Clinical trial NCT03845244: Weaning Protocol for High Flow Nasal Cannula Oxygen Therapy
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High Flow Nasal Cannula
Respiratory Insufficiency
Keywords: high flow nasal cannula
weaning
adult
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2019-02-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: 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

Primary outcomes:
measure: Time to weaning success
timeFrame: up to 2 weeks
Secondary outcomes:
measure: weaning success or failure rate
timeFrame: up to 2 weeks
measure: change of arterial partial pressure of oxygen, carbon dioxide, and pH
timeFrame: up to 2 weeks
measure: intolerance rate
timeFrame: up to 2 weeks
measure: hospital length of stay
timeFrame: during hospital admission, up to 12 weeks
measure: In-hospital mortality
timeFrame: during hospital admission, up to 12 weeks
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Eun Sun Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.