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BACKGROUND: The difference in patient comfort with conscious sedation versus general anaesthesia for bronchoscopy has not been adequately assessed in a randomised trial. This study aimed to assess if patient comfort during bronchoscopy with conscious sedation is noninferior to general anaesthesia. METHODS: 96 subjects were randomised to receive conscious sedation or general anaesthesia for bronchoscopy. The primary outcome was subject comfort. Secondary outcomes included willingness to undergo a repeat procedure if necessary and level of sedation assessed clinically and by bispectral index (BIS) monitoring. RESULTS: There was no significant difference between subject comfort scores (difference -0.01, 95% CI -0.63-0.61 on a 10-point scale; p=0.97) or willingness to undergo a repeat procedure (97.7% versus 91.8%, 95% CI -4.8-15.5%; p=0.37). Deeper levels of sedation in the general anaesthesia cohort was confirmed with both clinical and BIS monitoring. There was no significant difference in diagnostic accuracy (conscious sedation 93.9%, 95% CI 80.4-98.3% versus general anaesthesia 86.5%, 95% CI 72.0-94.1%; p=0.43). There were more complications (29.6%, 95% CI 18.2-44.2% versus 6.1%, 95% CI 2.1-16.5%; p<0.01) in the general anaesthesia group. There was no relationship between high BIS scores and subject discomfort. BIS levels <40 during a procedure were associated with increased complications. CONCLUSION: Conscious sedation is not inferior to general anaesthesia in providing patient comfort during bronchoscopy, despite lighter sedation, and is associated with fewer complications and comparable diagnostic accuracy. BIS monitoring may have a role in preventing complications associated with deeper sedation.
RESUMEN
The aim of this study was to assess the reproducibility and diagnostic performance for coronary artery disease (CAD) of an automated software package, 4D-MSPECT, and compare the results with a visual approach. We enrolled 60 patients without previously known CAD, who underwent dual-isotope rest Tl-201/stress Tc-99m sestamibi myocardial perfusion imaging and subsequent coronary angiography within 3 months. The automated summed stress score (A-SSS), summed rest score (A-SRS) and summed difference score (A-SDS) were obtained using a 17-segment five-point scale model with 4D-MSPECT. For intraobserver and interobserver variability assessment, automated scoring was done by a nuclear medicine physician twice and by a nuclear medicine technologist. The visual summed stress score (V-SSS), summed rest score (V-SRS), and summed difference score (V-SDS) were obtained by consensus of two nuclear medicine physicians. The intraobserver and interobserver agreements of automated segmental scores were excellent. The intraobserver and interobserver summed scores also correlated well. Agreements between visual and automated segmental scores were moderate (weighted kappa of 0.55 and 0.50 for stress and rest images, respectively). Correlations between automated and visual summed scores were high, with correlation coefficients of 0.89, 0.85 and 0.82 for SSS, SRS and SDS, respectively (all p < 0.001). The receiver operating characteristic area under the curve for diagnosis of CAD by V-SSS, V-SDS, A-SSS and A-SDS were 0.78 +/- 0.06, 0.87 +/- 0.05, 0.84 +/- 0.05 and 0.90 +/- 0.04, respectively. A-SDS had better diagnostic performance than A-SSS and V-SSS (p = 0.043 and p = 0.032, respectively), whereas there was no statistically significant difference between A-SDS and V-SDS (p = 0.56). Using V-SDS > or = 2 as a diagnostic threshold, the sensitivity, specificity, and accuracy for CAD were 83.7%, 76.5% and 81.7%, respectively. Using A-SDS > or = 3 as a diagnostic threshold, the sensitivity, specificity, and accuracy for CAD were 79.1%, 82.4% and 80.0%, respectively. In conclusion, the reproducibility of automated semiquantitative analysis with 4D-MSPECT was excellent. The diagnostic performance of automated semiquantitative analysis with 4D-MSPECT was comparable with the visual approach.