Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Peak transcutaneous carbon dioxide (TcCO2) concentration. |
Continuous measurements will be recorded using the Sentec Digital Monitoring with VSign 2 sensor. |
From the time between first sedative medication administration to the end of the procedure. Estimated duration of procedures is 30 minutes to 120 minutes. |
|
Secondary |
Mean transcutaneous carbon dioxide concentration |
Continuous measurements will be recorded using the Sentec Digital Monitoring with VSign 2 sensor. |
From the time between first sedative medication administration to the end of the procedure. Estimated duration of procedures is 30 minutes to 120 minutes. |
|
Secondary |
Area under SpO2 90% oxygen desaturation curve |
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. |
From the time between first sedative medication administration to the end of the procedure. Estimated duration of procedures is 30 minutes to 120 minutes. |
|
Secondary |
Adverse sedation events |
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. |
From the time between first sedative medication administration to the end of the procedure. Estimated duration of procedures is 30 minutes to 120 minutes. |
|
Secondary |
Patient satisfaction with sedation: Iowa Satisfaction with Anesthesia Scale |
Iowa Satisfaction with Anesthesia Scale. Score ranges from -3 (worse satisfaction) to +3 (better satisfaction). |
After the participant has reached phase 2 post-anesthetic recovery. Estimated to be 30 minutes after procedure has finished. |
|
Secondary |
Costs associated with oxygen delivery |
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. |
From the time between first sedative medication administration to the end of the procedure. Estimated duration of procedures is 30 minutes to 120 minutes. |
|
Secondary |
Anesthesia Assistant rating of difficulty maintaining the patient's oxygenation status |
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". |
To be completed as soon as possible after the end of the procedure (within about 5 minutes). |
|
Secondary |
Anesthesia Assistant rating of difficulty using oxygen delivery device |
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". |
To be completed as soon as possible after the end of the procedure (within about 5 minutes). |
|
Secondary |
Patient comfort of oxygen delivery |
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'. |
After the participant has reached phase 2 post-anesthetic recovery. Estimated to be 30 minutes after procedure has finished. |
|
Secondary |
Trajectory of transcutaneous carbon dioxide as a function of time |
Continuous measurements will be recorded using the Sentec Digital Monitoring with VSign 2 sensor |
From the time between first sedative medication administration to the end of the procedure. Estimated duration of procedures is 30 minutes to 120 minutes. |
|