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Due to changes in logistics (indications Rf and attendance PFA), it has not been feasible to include the required number of participants in this study
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High flow nasal cannula | Experimental | Participants in the high flow nasal cannula group will receive high flow nasal cannula oxygen during deep sedation. |
|
| Low flow nasal cannula | No Intervention | Participants in the current standard of care will receive low flow nasal cannula during deep sedation. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High flow nasal cannula | Device | HFNC during deep sedation undergoing radiofrequency ablation for atrial fibrillation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Cross over from oxygen therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Esther AC Bouman, Doctor | Maastricht University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht UMC | Maastricht | 6229HX | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27372775 | Background | 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. | |
| 19003534 | 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. |
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The plan to share IPD is still undecided because we are not certain if we are going to share all collected IPD or all IPD that underlie results in a publication.
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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). |
| 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). |
| 22024600 | 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. |
| 27236824 | 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. |
| 29847362 | 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. |
| 33176129 | 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. |
| 35534903 | Derived | 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. |