Clinical Trials Directory

Trials / Completed

CompletedNCT03858257

High Flow Nasal Oxygen During Sedation

High Flow Nasal Oxygen During Conscious Sedation in the Cardiac Catheterisation Laboratory: A Randomized Controlled Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
129 (actual)
Sponsor
University Health Network, Toronto · Academic / Other
Sex
All
Age
16 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEHigh flow nasal oxygenThe Optiflow device (Fisher and Paykel Healthcare, Auckland, New Zealand) will be used.
DEVICEStandard oxygenationSupplemental oxygen through a facemask.

Timeline

Start date
2019-08-07
Primary completion
2020-03-12
Completion
2020-03-12
First posted
2019-02-28
Last updated
2020-11-12

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT03858257. Inclusion in this directory is not an endorsement.