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Completed

NCT Number: NCT03858257

High Flow Nasal Oxygen During Sedation

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.

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Key information

Conditions

Anesthesia Cardiac Disease Cardiovascular Diseases Heart Diseases Hypercapnia Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Insufficiency Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Toronto General Hospital

Toronto, Ontario, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Exclusion criteria

  • Under 16 years of age.
  • Underlying condition requiring chronic oxygen supplementation.
  • Diagnosed respiratory condition with confirmed current hypercapnia.
  • Pre-existing untreated pneumothorax.
  • Transesophageal echocardiography planned for the procedure.
  • Active nasal bleeding.
  • Complete nasal obstruction.
  • Recent upper airway surgery or base of skull fracture.
  • Previous participation in the study.

Treatment and study plan

high flow nasal oxygen

Device

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

Standard oxygenation

Device

Supplemental oxygen through a facemask.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 28, 2019
Registry last updated
Nov 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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