High Flow Nasal Oxygen During Sedation

University Health Network, Toronto

Status: Completed

Conditions: Cardiac Disease; Anesthesia

Treatments: Device: High flow nasal oxygen; Device: Standard oxygenation

Study type: Interventional

Funder types: Other

Identifiers

NCT03858257

18-6343

Details and patient eligibility

About

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.

Full 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.

Enrollment: 129 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adults undergoing an elective cardiac implantable electronic device procedure in the Peter Munk Cardiac Centre Cardiac Cath Labs with conscious sedation administered by an Anesthetic Assistant (de novo and replacement/revision procedures).

Exclusion criteria

1. Under 16 years of age.
2. Underlying condition requiring chronic oxygen supplementation.
3. Diagnosed respiratory condition with confirmed current hypercapnia.
4. Pre-existing untreated pneumothorax.
5. Transesophageal echocardiography planned for the procedure.
6. Active nasal bleeding.
7. Complete nasal obstruction.
8. Recent upper airway surgery or base of skull fracture.
9. Previous participation in the study.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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129 participants in 2 patient groups

High flow nasal oxygen

Experimental group

Description:

The gas temperature will commence at the 'High' setting (ranges 30-32º Celsius) and titrated downwards if the patient complains of irritation. The gas flow rate will commence at 30 liters per minute prior to sedation administration and be titrated up to 70 liters per minute as tolerated by the patient after sedation has been administered. The fraction of oxygen in the gas will be commenced at 50% (same as that delivered from 6 liters per minute via facemask) and can be titrated upward according to patient requirements (i.e. increased if there is evidence of hypoventilation, airway obstruction or inadequate oxygenation, decreased during use of diathermy). Anesthesia Assistants at the site will be provided with training in the use of this mode of oxygen delivery prior to study commencement.

Treatment:

Device: High flow nasal oxygen

Standard oxygenation

Other group

Description:

Supplemental oxygen through a facemask with the flow rate chosen by the clinician responsible for sedation as per their standard practice. The oxygen flow rate is typically commenced at 6 liters per minute and can be titrated up to 15 liters per minute.

Treatment:

Device: Standard oxygenation