High Flow Nasal Oxygen During Sedation

Sponsor

University Health Network, Toronto (Other)

Overall Status

Completed

CT.gov ID

NCT03858257

Collaborator

(none)

129

Enrollment

Location

Arms

7.2

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia Cardiac Disease	Device: High flow nasal oxygen Device: Standard oxygenation	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

129 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Aug 7, 2019

Actual Primary Completion Date :

Mar 12, 2020

Actual Study Completion Date :

Mar 12, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: High flow nasal oxygen The Optiflow device (Fisher and Paykel Healthcare, Auckland, New Zealand) will be used.
Other: 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.	Device: Standard oxygenation Supplemental oxygen through a facemask.

Arm

Intervention/Treatment

Experimental: 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.

Device: High flow nasal oxygen

The Optiflow device (Fisher and Paykel Healthcare, Auckland, New Zealand) will be used.

Other: 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.

Device: Standard oxygenation

Supplemental oxygen through a facemask.

Outcome Measures

Primary Outcome Measures

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

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.
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).
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.
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".
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'.
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria:

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).