1% versus 2% lignocaine for airway anesthesia in endobronchial ultrasound-guided transbronchial needle aspiration: A pilot, double-blind, randomized controlled trial.
ABSTRACT: Background and Objectives:No previous study has compared different concentrations of lignocaine for topical anesthesia during endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA). In this pilot study, we compared 1% versus 2% lignocaine for topical airway anesthesia during EBUS-TBNA. Methods:In this double-blind, randomized trial, subjects were randomized to receive either 1% or 2% lignocaine for "spray-as-you-go" administration. All received combined moderate intravenous sedation (midazolam and fentanyl). Ten percent pharyngeal lignocaine spray (two sprays) and nebulized lignocaine (2.5 ml of 4% solution) were administered to all subjects. Administration of additional lignocaine was allowed at operator's discretion. The primary endpoints were operator-rated overall procedural satisfaction and cough, each assessed on visual analog scale (VAS), while the secondary outcomes included patient-rated faces pain scale scores, cumulative lignocaine dose, number of subjects receiving lignocaine >8.2 mg/kg, doses of midazolam/fentanyl between groups, and adverse events during procedure. Results:The mean (standard deviation [SD]) VAS scores for operator-rated procedure satisfaction were 64.2 (25.6) and 68.7 (23.7) in 1% and 2% group, respectively (P = 0.35). The median (interquartile range) VAS scores for operator-rated cough were 48.4 (23.9-69.9) in 1% group and 38.7 (18.6-69.5) in 2% group (P = 0.24). The mean [SD] cumulative lignocaine received in the 2% lignocaine group (248.6 [29.1] mg) was significantly greater than in 1% lignocaine group (178.5 [14.6] mg) (P < 0.01). Conclusion:One percent lignocaine is equally efficacious as 2% lignocaine for topical anesthesia during EBUS-TBNA, at a significantly lower cumulative lignocaine dose.
Project description:Background:The role of nebulized lignocaine administration for flexible bronchoscopy is unclear. Methods:In this randomized, double-blind, placebo-controlled trial, subjects undergoing diagnostic flexible bronchoscopy were randomized to receive either nebulized lignocaine (2.5 ml of 4% lignocaine) or nebulized (2.5 ml of 0.9%) saline (placebo). All received 10% lignocaine pharyngeal spray (4 sprays) and 5-ml nasal 2% lignocaine gel. 1% lignocaine solution was used for spray-as-you-go administration in all. Co-primary outcomes were Operator-rated overall procedure satisfaction and Operator-rated cough scores on Visual Analog Scale (VAS). Secondary objectives were cumulative lignocaine dose, proportion of subjects receiving >8.2-mg/kg lignocaine, and complications between the groups. Results:Two hundred and twenty subjects were randomized and 217 (109 - nebulized lignocaine and 108 - placebo) received the intervention. Baseline characteristics were comparable. Operator-rated overall procedure satisfaction scores on VAS (7.30 ± 1.54 nebulized lignocaine and 7.50 ± 1.31 placebo group,P = 0.85) and Operator-rated cough scores on VAS (3 [2-5] nebulized lignocaine and 3 [2-4] placebo group,P = 0.18) were similar. Cumulative lignocaine dose was significantly greater in nebulized lignocaine group (331.46 ± 9.41 mg vs. 232.22 ± 12.77 mg,P < 0.001), and a significantly greater number of subjects in this group received lignocaine dose >8.2 mg/kg. Minor complications occurred in 6 and 9 subjects in nebulized lignocaine and placebo groups, respectively,P = 0.41. Conclusion:Administration of nebulized lignocaine in addition to pharyngeal lignocaine spray, during no-sedation bronchoscopy, increases the cumulative lignocaine dose without improved procedural comfort. Additional nebulized lignocaine during bronchoscopy is not recommended.
Project description:BACKGROUND:Different anesthetic protocols may influence endobronchial ultrasound-guided needle aspiration (EBUS-TBNA) outcomes, patient comfort, and even safety. In this study, two anesthesia techniques were assessed and compared for EBUS-TBNA. METHODS:A prospective, multicenter study was carried out. Patients were allocated to Group 1 (general anesthesia with neuromuscular blockade and controlled ventilation) and Group 2 (intravenous sedation). EBUS-TBNA accuracy was the primary outcome. Safety, patient comfort and satisfaction, and operators' difficulties were defined as secondary outcomes. RESULTS:Of the 115 patients enrolled (Group 1 = 59, Group 2 = 56), EBUS-TBNA was performed for hilar or mediastinal lesion diagnosis and lung cancer staging in, respectively, 77 (67%) and 38 (33%) patients. The numbers of lymph nodes stations (1.8 ± 1.0 vs. 1.7 ± 1.0, p = 0.472) and punctures per station (6.9 ± 3.1 vs. 6.0 ± 2.5, p = 0.084) were similar between groups. Adequate samples were obtained from 109 patients (97.3%) with similar diagnostic accuracy. Procedure duration was not significantly different (p = 0.348). Hemodynamic parameters and systolic and diastolic blood pressures were higher in Group 1 at the beginning and at the end of the procedure. Adverse events were equally distributed, and no significant differences were found regarding patient satisfaction and bronchoscopist/anesthesiologist difficulties. CONCLUSIONS:The type of anesthesia used did not influence EBUS-TBNA outcomes. EBUS-TBNA performed under sedation or general anesthesia did not affect the diagnostic yield, complication rate, and patients' comfort and satisfaction.
Project description:This two-step study evaluated the cost-effectiveness of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) for presurgery staging of non-small cell lung cancer (NSCLC) in France (EVIEPEB; ClinicalTrial.gov identifier NCT00960271). Step 1 consisted of a high-benchmark EBUS-TBNA-training program in participating hospital centers. Step 2 was a prospective, national, multicenter study on patients with confirmed or suspected NSCLC and an indication for mediastinal staging with at least one lymph node > 1 cm in diameter. Patients with negative or uninformative EBUS-TBNA and positron-emission tomography-positive or -negative nodes, respectively, underwent either mediastinoscopy or surgery. Direct costs related to final diagnosis of node status were prospectively recorded. Sixteen of 22 participating centers were certified by the EBUS-TBNA-training program and enrolled 163 patients in Step 2. EBUS-TBNA was informative for 149 (91%) patients (75 malignant, 74 non-malignant) and uninformative for 14 (9%). Mediastinoscopy was avoided for 80% of the patients. With a 52% malignant-node rate, EBUS-TBNA positive- and negative-predictive values, respectively, were 100% and 90%. EBUS-TBNA was cost-effective, with expected savings of €1,450 per patient, and would have remained cost-effective even if all EBUS-TBNAs had been performed under general anesthesia or the cost of the procedure had been 30% higher (expected cost-saving of €994 and €1,427 per patient, respectively). After EBUS-TBNA training and certification of participating centers, the results of this prospective multicenter study confirmed EBUS-TBNA cost-effectiveness for NSCLC staging.
Project description:Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is becoming the preferred method of mediastinal staging for lung cancer. We investigated the learning curve for EBUS-TBNA using risk-adjusted cumulative sum (Cusum).A retrospective study of EBUS-TBNA was performed at a single academic institution for patients with mediastinal or hilar lymphadenopathy in the setting of proven or suspected lung cancer. A sampling pass was defined as a full retraction and repositioning of the aspiration needle. Rapid on-site evaluation was not available. To track proficiency, risk-adjusted Cusum analysis was performed using acceptable and unacceptable failure rates of 10% and 20%, respectively. Failure was defined as false negative or nondiagnostic results.During the study period, 231 patients underwent EBUS-TBNA. Prevalence of mediastinal or hilar malignancy was 66.7% (154 out of 231). Sensitivity was 92.2% (142 out of 154), and negative predictive value was 87.9% (58 out of 66). Node size was identified as a significant predictor of EBUS-TBNA success by multiple regression. Risk-adjusted Cusum analysis demonstrated that the first and only unacceptable decision interval was crossed at 22 cases. Individual practitioner learning curves were highly variable, and the operator with the highest volume was the most consistently proficient.In our experience, attainment of an acceptable failure rate for EBUS-TBNA required 22 cases. Node size is a predictor of EBUS-TBNA success. Risk-adjusted Cusum proved a powerful evaluative tool to monitor the training process of this new procedure.
Project description:Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is a minimally invasive diagnostic for mediastinal and hilar lymphadenopathy/mass. This study investigated fever incidence and associated risk factors after EBUS-TBNA in 6336 patients who underwent EBUS-TBNA at Asan Medical Center from October 2008 to February 2018. Bronchoscopists evaluated participants' medical records for fever the 24 h following EBUS-TBNA. Patients were placed in either a Fever group (n = 665) or a non-Fever group (n = 5671). Fever developed in 665 of 6336 patients (10.5%) with a mean peak body temperature of 38.3 °C (range, 37.8-40.6 °C). Multivariate analysis revealed that fever-associated risk factors after EBUS-TBNA are older age (adjusted OR 0.015, 95% CI (0.969-0.997), p = 0.015), bronchoscopic washing (adjusted OR 1.624, 95% CI (1.114-2.368), p = 0.012), more than four samples of EBUS-TBNA (adjusted OR 2.472, 95% CI (1.288-4.745), p = 0.007), hemoglobin levels before EBUS-TBNA (adjusted OR 0.876, 95% CI (0.822-0.933), p < 0.001), CRP levels before EBUS-TBNA (adjusted OR 1.115, 95% CI (1.075-1.157), p < 0.001), and a diagnosis of EBUS-TBNA tuberculosis (adjusted OR 3.409, 95% CI (1.870-6.217), p < 0.001). Clinicians should be aware of the possibility of fever after EBUS-TBNA because it is common. Additional, prospective, large-scale research should assess the need for prophylactic antibiotics for EBUS-TBNA.
Project description:RATIONALE:Patients with isolated mediastinal lymphadenopathy (IML) are a common presentation to physicians, and mediastinoscopy is traditionally considered the "gold standard" investigation when a pathological diagnosis is required. Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is established as an alternative to mediastinoscopy in patients with lung cancer. OBJECTIVE:To determine the efficacy and health care costs of EBUS-TBNA as an alternative initial investigation to mediastinoscopy in patients with isolated IML. METHODS:Prospective multicenter single-arm clinical trial of 77 consecutive patients with IML from 5 centers between April 2009 and March 2011. All patients underwent EBUS-TBNA. If EBUS-TBNA did not provide a diagnosis, then participants underwent mediastinoscopy. MEASUREMENTS AND MAIN RESULTS:EBUS-TBNA prevented 87% of mediastinoscopies (95% confidence interval [CI], 77-94%; P < 0.001) but failed to provide a diagnosis in 10 patients (13%), all of whom underwent mediastinoscopy. The sensitivity and negative predictive value of EBUS-TBNA in patients with IML were 92% (95% CI, 83-95%) and 40% (95% CI, 12-74%), respectively. One patient developed a lower respiratory tract infection after EBUS-TBNA, requiring inpatient admission. The cost of the EBUS-TBNA procedure per patient was £1,382 ($2,190). The mean cost of the EBUS-TBNA strategy was £1,892 ($2,998) per patient, whereas a strategy of mediastinoscopy alone was significantly more costly at £3,228 ($5,115) per patient (P < 0.001). The EBUS-TBNA strategy is less costly than mediastinoscopy if the cost per EBUS-TBNA procedure is less than £2,718 ($4,307) per patient. CONCLUSIONS:EBUS-TBNA is a safe, highly sensitive, and cost-saving initial investigation in patients with IML. Clinical trial registered with ClinicalTrials.gov (NCT00932854).
Project description:In the era of endobronchial/esophageal ultrasound (EBUS-TBNA/EUS-FNA), many centers forgo conventional transbronchial needle aspiration (C-TBNA) in favour of EBUS-TBNA/EUS-FNA despite no conclusive evidence showing better yields with EBUS-TBNA/EUS-FNA.Assess the feasibility of an algorithmic approach for mediastinal sampling beginning with C-TBNA utilizing rapid onsite cytologic evaluation.Descriptive analysis of 92 consecutive patients referred for adenopathy that underwent C-TBNA and subsequent EBUS-TBNA/EUS-FNA if C-TBNA was negative or nondiagnostic.92 procedures were analyzed. In 50 (54.3%) of cases, C-TBNA alone was sufficient. EBUS-TBNA was performed after C-TBNA in 27 (29.3%) of cases and EUS-FNA in 33 (35.9%) of cases. The yield was 92.9% for C-TBNA, 92.5% for EBUS-TBNA, and 89.7% for EUS-FNA. There were no statistically significant differences in yields by LN station (P = 0.51), the relationship between yield and LN size (P = 0.37), or time difference in procedures following the algorithm compared to EBUS/EUS only procedures (33.7 minutes versus 32.4 minutes on average [95% CI for difference: -9.1 to 11.7], P = 0.80).An algorithmic approach to assess the mediastinum using C-TBNA initially is feasible without sacrificing yield or procedure times. C-TBNA was sufficient for diagnosis in 54.3% of cases and can be efficiently taught in an IP training program.
Project description:Background: EBUS-TBNA is an integral tool in the diagnosis and staging of lung cancer and other diseases involving mediastinal lymphadenopathy. Most studies attesting to the performance of EBUS-TBNA are prospective analyses performed under strict protocols. The objective of our study was to compare the accuracy of EBUS-TBNA to surgery in diagnosing hilar and mediastinal pathologies in a tertiary hospital, staffed by pulmonologists with and without formal interventional pulmonary training. Methods: We retrospectively analyzed subjects who underwent EBUS-TBNA followed by a confirmatory surgical procedure from January 2012 to December 2018. The primary outcome was to evaluate the accuracy of EBUS-TBNA in the diagnosis of all mediastinal disease. Secondary analyses determined the accuracy of EBUS-TBNA in cancer, NSCLC, and non-malignant lesions individually. Results: One hundred and forty-three subjects had an EBUS-TBNA procedure followed by surgery. EBUS-TBNA for all pathologies had an accuracy of 81.2% (CI 95% 73.8-87.4) and sensitivity of 55.1% (CI 95% 41.5-68.3). The accuracy and sensitivity of individual groups were: cancer (81.7, 48.8%), NSCLC (84, 48.3%), and non-malignancy (78.9, 60%). The NSCLC group had 15 false negatives and 5 (33.3%) of them were due to non-sampling of EBUS accessible nodes. Missed sampling led to a change in the final staging in 8.6% of NSCLC subjects. Conclusion: The accuracy of EBUS-TBNA across all groups was comparable to those reported previously. However, the sensitivity was comparatively lower. This was primarily due to the large number of EBUS-TBNA accessible lymph nodes that were not sampled. This data highlights the need for guidelines outlining the best sampling approach and lymph node selection.
Project description:BACKGROUND:Endobronchial ultrasound transbronchial needle aspiration (EBUS-TBNA) has revolutionized the evaluation of patients with mediastinal and hilar adenopathy. Limitations of conventional endobronchial ultrasound (C-EBUS) bronchoscopes include the inability to perform a complete airway inspection, low definition optics, and limited maneuverability. These limitations require the use of a standard bronchoscope to perform an airway examination prior to the EBUS procedure. Recently, a hybrid endobronchial ultrasound (H-EBUS) bronchoscope with high definition optics and increased maneuverability has been introduced. Our objective was to assess the ability of H-EBUS to perform a full airway inspection and TBNA. METHODS:Patients referred for EBUS-TBNA were prospectively randomized to either form of EBUS from November 2013 to January 2014. The primary outcome was the airway segment visualization in each lobe using an EBUS bronchoscope. Secondary outcomes included the number of bronchoscopes used per procedure, procedure length, diagnostic yield and specimen adequacy. RESULTS:Sixty-two consecutive patients undergoing EBUS-TBNA were randomized to H-EBUS (n=30) or C-EBUS (n=32). In cases in which EBUS-TBNA was the only procedure performed (n=32), use of a second bronchoscope to perform an adequate airway inspection was significantly higher in C-EBUS compared to H-EBUS (5 vs. 0, P=0.046). There was better segmental visualization achieved in multiple lobes when using H-EBUS (P<0.01). No differences in TBNA sample diagnostic yield, specimen adequacy or procedure time were noted when comparing bronchoscopes (P= NS). CONCLUSIONS:Use of an H-EBUS may improve the ability to perform an adequate airway inspection potentially obviating the need for a conventional bronchoscope.
Project description:Few studies of endobronchial ultrasound-guided transbronchial needle aspiration(EBUS-TBNA) have been large enough to identify risk factors for complications. The primary objective of this study was to quantify the incidence of and risk factors for complications in patients undergoing EBUS-TBNA.Data on prospectively enrolled patients undergoing EBUS-TBNA in the American College of Chest Physicians Quality Improvement Registry, Evaluation, and Education (AQuIRE)database were extracted and analyzed for the incidence, consequences, and predictors of complications.We enrolled 1,317 patients at six hospitals. Complications occurred in 19 patients (1.44%;95% CI, 0.87%-2.24%). Transbronchial lung biopsy (TBBx) was the only risk factor for complications,which occurred in 3.21% of patients who underwent the procedure and in 1.15% of those who did not (OR, 2.85; 95% CI, 1.07-7.59; P 5 .04). Pneumothorax occurred in seven patients(0.53%; 95% CI, 0.21%-1.09%). Escalations in level of care occurred in 14 patients (1.06%;95% CI, 0.58%-1.78%); its risk factors were age . 70 years (OR, 4.06; 95% CI, 1.36-12.12; P 5 .012),inpatient status (OR, 4.93; 95% CI, 1.30-18.74; P 5 .019), and undergoing deep sedation or general anesthesia (OR, 4.68; 95% CI, 1.02-21.61; P 5 .048). TBBx was performed in only 12.6% of patients when rapid on site cytologic evaluation (ROSE ) was used and in 19.1% when it was not used ( P 5 .006).Interhospital variation in TBBx use when ROSE was used was significant ( P , .001).TBBx was the only risk factor for complications during EBUS-TBNA procedures.ROSE significantly reduced the use of TBBx.