Assessment of High Flow Nasal Cannula Oxygenation in EBUS Bronchoscopy

Study Overview
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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.

Official Title
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Assessment of High Flow Nasal Cannula Oxygenation in EBUS Bronchoscopy

Conditions
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Lung Cancer, Lymphadenopathy

Intervention / Treatment
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* Device: high flow nasal oxygen


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High flow nasal oxygen<br>(Optiflow; Fisher & Paykel, Auckland, New Zealand) | Device: high flow nasal oxygen<br>* humidified high flow nasal oxygen<br>|
| Active Comparator: Nasal prongs<br> | Device: high flow nasal oxygen<br>* humidified high flow nasal oxygen<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endobronchial ultrasound, high flow nasal oxygen