Oxygen Supplementation During Bronchoscopy: High Flow Versus Low Flow Oxygen

Study Overview
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Brief Summary
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In general bronchoscopy is a safe procedure with low rate of complications. Indeed, contraindications to flexible bronchoscopy are mostly relative rather than absolute. This is the case of preexisting decreased blood oxygen levels which may be present in patients requiring further bronchopulmonary investigation. To avoid the deleterious effects of oxygen drops oxygen supplementation is recommended. The purpose of this study is to evaluate the efficiency and safety of oxygen supplementation obtained with the use of a high flow nasal cannula compared with a low flow nasal cannula during flexible bronchoscopy. Consecutive patients referred by their treating physician for bronchoscopy will be offered to take part in the study. Those who wish to participate and give their consent will be randomly assigned into one of two treatment groups (supplemental oxygen given via low flow nasal cannula or via high flow nasal cannula). Assignment to either treatment arm will not affect in any way the intended purpose of the bronchoscopy. All patients will be closely monitored during the procedure and 2 hours following its completion. Monitoring will be conducted, using strictly non-invasive measures.

Official Title
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Oxygen Supplementation During Bronchoscopy: High-Flow Nasal Cannula or Low-Flow Nasal Cannula

Conditions
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Hypoxia

Intervention / Treatment
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* Device: High flow nasal oxygen supplementation
* Device: low flow nasal oxygen supplementation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients scheduled to undergo routine bronchoscopy for diagnostic purposes Exclusion Criteria: inability to give an informed consent nasal deformities

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low flow nasal oxygen supplementation<br>Low flow nasal oxygen supplementation as per routine standard of care(control arm) | Device: low flow nasal oxygen supplementation<br>* Low-flow nasal ventilation: This will be carried out using a regular nasal cannula fed with oxygen at flow rates from 2 to 6 liters/minute.<br>|
| Experimental: High flow nasal oxygen supplementation<br>High-flow nasal ventilation: This will be carried out using the Precision Flow device (Opti-Flow, Auckland, New Zealand). This device is intended to add warm moisture to breathing gases from an external source. Flow rate via the nasal cannula will be kept at 50 Liters/min and fractional inspired oxygen concentration will be set at 0.35 | Device: High flow nasal oxygen supplementation<br>* High-flow nasal ventilation: This will be carried out using the Precision Flow device (Opti-Flow, Auckland, New Zealand). This device is intended to add warm moisture to breathing gases from an external source. Flow rate via the nasal cannula will be kept at 50 Liters/min and fractional inspired oxygen concentration will be set at 0.35.<br>* Other names: Precision Flow device (Opti-Flow, Auckland, New Zealand);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygen desaturation index 4% (ODI4%) |  | duration of bronchoscopy with an expected average duration of 30 minutes | 
| oxygen cumulative time below 88%(OCT88%) |  | beginning to end of bronchoscopy procedure with an expected average duration of 30minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of bradycardic and tachycardic events |  | beginning to end of bronchoscopy with an expected averag duration of 30 minutes | 
| change in expired end tidal carbon dioxide before and after completion of bronchoscopy |  | beginning to end of bronchoscopy with an expected average duration of 30 minutes | 
| oxygen desaturation index 4% |  | preprocedural to 2 hours post procedure with an expected total duration of 3 hours | 
| cumulative oxygen time 88% |  | pre-procedural to 2 hours post precedure with an expected total duration of 3 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bronchoscopy, hypoxia, oxygen supplementation, safety