NCT03845244

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 24, 2019

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

February 11, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 19, 2019

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

April 18, 2024

Status Verified

April 1, 2024

Enrollment Period

5.2 years

First QC Date

February 11, 2019

Last Update Submit

April 17, 2024

Conditions

High Flow Nasal CannulaRespiratory Insufficiency

Keywords

high flow nasal cannulaweaningadult

Outcome Measures

Primary Outcomes (1)

  • Time to weaning success

    The time to successfully remaining off high flow nasal cannula

    up to 2 weeks

Secondary Outcomes (5)

  • weaning success or failure rate

    up to 2 weeks

  • change of arterial partial pressure of oxygen, carbon dioxide, and pH

    up to 2 weeks

  • intolerance rate

    up to 2 weeks

  • hospital length of stay

    during hospital admission, up to 12 weeks

  • In-hospital mortality

    during hospital admission, up to 12 weeks

Study Arms (3)

Flow reduction first group

ACTIVE COMPARATOR

Flow reduction first -\> FiO2 reduction -\> conventional oxygen therapy

Device: Flow reduction first

FiO2 reduction first group

ACTIVE COMPARATOR

FiO2 reduction first -\> flow reduction -\> conventional oxygen therapy

Device: FiO2 reduction first

Simultaneous reduction group

ACTIVE COMPARATOR

Simultaneous (Flow and FiO2) reduction -\> conventional oxygen therapy

Device: Simultaneous (flow and FiO2) reduction

Interventions

Flow reduction firstDEVICE

-10L/min q 1hr

Flow reduction first group
FiO2 reduction firstDEVICE

\- 0.1 q 1hr

FiO2 reduction first group
Simultaneous (flow and FiO2) reductionDEVICE

-10L/min and -0.1 q 1hr

Simultaneous reduction group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

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

Location

Related Publications (1)

  • 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.

    PMID: 31937322DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • Eun Sun Kim, MD

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

February 11, 2019

First Posted

February 19, 2019

Study Start

January 24, 2019

Primary Completion

March 31, 2024

Study Completion

March 31, 2024

Last Updated

April 18, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)