AnesthesiaNCT03858257
High Flow Nasal Oxygen During Sedation
A study testing High flow nasal oxygen and Standard oxygenation in people with Anesthesia and Cardiac Disease, run by University Health Network, Toronto at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Anesthesia, Cardiac Disease
- What is being tested?
- High flow nasal oxygen and Standard oxygenation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteCanada
- Study dates
- 7 Aug 2019to 12 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 9Show fewer
- Complete nasal obstruction.
- Recent upper airway surgery or base of skull fracture.
- Previous participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High Flow Nasal Oxygen During Conscious Sedation in the Cardiac Catheterisation Laboratory: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Anesthesia, Cardiac Disease
- Being tested
- High flow nasal oxygen, Standard oxygenation
- Keywords
- Oxygen, Ventilation, High-flow nasal oxygen, Hypercapnia, Respiratory depression, Respiratory compromise, Carbon dioxide, Transcutaneous carbon dioxide
- Medical subject headings
- Heart Diseases, Respiratory Aspiration, Hypercapnia, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High flow nasal oxygenDevice
The Optiflow device (Fisher and Paykel Healthcare, Auckland, New Zealand) will be used.
Standard oxygenationDevice
Supplemental oxygen through a facemask.
| Study group | Role | What they receive |
|---|---|---|
| High flow nasal oxygen | Experimental | 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. Receives: Device: High flow nasal oxygen |
| Standard oxygenation | Other | 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. Receives: Device: Standard oxygenation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak transcutaneous carbon dioxide (TcCO2) concentration.
Continuous measurements will be recorded using the Sentec Digital Monitoring with VSign 2 sensor.
Measured: 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 (9)
Mean transcutaneous carbon dioxide concentration
Continuous measurements will be recorded using the Sentec Digital Monitoring with VSign 2 sensor.
Measured: From the time between first sedative medication administration to the end of the procedure. Estimated duration of procedures is 30 minutes to 120 minutes.
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.
Measured: From the time between first sedative medication administration to the end of the procedure. Estimated duration of procedures is 30 minutes to 120 minutes.
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.
Measured: From the time between first sedative medication administration to the end of the procedure. Estimated duration of procedures is 30 minutes to 120 minutes.
Patient satisfaction with sedation: Iowa Satisfaction with Anesthesia Scale
Iowa Satisfaction with Anesthesia Scale. Score ranges from -3 (worse satisfaction) to +3 (better satisfaction).
Measured: After the participant has reached phase 2 post-anesthetic recovery. Estimated to be 30 minutes after procedure has finished.
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.
Measured: 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 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".
Measured: To be completed as soon as possible after the end of the procedure (within about 5 minutes).
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".
Measured: To be completed as soon as possible after the end of the procedure (within about 5 minutes).
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'.
Measured: After the participant has reached phase 2 post-anesthetic recovery. Estimated to be 30 minutes after procedure has finished.
Trajectory of transcutaneous carbon dioxide as a function of time
Continuous measurements will be recorded using the Sentec Digital Monitoring with VSign 2 sensor
Measured: From the time between first sedative medication administration to the end of the procedure. Estimated duration of procedures is 30 minutes to 120 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2019
- Study start7 Aug 2019
- Primary completion12 Mar 2020
- Study completion12 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aaron Conway, University Health Network, Toronto
- Investigators
- Aaron Conway, RN, PhD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03858257
- Sponsor's protocol ID
- 18-6343
- Status last verified
- Nov 2020
- First submitted
- 25 Feb 2019
- Last updated
- 12 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 33492872
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Flow Nasal Oxygen During Conscious Sedation in the Cardiac Catheterisation Laboratory: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03858257
- Acronym / sponsor ID
- 18-6343
- Conditions
- Anesthesia, Cardiac Disease
- Keywords
- Oxygen, Ventilation, High-flow nasal oxygen, Hypercapnia, Respiratory depression, Respiratory compromise, Carbon dioxide, Transcutaneous carbon dioxide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 7 Aug 2019 (actual)
- Primary completion
- 12 Mar 2020 (actual)
- Study completion
- 12 Mar 2020 (actual)
- First posted
- 28 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High flow nasal oxygen | Experimental | Device: High flow nasal oxygenThe 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. |
| Standard oxygenation | Other | Device: Standard oxygenationSupplemental 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High flow nasal oxygenThe Optiflow device (Fisher and Paykel Healthcare, Auckland, New Zealand) will be used. | Device | High flow nasal oxygen |
| Standard oxygenationSupplemental oxygen through a facemask. | Device | Standard oxygenation |
Primary outcome
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.
9 secondary outcomes
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.
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.
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.
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.
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 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).
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).
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2020.
- Derived from this study: PubMed 33492872Conway 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aaron Conway, RN, PhD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High flow nasal oxygen and Standard oxygenation in people with Anesthesia and Cardiac Disease, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03858257, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2020.