High Flow Nasal Oxygen During Sedation

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03858257
• Other study ID #: 18-6343
• Status: Completed
• Phase: N/A
• Start date: August 7, 2019
• Est. completion date: March 12, 2020

Study information

• Verified date: November 2020
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: March 12, 2020
• Est. primary completion date: March 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia
• Cardiac Disease
• Heart Diseases

Intervention

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

Locations

Country	Name	City	State
Canada	Toronto General Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

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.