Assessment of High Flow Nasal Cannula Oxygenation in EBUS Bronchoscopy

Not Applicable

Completed

• Conditions: Lymphadenopathy; Lung Cancer
• Interventions: Device: high flow nasal oxygen

• Registration Number: NCT03226964
• Lead Sponsor: University College Hospital Galway

Brief Summary

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

Not available

Study Timeline

• Study Start: 2016-10-01
• Study First Submitted: 2017-03-14
• Study First Submitted QC: 2017-07-20
• Study First Posted: 2017-07-24
• Status Verified: 2018-04
• Primary Completion: 2018-04-01
• Study Completion: 2018-04-01
• Last Update Submitted: 2018-04-30
• Last Update Posted: 2018-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nasal prongs	high flow nasal oxygen	-
High flow nasal oxygen	high flow nasal oxygen	(Optiflow; Fisher \& Paykel, Auckland, New Zealand)

Primary Outcome Measures

Name	Time	Method
drop in oxygen saturation during procedure	through procedure completion defined as withdrawing scope from patient's mouth, an average of 30 minutes	the difference in oxygen saturation levels between pre-treatment assessments and the lowest saturation level achieved during treatment

Secondary Outcome Measures

Name	Time	Method
change in venous CO2	1 hour after procedure	Change in venous CO2 1 hour after procedure compared to pre-procedure level
end tidal CO2 during procedure	through procedure completion defined as withdrawing scope from patient's mouth an average of 30 minutes	Measured with tip of scope at lower trachea
Patient experience measure on a visual analogue scale	up to 3 hours after procedure
endotracheal intubation during or post procedure	24 hours

Trial Locations

Locations (1)

University Hospital Galway; 🇮🇪 Galway, Ireland