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High Flow Nasal Oxygen During Sedation

NCT ID: NCT03858257

Last Updated: 2020-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-07

Study Completion Date

2020-03-12

Brief Summary

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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

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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

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Anesthesia Cardiac Disease

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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High flow nasal oxygen

The gas temperature will commence at the 'High' setting (ranges 30-32ยบ 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.

Group Type EXPERIMENTAL

High flow nasal oxygen

Intervention Type DEVICE

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.

Group Type OTHER

Standard oxygenation

Intervention Type DEVICE

Supplemental oxygen through a facemask.

Interventions

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High flow nasal oxygen

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

Intervention Type DEVICE

Standard oxygenation

Supplemental oxygen through a facemask.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Aaron Conway

RBC Chair in Cardiovascular Nursing Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aaron Conway, RN, PhD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

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Toronto General Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 33492872 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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18-6343

Identifier Type: -

Identifier Source: org_study_id