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高流量鼻导管与标准低流量鼻导管在接受射频心房颤动导管消融术的患者深度镇静期间的比较:一项单中心随机对照试验。

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.

机构信息

Department of Anaesthesiology and Pain Medicine, Maastricht University Medical Centre, Maastricht, the Netherlands.

Department of cardiology, Maastricht University Medical Centre and cardiovascular research institute Maastricht, Maastricht, the Netherlands.

出版信息

Trials. 2022 May 9;23(1):378. doi: 10.1186/s13063-022-06362-1.

Abstract

BACKGROUND

To our knowledge, there are few trials studying the effect of high-flow nasal cannula (HFNC) during deep sedation. Our hypothesis is that high-flow nasal cannula (HFNC) will prevent hypoxemia and desaturation as compared to low-flow nasal cannula (LFNC) during prolonged deep sedation in patients with atrial fibrillation undergoing radiofrequency catheter ablation (RFCA).

METHODS

A single-centre, randomised controlled trial with HFNC as the intervention and LFNC as the control group. A total of 94 adult patients per group undergoing elective radiofrequency atrial fibrillation catheter ablation under deep sedation. will be included. The primary outcome is the lowest oxygen saturation (SpO). Secondary outcomes are as follows: the duration of lowest SpO, cross over from oxygen therapy in both directions, incidence of SpO below 90% > 60 seconds, adverse sedation events, adverse effects of HFNC, mean CO, peak CO and patients experience with oxygen therapy. The study will take place during the 2-day admission period for RFCA. Patients can fill out their questionnaires in the first week after treatment.

DISCUSSION

HFNC is increasingly used as a technique for oxygen delivery in procedural sedation and analgesia. We hypothesise that HFNC is superior to the standard treatment LFNC in patients under deep sedation with respect to the incidence of desaturation. To our knowledge, there are no adequately powered clinical trial studies on the effects of HFNC in prolonged deep sedation.

TRIAL REGISTRATION

ClinicalTrials.gov NCT04842253. Registered on 04 April 2021.

摘要

背景

据我们所知,很少有研究探讨高流量鼻导管(HFNC)在深度镇静期间的作用。我们的假设是,与低流量鼻导管(LFNC)相比,HFNC 在接受射频导管消融(RFCA)的心房颤动患者进行长时间深度镇静期间将预防低氧血症和饱和度下降。

方法

一项单中心、随机对照试验,以 HFNC 为干预措施,LFNC 为对照组。每组各纳入 94 名接受深度镇静下选择性射频心房颤动导管消融的成年患者。主要结局是最低血氧饱和度(SpO)。次要结局如下:最低 SpO 的持续时间、氧疗的双向交叉、SpO 低于 90%>60 秒的发生率、镇静不良事件、HFNC 的不良影响、平均 CO、峰值 CO 和患者对氧疗的体验。该研究将在 RFCA 的 2 天入院期间进行。患者可以在治疗后第一周填写问卷。

讨论

HFNC 作为程序镇静和镇痛中氧输送的技术越来越多地被使用。我们假设在深度镇静的患者中,HFNC 在饱和度下降的发生率方面优于标准治疗 LFNC。据我们所知,关于 HFNC 在长时间深度镇静中的效果,目前尚无足够效力的临床试验研究。

试验注册

ClinicalTrials.gov NCT04842253。于 2021 年 4 月 4 日注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a4a7/9082831/5290ed315fdd/13063_2022_6362_Fig1_HTML.jpg

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