Back to resultsWeaning Protocol for High Flow Nasal Cannula Oxygen Therapy (SLOWH)
Primary Purpose
High Flow Nasal Cannula, Respiratory Insufficiency
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Flow reduction first
FiO2 reduction first
Simultaneous (flow and FiO2) reduction
Sponsored by
About this trial
This is an interventional supportive care trial for High Flow Nasal Cannula focused on measuring high flow nasal cannula, weaning, adult
Eligibility Criteria
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
Sites / Locations
- Seoul National University Bundang HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Flow reduction first group
FiO2 reduction first group
Simultaneous reduction group
Arm Description
Flow reduction first -> FiO2 reduction -> conventional oxygen therapy
FiO2 reduction first -> flow reduction -> conventional oxygen therapy
Simultaneous (Flow and FiO2) reduction -> conventional oxygen therapy
Outcomes
Primary Outcome Measures
Time to weaning success
The time to successfully remaining off high flow nasal cannula
Secondary Outcome Measures
weaning success or failure rate
Success or failure rate to wean off high flow nasal cannula
change of arterial partial pressure of oxygen, carbon dioxide, and pH
changes of arterial blood gas analyses
intolerance rate
intolerance to high flow nasal cannula
hospital length of stay
hospital length of stay
In-hospital mortality
all cause mortality
Full Information
NCT ID
NCT03845244
First Posted
February 11, 2019
Last Updated
April 10, 2023
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03845244
Brief Title
Weaning Protocol for High Flow Nasal Cannula Oxygen Therapy
Acronym
SLOWH
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
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 24, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Flow Nasal Cannula, Respiratory Insufficiency
Keywords
high flow nasal cannula, weaning, adult
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Flow reduction first group
Arm Type
Active Comparator
Arm Description
Flow reduction first -> FiO2 reduction -> conventional oxygen therapy
Arm Title
FiO2 reduction first group
Arm Type
Active Comparator
Arm Description
FiO2 reduction first -> flow reduction -> conventional oxygen therapy
Arm Title
Simultaneous reduction group
Arm Type
Active Comparator
Arm Description
Simultaneous (Flow and FiO2) reduction -> conventional oxygen therapy
Intervention Type
Device
Intervention Name(s)
Flow reduction first
Intervention Description
-10L/min q 1hr
Intervention Type
Device
Intervention Name(s)
FiO2 reduction first
Intervention Description
- 0.1 q 1hr
Intervention Type
Device
Intervention Name(s)
Simultaneous (flow and FiO2) reduction
Intervention Description
-10L/min and -0.1 q 1hr
Primary Outcome Measure Information:
Title
Time to weaning success
Description
The time to successfully remaining off high flow nasal cannula
Time Frame
up to 2 weeks
Secondary Outcome Measure Information:
Title
weaning success or failure rate
Description
Success or failure rate to wean off high flow nasal cannula
Time Frame
up to 2 weeks
Title
change of arterial partial pressure of oxygen, carbon dioxide, and pH
Description
changes of arterial blood gas analyses
Time Frame
up to 2 weeks
Title
intolerance rate
Description
intolerance to high flow nasal cannula
Time Frame
up to 2 weeks
Title
hospital length of stay
Description
hospital length of stay
Time Frame
during hospital admission, up to 12 weeks
Title
In-hospital mortality
Description
all cause mortality
Time Frame
during hospital admission, up to 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eun Sun Kim, MD
Phone
+82-31-787-7086
Email
apolio3700@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eun Sun Kim, MD
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eun Sun Kim, MD
Phone
+82-31-787-7086
Email
apolio3700@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31937322
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.
Results Reference
derived
Learn more about this trial
Weaning Protocol for High Flow Nasal Cannula Oxygen Therapy
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