目的:评估在CT(CT)引导下射频消融术(RFA)治疗肺部恶性肿瘤在程序镇静和镇痛(PSA)下,最低4cmH2O(CPAP+4)持续气道正压通气的安全性。
方法:这是一个前瞻性的,随机化,单盲,平行组,使用开放标签医疗设备在巴塞罗那的一所三级大学医院进行的安慰剂对照试验,西班牙。计划在PSA下接受CT引导的恶性肺部肿瘤RFA的46名年龄超过18岁的患者被随机分配接受CPAP4或改良的安慰剂CPAP(Sham-CPAP)面罩。排除标准包括RFA的禁忌症,拒绝参与,无法理解程序或忍受CPAP测试,RFA之前的肺活检,并发疾病,或先前随机分配额外的肺RFA。主要结果是报告至少一次严重不良事件(SAE)的患者百分比,来自欧洲心血管和介入放射学会(CIRSE)的并发症分类,和Clavien-Dindo并发症分类,住院,和再入院。次要结果包括不良事件(AE),呼吸参数,气道管理,以及肺消融的局部放射学疗效。
结果:CPAP+4延长住院时间(1.5±1.1vs.1.0±0个住院夜,p=0.022)并增加RFA后AE的风险(比值比(95%CI):4.250(1.234至14.637),p=0.021,气胸病例更多(n=5/22,22.7%vs.n=0/24,0%,p=0.019)。按方案分析显示,CPAP+4组中SAE和CIRSE3级并发症较多(23.5%vs.0%,p=0.036)。在氧合的有效性方面没有发现显着差异,通风,或肺消融。
结论:CPAP在PSA条件下CT引导下RFA治疗肺癌期间是不安全的,即使在最低压力设置下也是如此。
背景:临床试验。政府,ClinicalTrials.govIDNCT02117908,2014年4月11日注册,https://www.
结果:gov/study/NCT02117908关键相关性声明:本研究强调了肺癌射频消融术期间持续气道正压通气的危害,即使在最小的压力下,认为在肺介入手术中手术镇静和镇痛是不安全的。研究结果为优先考虑患者安全提供了重要的见解。
结论:之前没有关于经皮肺热消融术中CPAP安全性的随机对照试验。标准化的结果测量对于放射学研究至关重要。肺RFA期间的CPAP会增加住院时间和并发症的风险。在手术镇痛下CT引导的肺癌RFA过程中,CPAP是不安全的。
OBJECTIVE: To evaluate the safety of a minimum continuous positive airway pressure of 4 cmH2O (CPAP + 4) during computed tomography (CT)-guided radiofrequency ablation (RFA) for lung malignancies under procedural sedation and analgesia (PSA).
METHODS: This was a prospective, randomised, single-blind, parallel-group, placebo-controlled trial with an open-label medical device conducted at a single tertiary university hospital in Barcelona, Spain. Forty-six patients over 18 years of age scheduled for CT-guided RFA of a malignant pulmonary tumour under PSA were randomised to receive either CPAP + 4 or a modified mask for placebo CPAP (Sham-CPAP). Exclusion criteria included contraindications for RFA, refusal to participate, inability to understand the procedure or tolerate the CPAP test, lung biopsy just prior to RFA, intercurrent diseases, or previous randomisation for additional pulmonary RFA. Primary outcomes were the percentage of patients reporting at least one serious adverse event (SAE), classification for complications from the Cardiovascular and Interventional Radiological Society of Europe (CIRSE), and Clavien-Dindo classifications for complications, hospital stay, and readmissions. Secondary outcomes included adverse events (AEs), respiratory parameters, airway management, and the local radiological efficacy of pulmonary ablation.
RESULTS: CPAP + 4 prolonged hospital stay (1.5 ± 1.1 vs. 1.0 ± 0 inpatient nights, p = 0.022) and increased the risk of AE post-RFA (odds ratio (95% CI): 4.250 (1.234 to 14.637), p = 0.021 with more pneumothorax cases (n = 5/22, 22.7% vs. n = 0/24, 0%, p = 0.019). Per-protocol analysis revealed more SAEs and CIRSE grade 3 complications in the CPAP + 4 group (23.5% vs. 0%, p = 0.036). No significant differences were found in the effectiveness of oxygenation, ventilation, or pulmonary ablation.
CONCLUSIONS: CPAP is unsafe during CT-guided RFA for lung cancer under PSA even at the lowest pressure setting.
BACKGROUND: ClinicalTrials.Gov, ClinicalTrials.gov ID NCT02117908, Registered 11 April 2014, https://www.
RESULTS: gov/study/NCT02117908 CRITICAL RELEVANCE STATEMENT: This study highlights the hazards of continuous positive airway pressure during radiofrequency ablation of lung cancer, even at minimal pressures, deeming it unsafe under procedural sedation and analgesia in pulmonary interventional procedures. Findings provide crucial insights to prioritise patient safety.
CONCLUSIONS: No prior randomised controlled trials on CPAP safety in percutaneous lung thermo-ablation. Standardised outcome measures are crucial for radiology research. CPAP during lung RFA raises hospital stay and the risk of complications. CPAP is unsafe during CT-guided RFA of lung cancer under procedural sedoanalgesia.