Weaning Protocol for High Flow Nasal Cannula Oxygen Therapy

Not Applicable

Completed

• Conditions: High Flow Nasal Cannula; Respiratory Insufficiency
• Interventions: Device: Flow reduction first; Device: FiO2 reduction first; Device: Simultaneous (flow and FiO2) reduction

• Registration Number: NCT03845244
• Lead Sponsor: Seoul National University Hospital

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 Timeline

• Study Start: 2019-01-24
• Study First Submitted: 2019-02-11
• Study First Submitted QC: 2019-02-15
• Study First Posted: 2019-02-19
• Primary Completion: 2024-03-31
• Study Completion: 2024-03-31
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-17
• Last Update Posted: 2024-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Flow reduction first group	Flow reduction first	Flow reduction first -\> FiO2 reduction -\> conventional oxygen therapy
FiO2 reduction first group	FiO2 reduction first	FiO2 reduction first -\> flow reduction -\> conventional oxygen therapy
Simultaneous reduction group	Simultaneous (flow and FiO2) reduction	Simultaneous (Flow and FiO2) reduction -\> conventional oxygen therapy

Primary Outcome Measures

Name	Time	Method
Time to weaning success	up to 2 weeks	The time to successfully remaining off high flow nasal cannula

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of