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

Maastricht University Medical Center141 enrolled

Overview

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).

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

141

Conditions

Deep Sedation Oxygen Therapy Radiofrequency Ablation

Interventions

High flow nasal cannulaDEVICE

HFNC during deep sedation undergoing radiofrequency ablation for atrial fibrillation.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Maastricht UMC

Maastricht, Netherlands

Outcomes

Primary Outcomes

Hypoxemia event

The primary outcome measure will be the lowest measured blood oxygen level during the patient's sedation.

Time frame: The outcome variable will be measured during the patient's sedation (0-4 hours).

Secondary Outcomes

Duration of hypoxemia event

The secondary outcome measure will be the duration of the lowest measured blood oxygen level during the patient's sedation.

Time frame: 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.

Time frame: 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.

Time frame: The outcome variable will be measured during the patient's sedation (0-4 hours).

Data from ClinicalTrials.gov

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