Clinical trial NCT04842253: HFNC Vs LFNC in Patients with AF Undergoing RFCA Under Deep Sedation.
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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Deep Sedation
Oxygen Therapy
Radiofrequency Ablation
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2021-04-13
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Hypoxemia event
timeFrame: The outcome variable will be measured during the patient's sedation (0-4 hours).
Secondary outcomes:
measure: Duration of hypoxemia event
timeFrame: The outcome variable will be measured during the patient's sedation (0-4 hours).
measure: Cross over from oxygen therapy
timeFrame: The outcome variable will be measured during the patient's sedation (0-4 hours).
measure: To measure the incidence of hypoxemia and desaturation (SpO2 under 90% for > 60 seconds).
timeFrame: The outcome variable will be measured during the patient's sedation (0-4 hours).
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht UMC
Study officials:
affiliation: Maastricht University Medical Center
name: Esther AC Bouman, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
citation: 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.
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.
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.
citation: 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.