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NCT03845244 Clinical Trial

Weaning Protocol for High Flow Nasal Cannula Oxygen Therapy

Respiratory Insufficiency Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03845244
Other study ID # B-1809-492-006
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 24, 2019
Est. completion date March 31, 2024

Study information
Verified date April 2024
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date March 31, 2024
Est. primary completion date March 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• Flow reduction first
-10L/min q 1hr
• FiO2 reduction first
- 0.1 q 1hr
• Simultaneous (flow and FiO2) reduction
-10L/min and -0.1 q 1hr

Locations
Country Name City State
Korea, Republic of Seoul National University Bundang Hospital Seongnam-si Gyeonggi-do

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Time to weaning success The time to successfully remaining off high flow nasal cannula up to 2 weeks
Secondary weaning success or failure rate Success or failure rate to wean off high flow nasal cannula up to 2 weeks
Secondary change of arterial partial pressure of oxygen, carbon dioxide, and pH changes of arterial blood gas analyses up to 2 weeks
Secondary intolerance rate intolerance to high flow nasal cannula up to 2 weeks
Secondary hospital length of stay hospital length of stay during hospital admission, up to 12 weeks
Secondary In-hospital mortality all cause mortality during hospital admission, up to 12 weeks
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