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

Not Applicable

Terminated

• Conditions: Oxygen Therapy; Radiofrequency Ablation; Deep Sedation
• Interventions: Device: High flow nasal cannula

• Registration Number: NCT04842253
• Lead Sponsor: Maastricht University Medical Center

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).

Study Timeline

• Study First Submitted: 2021-04-08
• Study First Submitted QC: 2021-04-08
• Study First Posted: 2021-04-13
• Study Start: 2022-01-04
• Primary Completion: 2024-11-18
• Study Completion: 2024-11-18
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-18
• Last Update Posted: 2025-02-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 141

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High flow nasal cannula	High flow nasal cannula	Participants in the high flow nasal cannula group will receive high flow nasal cannula oxygen during deep sedation.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Maastricht UMC; 🇳🇱 Maastricht, Netherlands