High Flow Nasal Oxygen During Sedation

Not Applicable

Completed

• Conditions: Cardiac Disease; Anesthesia
• Interventions: Device: Standard oxygenation; Device: High flow nasal oxygen

• Registration Number: NCT03858257
• Lead Sponsor: University Health Network, Toronto

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 Timeline

• Study First Submitted: 2019-02-25
• Study First Submitted QC: 2019-02-27
• Study First Posted: 2019-02-28
• Study Start: 2019-08-07
• Primary Completion: 2020-03-12
• Study Completion: 2020-03-12
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-09
• Last Update Posted: 2020-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 129

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard oxygenation	Standard oxygenation	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.
High flow nasal oxygen	High flow nasal oxygen	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.

Primary Outcome Measures

Name	Time	Method
Peak transcutaneous carbon dioxide (TcCO2) concentration.	From the time between first sedative medication administration to the end of the procedure. Estimated duration of procedures is 30 minutes to 120 minutes.	Continuous measurements will be recorded using the Sentec Digital Monitoring with VSign 2 sensor.

Secondary Outcome Measures

Name	Time	Method
Anesthesia Assistant rating of difficulty maintaining the patient's oxygenation status	To be completed as soon as possible after the end of the procedure (within about 5 minutes).	The Anaesthesia Assistant will be asked to rate their perceived level of difficulty in maintaining oxygenation using a 6-level rating scale with ratings of "extremely difficult", "very difficult", "difficult", "easy", "very easy", "extremely easy".
Anesthesia Assistant rating of difficulty using oxygen delivery device	To be completed as soon as possible after the end of the procedure (within about 5 minutes).	The Anaesthesia Assistant will be asked to rate their perceived level of difficulty using the oxygen delivery device using a 6-level rating scale with ratings of "extremely difficult", "very difficult", "difficult", "easy", "very easy", "extremely easy".
Costs associated with oxygen delivery	From the time between first sedative medication administration to the end of the procedure. Estimated duration of procedures is 30 minutes to 120 minutes.	Anesthesia Assistants will document devices used for supplemental oxygen delivery and airway management in both groups as per their usual practice in the anesthesia monitoring system.
Adverse sedation events	From the time between first sedative medication administration to the end of the procedure. Estimated duration of procedures is 30 minutes to 120 minutes.	The Anaesthesia Assistant will be asked to complete the Tracking and reporting outcomes of procedural sedation (TROOPS) tool at the end of procedures. Completion of the tool requires identification and description of the adverse event, the intervention, the outcome and the overall severity of the adverse event.
Patient satisfaction with sedation: Iowa Satisfaction with Anesthesia Scale	After the participant has reached phase 2 post-anesthetic recovery. Estimated to be 30 minutes after procedure has finished.	Iowa Satisfaction with Anesthesia Scale. Score ranges from -3 (worse satisfaction) to +3 (better satisfaction).
Patient comfort of oxygen delivery	After the participant has reached phase 2 post-anesthetic recovery. Estimated to be 30 minutes after procedure has finished.	Participants will be asked to rate at the end of procedures their perceived overall comfort with the oxygen delivery device used during the procedure using a 6-level rating scale with ratings of 'maximal discomfort', 'very uncomfortable', 'uncomfortable', 'comfortable', 'very comfortable' and 'maximal comfort'.
Mean transcutaneous carbon dioxide concentration	From the time between first sedative medication administration to the end of the procedure. Estimated duration of procedures is 30 minutes to 120 minutes.	Continuous measurements will be recorded using the Sentec Digital Monitoring with VSign 2 sensor.
Area under SpO2 90% oxygen desaturation curve	From the time between first sedative medication administration to the end of the procedure. Estimated duration of procedures is 30 minutes to 120 minutes.	Percentage of hemoglobin saturated with oxygen (SpO2) will be measured continuously throughout procedures as part of routine clinical practice through the anaesthetic machine. This is a composite measure comprising the incidence, depth, and duration of oxygen desaturation events. Area under SpO2 90% oxygen desaturation curve is calculated as the difference between the threshold (90%) and actual oxygen saturation (SpO2) summed every second during which oxygen saturation was below threshold.
Trajectory of transcutaneous carbon dioxide as a function of time	From the time between first sedative medication administration to the end of the procedure. Estimated duration of procedures is 30 minutes to 120 minutes.	Continuous measurements will be recorded using the Sentec Digital Monitoring with VSign 2 sensor

Trial Locations

Locations (1)

Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada