High Flow Nasal Oxygen During Sedation

• ClinicalTrials.gov Identifier: NCT03858257
• Recruitment Status: Completed
• First Posted: February 28, 2019
• Last Update Posted: November 12, 2020
• Sponsor: University Health Network, Toronto
• Information provided by (Responsible Party): Aaron Conway, University Health Network, Toronto

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	Not Applicable

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 (Clinical Trial)
• 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: August 7, 2019
• Actual Primary Completion Date: March 12, 2020
• Actual Study Completion Date: March 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.
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 :

1. Peak transcutaneous carbon dioxide (TcCO2) concentration. [ Time Frame: 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 :

1. Mean transcutaneous carbon dioxide concentration [ Time Frame: 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.
2. Area under SpO2 90% oxygen desaturation curve [ Time Frame: 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.
3. Adverse sedation events [ Time Frame: 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.
4. Patient satisfaction with sedation: Iowa Satisfaction with Anesthesia Scale [ Time Frame: 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).
5. Costs associated with oxygen delivery [ Time Frame: 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.
6. Anesthesia Assistant rating of difficulty maintaining the patient's oxygenation status [ Time Frame: 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".
7. Anesthesia Assistant rating of difficulty using oxygen delivery device [ Time Frame: 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".
8. Patient comfort of oxygen delivery [ Time Frame: 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'.
9. Trajectory of transcutaneous carbon dioxide as a function of time [ Time Frame: 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

• Ages Eligible for Study: 16 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Canada, Ontario

Toronto General Hospital

Toronto, Ontario, Canada

Sponsors and Collaborators

University Health Network, Toronto

Investigators

• Principal Investigator: Aaron Conway, RN, PhD; University Health Network, Toronto

  Study Documents (Full-Text)

Documents provided by Aaron Conway, University Health Network, Toronto:

Study Protocol and Statistical Analysis Plan  [PDF] June 6, 2019

More Information

• Responsible Party: Aaron Conway, RBC Chair in Cardiovascular Nursing Research, University Health Network, Toronto
• ClinicalTrials.gov Identifier: NCT03858257
• Other Study ID Numbers: 18-6343
• First Posted: February 28, 2019
• Last Update Posted: November 12, 2020
• Last Verified: November 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Study data, participant-level data sets (without identifying information) and code for statistical analyses will be shared in a publicly accessible repository at the time of publication.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Analytic Code
• Time Frame: With publication of results.
• Access Criteria: Available through a public repository

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Aaron Conway, University Health Network, Toronto:

Oxygen; Ventilation; High-flow nasal oxygen; Hypercapnia; Respiratory depression; Respiratory compromise; Carbon dioxide; Transcutaneous carbon dioxide

Additional relevant MeSH terms:

Heart Diseases; Cardiovascular Diseases