Active Comparator: Simultaneous reduction group<br>Simultaneous (Flow and FiO2) reduction -> conventional oxygen therapy | Device: Simultaneous (flow and FiO2) reduction<br>* -10L/min and -0.1 q 1hr<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to weaning success | The time to successfully remaining off high flow nasal cannula | up to 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weaning success or failure rate | Success or failure rate to wean off high flow nasal cannula | up to 2 weeks | 
| change of arterial partial pressure of oxygen, carbon dioxide, and pH | changes of arterial blood gas analyses | up to 2 weeks | 
| intolerance rate | intolerance to high flow nasal cannula | up to 2 weeks | 
| hospital length of stay | hospital length of stay | during hospital admission, up to 12 weeks | 
| In-hospital mortality | all cause mortality | during hospital admission, up to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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high flow nasal cannula, weaning, adult