Ventilatory Effects of THRIVE During EBUS

Study Overview
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Brief Summary
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High flow nasal cannula (HFNC) is used in interventional procedures to prevent hypoxia during sedation. In patients with a patent airway, HFNC reduces dead space ventilation as well. It is unknown if dead space ventilation is also reduced by HFNC in an EndoBroncheal UltraSound procedure, in which the airway is partially blocked by the endoscope. Especially in patients with Chronic Obstructive Pulmonary Disease (COPD) the partial blocking of the airway may reduce ventilation. If HFNC is able to reduce dead space during an EBUS-procedure, it may facilitate CO2 clearance, which may lead to a reduction in work of breathing. This study aims to investigate if HFNC reduces dead space ventilation in patients undergoing an EBUS-procedure and if this is flow-dependent. A randomized, double-blinded, cross-over study is designed.

Official Title
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Does High Flow Nasal Canula (HFNC) Prevent Hypercapnia During EBUS Under Procedural Sedation?

Conditions
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Hypercapnia, Sedation Complication, High Flow Nasal Cannula

Intervention / Treatment
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* Device: THRIVE (High Flow Nasal Cannula)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients with COPD Gold classification 3 or 4 Scheduled EBUS with sedation Exclusion Criteria: Known neurodegenerative diseases, such as Amyotrophic Lateral Sclerosis, dementia, Multiple Sclerosis or Guillain-Barré. Allergy or intolerance for propofol or esketamine Severe pulmonary hypertension (PAPsyst > 60 mmHg) Pregnancy upper airway obstruction, such as subglottic stenosis or obstructing tumors.

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: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 30 L - 70 L<br>Initially, all patients will receive 3L/min of oxygen for 10 minutes. Than, patients in this arm will receive 30L/min of High Flow Nasal Oxygen for 15 minutes and subsequently 70 L/min for another 15 minutes. | Device: THRIVE (High Flow Nasal Cannula)<br>* 2 different rates of nasal flow compared to each other and a baseline of level of nasal oxygen<br>* Other names: High Flow Nasal Oxygen;|
| Active Comparator: 70 L - 30 L<br>Initially, all patients will receive 3L/min of oxygen for 10 minutes. Than, patients in this arm will receive 70L/min of High Flow Nasal Oxygen for 15 minutes and subsequently 30 L/min for another 15 minutes. | Device: THRIVE (High Flow Nasal Cannula)<br>* 2 different rates of nasal flow compared to each other and a baseline of level of nasal oxygen<br>* Other names: High Flow Nasal Oxygen;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inspiratory CO2 at 10 minutes (baseline) | Inspiratory CO2, measured at the carinal level | at t=10 minutes | 
| Inspiratory CO2 at 25 minutes | Inspiratory CO2, measured at the carinal level | at=25 minutes | 
| Inspiratory CO2 at 45 minutes | Inspiratory CO2, measured at the carinal level | at t=45 minutes | 
| expiratory CO2 at 10 minutes (baseline) | Expiratory CO2, measured at the carinal level | at t=10 minutes | 
| expiratory CO2 at 25 minutes | Expiratory CO2, measured at the carinal level | at t=25 minutes | 
| expiratory CO2 at 45 minutes | Expiratory CO2, measured at the carinal level | t=45 minutes | 
| Slope of capnography at 10 minutes (baseline) | Angle of the D-E segment (inspiratory slope) | At t=10 minutes | 
| Slope of capnography at 25 minutes | Angle of the D-E segment (inspiratory slope) | At t=25 minutes | 
| Slope of capnography at 45 minutes | Angle of the D-E segment (inspiratory slope) | At t=45 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory rate | Respiratory rate, measured by capnography | At t=10 minutes | 
| Respiratory rate | Respiratory rate, measured by capnography | At t=25 minutes | 
| Respiratory rate | Respiratory rate, measured by capnography | At t=45 minutes | 
| The level of HFNC dead space washout | Levels of inspiratory and expiratory CO2 measured at the level of the left main bronchus, level of carina and the subglottic level. | At t=10 minutes | 
| The level of HFNC dead space washout | Levels of inspiratory and expiratory CO2 measured at the level of the left main bronchus, level of carina and the subglottic level. | At t=25 minutes | 
| The level of HFNC dead space washout | Levels of inspiratory and expiratory CO2 measured at the level of the left main bronchus, level of carina and the subglottic level. | At t=45 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High Flow Nasal Cannula, Sedation, Dead space ventilation