HFNC Vs LFNC in Patients with AF Undergoing RFCA Under Deep Sedation.

Maastricht University Medical Centre (MUMC)

Status: Terminated

Conditions: Oxygen Therapy; Deep Sedation; Radiofrequency Ablation

Treatments: Device: High flow nasal cannula

Study type: Interventional

Funder types: Other

Identifiers

NCT04842253

72859

Details and patient eligibility

About

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).

Full 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).

Enrollment: 141 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

141 participants in 2 patient groups

High flow nasal cannula

Experimental group

Description:

Participants in the high flow nasal cannula group will receive high flow nasal cannula oxygen during deep sedation.

Treatment:

Device: High flow nasal cannula

Low flow nasal cannula

No Intervention group

Description:

Participants in the current standard of care will receive low flow nasal cannula during deep sedation.