Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2026-01-01 @ 1:25 PM
Study NCT ID:
NCT03858257
Status:
COMPLETED
Last Update Posted:
2020-11-12
First Post:
2019-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High Flow Nasal Oxygen During Sedation
Sponsor:
University Health Network, Toronto
Organization:
Study Overview
Official Title:
High Flow Nasal Oxygen During Conscious Sedation in the Cardiac Catheterisation Laboratory: A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this study is to test the hypothesis that using high flow nasal oxygen improves ventilation during cardiac implantable electronic device procedures performed with conscious sedation. A randomized controlled trial design will be used with participants randomized in a 1:1 ratio to oxygen supplementation through a standard facemask or high flow nasal oxygen.
Detailed Description:
High flow nasal oxygen (HFNO) is increasingly regarded as a promising technology for oxygen delivery in critical care and anesthetic management. Although promising, further high-quality studies examining the effects of using HFNO during procedural sedation are required to inform decision-making regarding implementation of this new technology into practice. The 2018 guidelines from the American Society of Anesthesiology stated that there is insufficient evidence regarding which methods of supplemental oxygen administration (e.g., nasal cannula, face mask, or specialized devices such as HFNO) are more effective. This trial will address this limitation in the evidence base specifically in regard to the efficacy of using HFNO during conscious sedation in the cardiac catheterisation laboratory.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: