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

NCT04842253 | Terminated DMC

• 1 other identifier: 72859
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

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).

Conditions

Deep Sedation; Oxygen Therapy; Radiofrequency Ablation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Duration of hypoxemia event

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

• Cross over from oxygen therapy

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

Study Arms (2)

High flow nasal cannula

EXPERIMENTAL

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

Device: High flow nasal cannula

Low flow nasal cannula

NO INTERVENTION

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

Interventions

High flow nasal cannula DEVICE

HFNC during deep sedation undergoing radiofrequency ablation for atrial fibrillation.

Also known as: High flow nasal oxygen

High flow nasal cannula

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults undergoing an elective RFCA for atrial fibrillation in the Maastricht UMC Cardiac Catheter Labs under deep sedation administered by a clinician anesthesiology

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht UMC

Maastricht, 6229HX, Netherlands

Location

Related Publications (7)

• 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.

  PMID: 27372775 BACKGROUND

• 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.

  PMID: 19003534 BACKGROUND

• 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.

  PMID: 22024600 BACKGROUND

• 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.

  PMID: 27236824 BACKGROUND

• 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.

  PMID: 29847362 BACKGROUND

• 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.

  PMID: 33176129 BACKGROUND

• Homberg MC, Bouman EA, Linz D, van Kuijk SMJ, Joosten BA, Buhre WF. High-flow nasal cannula versus standard low-flow nasal cannula during deep sedation in patients undergoing radiofrequency atrial fibrillation catheter ablation: a single-centre randomised controlled trial. Trials. 2022 May 9;23(1):378. doi: 10.1186/s13063-022-06362-1.

  PMID: 35534903 DERIVED

Study Officials

• Esther AC Bouman, Doctor

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 13, 2021
• Study Start: January 4, 2022
• Primary Completion: November 18, 2024
• Study Completion: November 18, 2024
• Last Updated: February 20, 2025

Record last verified: 2025-02

Locations

NL (1)