Deep Sedation, Oxygen Therapy, Radiofrequency Ablation
Conditions
Brief summary
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
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).
Interventions
DEVICEHigh flow nasal cannula
HFNC during deep sedation undergoing radiofrequency ablation for atrial fibrillation.
Sponsors
Maastricht University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hypoxemia event | The outcome variable will be measured during the patient's sedation (0-4 hours). | The primary outcome measure will be the lowest measured blood oxygen level during the patient's sedation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of hypoxemia event | The outcome variable will be measured during the patient's sedation (0-4 hours). | The secondary outcome measure will be the duration of the lowest measured blood oxygen level during the patient's sedation. |
| Cross over from oxygen therapy | The outcome variable will be measured during the patient's sedation (0-4 hours). | The secondary outcome measure will be cross over from oxygen therapy during sedation yes/no. |
| To measure the incidence of hypoxemia and desaturation (SpO2 under 90% for > 60 seconds). | The outcome variable will be measured during the patient's sedation (0-4 hours). | The secondary outcome measure will be the incidence SpO2 under 90% for \> 60 seconds. |
Countries
Netherlands
Outcome results
None listed