Assessment of High Flow Nasal Cannula Oxygenation in EBUS Bronchoscopy

NCT ID: NCT03226964

Last Updated: 2018-05-02

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-01

Study Completion Date

2018-04-01

Brief Summary

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This study is a prospective randomised trial where a computer will randomly allocate

patients to one of two possible methods of delivering oxygen during the procedure of

bronchoscopy. This trial compares high flow nasal cannula (HFNC) with nasal prongs in

delivering oxygen to patients undergoing endo-bronchial ultrasound guided trans-

bronchial nodal aspiration (EBUS-TBNA) a specialised form of bronchoscopy procedure.

HFNC uses humidified higher gas flow rates than conventional low flow systems such as

nasal prongs which are limited by the respiratory rate and effort.

Detailed Description

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Conditions

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Lung Cancer Lymphadenopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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High flow nasal oxygen

(Optiflow; Fisher \& Paykel, Auckland, New Zealand)

Group Type EXPERIMENTAL

high flow nasal oxygen

Intervention Type DEVICE

humidified high flow nasal oxygen

Nasal prongs

Group Type ACTIVE_COMPARATOR

high flow nasal oxygen

Intervention Type DEVICE

humidified high flow nasal oxygen

Interventions

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high flow nasal oxygen

humidified high flow nasal oxygen

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subjects with a peripheral arterial pulse oximetry ≥ 90% breathing room air
* Age ≥ 18 years
* Able to breathe spontaneously throughout the procedure

Exclusion Criteria

* Respiratory or cardiac failure
* Recent myocardial infarction \< 6 weeks ago
* On long term oxygen therapy, those with tracheostomy and/ or non-invasive or invasive mechanical ventilation
* Nasal and/ or nasopharyngeal disease
* Inability to give informed consent
* Dementia
* Hepatic or end stage renal disease
* Pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University College Hospital Galway

OTHER

Sponsor Role lead

Responsible Party

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Mohammed Ahmed

Specialist Registrar in Respiratory Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Breen

Role: STUDY_CHAIR

University Hospital Galway

Locations

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University Hospital Galway

Galway, , Ireland

Site Status

Countries

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Ireland

Other Identifiers

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1.0

Identifier Type: -

Identifier Source: org_study_id

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