Safety Study of Non-invasive Ventilation Versus High-flow Oxygen in Patients With Hypoxemic Respiratory Failure Undergoing Fiberoptic Bronchoscopy.

Study Overview
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Brief Summary
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Bronchoscopy with broncho-alveolar lavage is a diagnostic tool in patients with pneumonia. Especially patients with acute or chronic pulmonary diseases are at risk of respiratory failure during or after bronchoscopy. It is known that in these cases bronchoscopy can be performed safely using non-invasive ventilation. It seems probable that high-flow oxygen, which is used in the treatment of patients with hypoxemic respiratory failure, is equally effective in preventing the development of respiratory failure during fiberoptic bronchoscopy while improving patient comfort. In this prospective randomised study the safety of high-flow oxygen is compared with non-invasive ventilation in patients with hypoxemic respiratory failure undergoing fiberoptic bronchoscopy.

Official Title
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Prospective Randomised Study on the Safety of Non-invasive Ventilation Versus High-flow Oxygen in Patients With Hypoxemic Respiratory Failure Undergoing Fiberoptic Bronchoscopy.

Conditions
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Respiratory Failure

Intervention / Treatment
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* Device: non-invasive ventilation
* Device: high-flow oxygen
* Procedure: fiberoptic bronchoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients treated in an intensive care unit indication for bronchoscopy and broncho-alveolar lavage presence of hypoxemic (SaO2/fraction of inspired oxygen(FiO2): 300 or less) and/or hypercapnic respiratory failure Exclusion Criteria: patients already on invasive ventilation indication for intubation blocked nasopharynx contraindications for non-invasive ventilation or high-flow oxygen

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 |
| --- | --- |
| Active Comparator: non-invasive ventilation<br>Performance of bronchoscopy during non-invasive ventilation. | Device: non-invasive ventilation<br>* non-invasive ventilation via face mask<br>Procedure: fiberoptic bronchoscopy<br>* fiberoptic bronchoscopy including broncho-alveolar lavage<br>|
| Experimental: high-flow oxygen<br>Performance of bronchoscopy during high-flow oxygen therapy. | Device: high-flow oxygen<br>* high-flow oxygen via nasal cannula<br>Procedure: fiberoptic bronchoscopy<br>* fiberoptic bronchoscopy including broncho-alveolar lavage<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean decrease in the saturation of oxygen (SpO2) during bronchoscopy. |  | during fiberoptic bronchoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in blood gases after the completion of fiberoptic bronchoscopy. |  | 1 hour after the completion of bronchoscopy |