HFNC vs LFNC in Patients With AF Undergoing RFCA Under Deep Sedation.
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: High flow nasal cannula Participants in the high flow nasal cannula group will receive high flow nasal cannula oxygen during deep sedation. |
Device: High flow nasal cannula
HFNC during deep sedation undergoing radiofrequency ablation for atrial fibrillation.
Other Names:
|
| No Intervention: Low flow nasal cannula Participants in the current standard of care will receive low flow nasal cannula during deep sedation. |
Outcome Measures
Primary Outcome Measures
- Hypoxemia event [The outcome variable will be measured during the patient's sedation.]
The primary outcome measure will be the lowest measured blood oxygen level during the patient's sedation.
Secondary Outcome Measures
- Duration of hypoxemia event [The outcome variable will be measured during the patient's sedation.]
The secondary outcome measure will be the duration of the lowest measured blood oxygen level during the patient's sedation.
- Cross over from oxygen therapy [The outcome variable will be measured during the patient's sedation.]
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.]
The secondary outcome measure will be the incidence SpO2 under 90% for > 60 seconds.
Eligibility Criteria
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)
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Chronic Pulmonary Obstructive Disease (COPD) gold IV and COPD gold III with frequent or recent exacerbation
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Diagnosed pulmonary or cardiac condition requiring chronic oxygen therapy
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Complete nasal obstruction
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Active nose bleeding
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Untreated pneumothorax (pre- existing)
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Recent upper airway surgery
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Recent base of skull fracture
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Expected difficult airway
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Maastricht University Medical Center
Investigators
- Principal Investigator: Wolfgang WF Buhre, Professor, Professor Maastricht University. Key domain chair: Anesthesiologie.
Study Documents (Full-Text)
None provided.More Information
Publications
- 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. Review.
- 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. Review.
- 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.
- 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.
- 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.
- 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.
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