Comparison of Oxygen Adminstration by Nasal Cannula and High Flow Cannula During Bronchoscopy

Study Overview
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Brief Summary
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Randomized controled trial to compare oxygen desaturation during fiberoptic bronchoscopy using oxygen administered with nasal prongs and high flow nasal cannula. Drops in oxygen saturation are frequent during bronchoscopy and limit the procedure compromising patient security. The investigator's aim is to contribute to select better way of oxygen administration which could prevent desaturations during bronchoscopy in children.

Official Title
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Oxygen Administration During Bronchoscopy in Children, High Flow and Common Nasal Cannula: a Randomized Controled Trial

Conditions
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Respiratory Disease

Intervention / Treatment
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* Device: Oxygen administration with Common nasal cannula
* Device: Oxygen administration with high flow nasal cannula, device Airvo2 Fisher and Pykel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: elective flexible bronchoscopy Exclusion Criteria: admitted in Neonatal intensive care previous respiratory support: oxygen any device, non invasive or invasive ventilation patient who may benefit with continuous positive pressure during procedure

Ages Eligible for Study
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Minimum Age: 29 Days
Maximum Age: 16 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Common nasal cannula<br>Oxygen administration up to 4 liters according defined protocol | Device: Oxygen administration with Common nasal cannula<br>* Oxygen administration during elective flexible bronchoscopy in children with high flow nasal cannula with inspired oxygen fraction 1.<br>|
| Experimental: High flow nasal cannula<br>Oxygen administered with high flow nasal cannula according child weight and protocol designed for this study | Device: Oxygen administration with high flow nasal cannula, device Airvo2 Fisher and Pykel<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygen desaturation | Number of patients with Oxygen saturation under 94% during bronchoscopy | Trough study completion, an average of 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Moderate oxygen desaturations | Number of patients with Oxygen saturation < 94% and > 90 % | Trough study completion, an average of 2 years | 
| Severe oxygen desaturations | Number of patients with Oxygen saturation< 90% | Trough study completion, an average of 2 years | 
| Tachypnea | Number of patients with Breath rate more than p95 fore age for more than 30 seconds | Trough study completion, an average of 2 years | 
| Apnea | Number of patients with Breath rate 0 for more than 20 seconds or recure intervention | Trough study completion, an average of 2 years | 
| Bradycardia | Number of patients with Heart rate less than p5 forte age for more than 20 seconds | Trough study completion, an average of 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Children, Desaturations, Bronchoscopy, Oxygen, High flow oxygen