Weaning Protocol for High Flow Nasal Cannula Oxygen Therapy (SLOWH)

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

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Insufficiency; High Flow Nasal Cannula
• Intervention / Treatment: Device: Flow reduction first; Device: FiO2 reduction first; Device: Simultaneous (flow and FiO2) reduction

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Eun Sun Kim, MD, Seoul National University Bundang Hospital

Publications and helpful links

General Publications

• Kim MC, Lee YJ, Park JS, Cho YJ, Yoon HI, Lee CT, Lee JH, Kim ES. Simultaneous reduction of flow and fraction of inspired oxygen (FiO2) versus reduction of flow first or FiO2 first in patients ready to be weaned from high-flow nasal cannula oxygen therapy: study protocol for a randomized controlled trial (SLOWH trial). Trials. 2020 Jan 14;21(1):81. doi: 10.1186/s13063-019-4019-7.

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2019
• Primary Completion (Actual): March 31, 2024
• Study Completion (Actual): March 31, 2024

Study Registration Dates

• First Submitted: February 11, 2019
• First Submitted That Met QC Criteria: February 15, 2019
• First Posted (Actual): February 19, 2019

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: adult; weaning; high flow nasal cannula
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: B-1809-492-006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No