Clinical trial NCT03858257: High Flow Nasal Oxygen During Sedation
Official title: High Flow Nasal Oxygen During Conscious Sedation in the Cardiac Catheterisation Laboratory: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Cardiac Disease
Keywords: Oxygen
Ventilation
High-flow nasal oxygen
Hypercapnia
Respiratory depression
Respiratory compromise
Carbon dioxide
Transcutaneous carbon dioxide
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2019-02-28
Enrollment: 129
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Peak transcutaneous carbon dioxide (TcCO2) concentration.
timeFrame: 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 outcomes:
measure: Mean transcutaneous carbon dioxide concentration
timeFrame: From the time between first sedative medication administration to the end of the procedure. Estimated duration of procedures is 30 minutes to 120 minutes.
measure: Area under SpO2 90% oxygen desaturation curve
timeFrame: From the time between first sedative medication administration to the end of the procedure. Estimated duration of procedures is 30 minutes to 120 minutes.
measure: Adverse sedation events
timeFrame: From the time between first sedative medication administration to the end of the procedure. Estimated duration of procedures is 30 minutes to 120 minutes.
measure: Patient satisfaction with sedation: Iowa Satisfaction with Anesthesia Scale
timeFrame: After the participant has reached phase 2 post-anesthetic recovery. Estimated to be 30 minutes after procedure has finished.
measure: Costs associated with oxygen delivery
timeFrame: From the time between first sedative medication administration to the end of the procedure. Estimated duration of procedures is 30 minutes to 120 minutes.
measure: Anesthesia Assistant rating of difficulty maintaining the patient's oxygenation status
timeFrame: To be completed as soon as possible after the end of the procedure (within about 5 minutes).
measure: Anesthesia Assistant rating of difficulty using oxygen delivery device
timeFrame: To be completed as soon as possible after the end of the procedure (within about 5 minutes).
measure: Patient comfort of oxygen delivery
timeFrame: After the participant has reached phase 2 post-anesthetic recovery. Estimated to be 30 minutes after procedure has finished.
measure: Trajectory of transcutaneous carbon dioxide as a function of time
timeFrame: From the time between first sedative medication administration to the end of the procedure. Estimated duration of procedures is 30 minutes to 120 minutes.
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Aaron Conway, RN, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Conway A, Collins P, Chang K, Kamboj N, Filici AL, Lam P, Parotto M. High flow nasal oxygen during procedural sedation for cardiac implantable electronic device procedures: A randomised controlled trial. Eur J Anaesthesiol. 2021 Aug 1;38(8):839-849. doi: 10.1097/EJA.0000000000001458.