ABSTRACT
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. CONCLUSION: CPAP is unsafe during CT-guided RFA for lung cancer under PSA even at the lowest pressure setting. TRIAL REGISTRATION: ClinicalTrials.Gov, ClinicalTrials.gov ID NCT02117908, Registered 11 April 2014, https://www. CLINICALTRIALS: 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. KEY POINTS: 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.