HFNC vs LFNC in Patients With AF Undergoing RFCA Under Deep Sedation.

Study Overview
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Brief Summary
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Oxygen supplementation through high flow nasal cannula (HFNC) may reduce the incidence of desaturation and hypoxemia during deep sedation at radiofrequency catheter ablation (RFCA procedures).This study is designed to test the hypothesis that the incidence of hypoxemia and desaturation in patients with atrial fibrillation undergoing RFCA under deep sedation, is less when using HFNC as compared to use of standard low flow nasal cannula (LFNC).

Detailed Description
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Desaturation may occur in patients under deep sedation which results in an elevated risk for perioperative adverse events including hypoxemia (1-3). The incidence of hypoxemia was 168 per 1000 in a general procedural sedation and analgesia population (4). The clinical significance of transient episodes of hypoxemia remains debatable. However, many peri-operative incidents are often short-term and limited in nature, but a number of them are a predictor to a serious complication with a permanent injury (5).This study investigates if high flow nasal cannula (HFNC) as compared to low flow nasal cannula (LFNC) will result in a lower incidence of intra-procedural oxygen desaturation and hypoxemia in patients with atrial fibrillation undergoing deep sedation for radiofrequency catheter ablation (RFCA).

Official Title
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High Flow Nasal Cannula (HFNC) Versus Standard Low Flow Nasal Cannula (LFNC) in Patients With Atrial Fibrillation Undergoing Radiofrequency Catheter Ablation (RFCA) Under Deep Desaturation.

Conditions
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Deep Sedation, Oxygen Therapy, Radiofrequency Ablation

Intervention / Treatment
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* Device: High flow nasal cannula


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults undergoing an elective RFCA for atrial fibrillation in the Maastricht UMC Cardiac Catheter Labs under deep sedation administered by a clinician anesthesiology Exclusion Criteria: Age under 18 years Body Mass Index (BMI) > 32 kg/m² Diagnosed Sleep Apnoea Syndrome (SAS) Chronic Pulmonary Obstructive Disease (COPD) gold IV and COPD gold III with frequent or recent exacerbation Diagnosed pulmonary or cardiac condition requiring chronic oxygen therapy Complete nasal obstruction Active nose bleeding Untreated pneumothorax (pre- existing) Recent upper airway surgery Recent base of skull fracture Expected difficult airway

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 cannula<br>Participants in the high flow nasal cannula group will receive high flow nasal cannula oxygen during deep sedation. | Device: High flow nasal cannula<br>* HFNC during deep sedation undergoing radiofrequency ablation for atrial fibrillation.<br>* Other names: High flow nasal oxygen;|
| No Intervention: Low flow nasal cannula<br>Participants in the current standard of care will receive low flow nasal cannula during deep sedation. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoxemia event | The primary outcome measure will be the lowest measured blood oxygen level during the patient's sedation. | The outcome variable will be measured during the patient's sedation (0-4 hours). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of hypoxemia event | The secondary outcome measure will be the duration of the lowest measured blood oxygen level during the patient's sedation. | The outcome variable will be measured during the patient's sedation (0-4 hours). | 
| Cross over from oxygen therapy | The secondary outcome measure will be cross over from oxygen therapy during sedation yes/no. | The outcome variable will be measured during the patient's sedation (0-4 hours). | 
| To measure the incidence of hypoxemia and desaturation (SpO2 under 90% for > 60 seconds). | The secondary outcome measure will be the incidence SpO2 under 90% for > 60 seconds. | The outcome variable will be measured during the patient's sedation (0-4 hours). |