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NCT Number: NCT03845244

Weaning Protocol for High Flow Nasal Cannula Oxygen Therapy

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.

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Key information

Conditions

High Flow Nasal Cannula Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Flow reduction first

Device

-10L/min q 1hr

FiO2 reduction first

Device
  • 0.1 q 1hr

Simultaneous (flow and FiO2) reduction

Device

-10L/min and -0.1 q 1hr

Primary outcomes

  1. Time to weaning success

    Time frame: up to 2 weeks

    The time to successfully remaining off high flow nasal cannula

Secondary outcomes

  1. weaning success or failure rate

    Time frame: up to 2 weeks

    Success or failure rate to wean off high flow nasal cannula

  2. change of arterial partial pressure of oxygen, carbon dioxide, and pH

    Time frame: up to 2 weeks

    changes of arterial blood gas analyses

  3. intolerance rate

    Time frame: up to 2 weeks

    intolerance to high flow nasal cannula

  4. hospital length of stay

    Time frame: during hospital admission, up to 12 weeks

    hospital length of stay

  5. In-hospital mortality

    Time frame: during hospital admission, up to 12 weeks

    all cause mortality

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Acronym: SLOWH

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Feb 19, 2019
Registry last updated
Apr 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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