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

Radiofrequency Ablation Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04842253
• Other study ID #: 72859
• Status: Recruiting
• Phase: N/A
• Start date: January 4, 2022
• Est. completion date: May 2025

Study information

• Verified date: April 2024
• Source: Maastricht University Medical Center
• Contact: Marloes C Homberg, MPA
• Phone: 0031-43-3876543
• Email: marloes.homberg[@]mumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: May 2025
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deep Sedation
• Oxygen Therapy
• Radiofrequency Ablation

Intervention

Device:
• High flow nasal cannula
HFNC during deep sedation undergoing radiofrequency ablation for atrial fibrillation.

Locations

Country	Name	City	State
Netherlands	Maastricht UMC	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (6)

Conway A, Sutherland J. Depth of anaesthesia monitoring during procedural sedation and analgesia: A systematic review and meta-analysis. Int J Nurs Stud. 2016 Nov;63:201-212. doi: 10.1016/j.ijnurstu.2016.05.004. Epub 2016 May 25. — View Citation

Jirapinyo P, Thompson CC. Sedation Challenges: Obesity and Sleep Apnea. Gastrointest Endosc Clin N Am. 2016 Jul;26(3):527-37. doi: 10.1016/j.giec.2016.03.001. — View Citation

Koers L, Eberl S, Cappon A, Bouwman A, Schlack W, Hermanides J, Preckel B. Safety of moderate-to-deep sedation performed by sedation practitioners: A national prospective observational study. Eur J Anaesthesiol. 2018 Sep;35(9):659-666. doi: 10.1097/EJA.0000000000000835. — View Citation

Qadeer MA, Rocio Lopez A, Dumot JA, Vargo JJ. Risk factors for hypoxemia during ambulatory gastrointestinal endoscopy in ASA I-II patients. Dig Dis Sci. 2009 May;54(5):1035-40. doi: 10.1007/s10620-008-0452-2. Epub 2008 Nov 12. — View Citation

Sago T, Watanabe K, Kawabata K, Shiiba S, Maki K, Watanabe S. A Nasal High-Flow System Prevents Upper Airway Obstruction and Hypoxia in Pediatric Dental Patients Under Intravenous Sedation. J Oral Maxillofac Surg. 2021 Mar;79(3):539-545. doi: 10.1016/j.joms.2020.10.018. Epub 2020 Oct 16. — View Citation

Salukhe TV, Willems S, Drewitz I, Steven D, Hoffmann BA, Heitmann K, Rostock T. Propofol sedation administered by cardiologists without assisted ventilation for long cardiac interventions: an assessment of 1000 consecutive patients undergoing atrial fibrillation ablation. Europace. 2012 Mar;14(3):325-30. doi: 10.1093/europace/eur328. Epub 2011 Oct 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).
Secondary	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).
Secondary	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).