NCT03858257

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
129

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 28, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

August 7, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 12, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 12, 2020

Completed
Last Updated

November 12, 2020

Status Verified

November 1, 2020

Enrollment Period

7 months

First QC Date

February 25, 2019

Last Update Submit

November 9, 2020

Conditions

AnesthesiaCardiac Disease

Keywords

OxygenVentilationHigh-flow nasal oxygenHypercapniaRespiratory depressionRespiratory compromiseCarbon dioxideTranscutaneous carbon dioxide

Outcome Measures

Primary Outcomes (1)

  • Peak transcutaneous carbon dioxide (TcCO2) concentration.

    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 Outcomes (9)

  • Mean transcutaneous carbon dioxide concentration

    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

    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

    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

    After the participant has reached phase 2 post-anesthetic recovery. Estimated to be 30 minutes after procedure has finished.

  • Costs associated with oxygen delivery

    From the time between first sedative medication administration to the end of the procedure. Estimated duration of procedures is 30 minutes to 120 minutes.

  • +4 more secondary outcomes

Study Arms (2)

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.

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.

Device: Standard oxygenation

Interventions

High flow nasal oxygenDEVICE

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

High flow nasal oxygen
Standard oxygenationDEVICE

Supplemental oxygen through a facemask.

Standard oxygenation

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \. 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto General Hospital

Toronto, Ontario, Canada

Location

Related Publications (1)

  • 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.

    PMID: 33492872DERIVED

MeSH Terms

Conditions

Heart DiseasesRespiratory AspirationHypercapniaRespiratory Insufficiency

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesRespiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms, RespiratorySigns and Symptoms

Study Officials

  • Aaron Conway, RN, PhD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RBC Chair in Cardiovascular Nursing Research

Study Record Dates

First Submitted

February 25, 2019

First Posted

February 28, 2019

Study Start

August 7, 2019

Primary Completion

March 12, 2020

Study Completion

March 12, 2020

Last Updated

November 12, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
With publication of results.
Access Criteria
Available through a public repository

Locations

CA(1)