- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03858257
High Flow Nasal Oxygen During Sedation
November 9, 2020 updated by: Aaron Conway, University Health Network, Toronto
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
129
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada
- Toronto General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
The Optiflow device (Fisher and Paykel Healthcare, Auckland, New Zealand) will be used.
|
Other: 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.
|
Supplemental oxygen through a facemask.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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).
|
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).
|
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".
|
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.
|
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.
|
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
|
From the time between first sedative medication administration to the end of the procedure. Estimated duration of procedures is 30 minutes to 120 minutes.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Aaron Conway, RN, PhD, University Health Network, Toronto
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 7, 2019
Primary Completion (Actual)
March 12, 2020
Study Completion (Actual)
March 12, 2020
Study Registration Dates
First Submitted
February 25, 2019
First Submitted That Met QC Criteria
February 27, 2019
First Posted (Actual)
February 28, 2019
Study Record Updates
Last Update Posted (Actual)
November 12, 2020
Last Update Submitted That Met QC Criteria
November 9, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-6343
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD 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.
IPD Sharing Time Frame
With publication of results.
IPD Sharing Access Criteria
Available through a public repository
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anesthesia
-
Samsun UniversityCompletedAnesthesia | Regional Anesthesia | Anesthesia ManagementTurkey
-
Charite University, Berlin, GermanyCompletedAnesthesia, Local | Anesthesia | Anesthesia; Adverse EffectGermany
-
Novocol Pharmaceutical of Canada, Inc.CompletedAnesthesia, Local | Dental Anesthesia | Anesthesia, ReversalUnited States
-
Aligarh Muslim UniversityCompletedAnesthesia | Anesthesia Intubation Complication | Anesthesia; Adverse EffectIndia
-
Universitas Sebelas MaretIndonesia Endowment Fund for EducationNot yet recruitingAnesthesia | Anesthesia; Reaction
-
University of PecsCompleted
-
Hormozgan University of Medical SciencesUnknownAnesthesia | Anesthesia; FunctionalIran, Islamic Republic of
-
University of ChicagoRecruitingAnesthesia | Patient Satisfaction | Anesthesia Risks | Anesthesia Consent | Consent RetentionUnited States
-
Assistance Publique - Hôpitaux de ParisINSERM UMR-942, Paris, France; M3DISIMRecruiting
-
Indonesia UniversityActive, not recruitingAnesthesia | Anesthesia; ReactionIndonesia
Clinical Trials on High flow nasal oxygen
-
Hamad Medical CorporationRecruitingHigh-flow Nasal Oxygen Therapy to Prevent Extubation Failure in Adult Trauma Intensive Care PatientsAirway Extubation | Critical Care | Intensive Care | Oxygen TherapyQatar
-
Centre Hospitalier Universitaire de BesanconCentre Hospitalier Universitaire Dijon; Poitiers University Hospital; University... and other collaboratorsRecruitingAcute Hypoxemic Respiratory DistressFrance
-
Henrik EndemanFranciscus Gasthuis; Maasstad HospitalRecruitingRespiratory Failure | Post Extubation Acute Respiratory Failure Requiring ReintubationNetherlands
-
National Taiwan University HospitalRecruitingEndoscopy, Gastrointestinal | Sedation, ConsciousTaiwan
-
Yonsei UniversityCompletedObstructive Sleep ApneaKorea, Republic of
-
Maastricht University Medical CenterRecruitingRadiofrequency Ablation | Deep Sedation | Oxygen TherapyNetherlands
-
Aga Khan University Hospital, PakistanUnknownApneic Oxygenation
-
Johns Hopkins UniversityThrasher Research Fund; University of North Carolina Project- Lilongwe, MalawiNot yet recruiting
-
Hospital Clinic of BarcelonaRecruitingAortic Stenosis | Sedation ComplicationSpain
-
University Hospitals of North Midlands NHS TrustRecruitingCancer of the EsophagusUnited Kingdom