Evaluation of a novel method of teaching endobronchial ultrasound: Physician- versus respiratory therapist-proctored simulation training

BACKGROUND:

Computer endobronchial ultrasound (EBUS) simulators have been demonstrated to improve trainee procedural skills before attempting to perform EBUS procedures on patients.

OBJECTIVE:

To compare EBUS performance following training with computer simulation proctored by EBUS-trained respiratory therapists versus the same simulation training proctored by an interventional respirologist.

METHODS:

The present analysis was a prospective study of respiratory medicine trainees learning EBUS. Two cohorts of trainees were evaluated using a previously validated method using simulated cases with performance metrics measured by the simulator. Group 1 underwent EBUS training by performing 15 procedures on an EBUS simulator (n=4) proctored by an interventional respirologist. Group 2 received identical training proctored by a respiratory therapist with special training in EBUS (n=10).

RESULTS:

No significant differences between group 1 and group 2 were apparent for the primary outcome measures of total procedure time (15.15±1.34 min versus 14.78±2.88 min; P=0.816), the percentage of lymph nodes successfully identified (88.8±5.4 versus 80.91±8.9; P=0.092) or the percentage of successful biopsies (100.0±0.0 versus 98.75±3.95; P=0.549). The learning curves were similar between groups, and did not show an obvious plateau after 19 simulated procedures in either group.

DISCUSSION:

Acquisition of basic EBUS technical skills can be achieved using computer EBUS simulation proctored by specially trained respiratory therapists or by an interventional respirologist. There appeared to be no significant advantage to having an interventional respirologist proctor the computer EBUS simulation.     

Evaluation of clinical endobronchial ultrasound skills following clinical versus simulation training

Background and objective: Endobronchial ultrasound with transbronchial needle aspiration (EBUS‐TBNA) is a pulmonary procedure that can be challenging to learn. This study aims to compare trainee EBUS‐TBNA performance during clinical procedures, following training with a computer EBUS‐TBNA simulator versus conventional clinical EBUS‐TBNA training. Methods: A prospective study of pulmonary trainees performing EBUS‐TBNA procedures on patients with suspected lung cancer and mediastinal adenopathy. Two cohorts of trainees were each evaluated while performing EBUS‐TBNA on two patients. Group 1 received training by performing 15 cases on an EBUS‐TBNA simulator (n = 4) and had never performed a clinical EBUS‐TBNA procedure. Group 2 received training by doing 15–25 EBUS‐TBNA procedures on patients (n = 4). Results: There was no significant difference in the primary outcome measure of total EBUS‐TBNA procedure time/number of successful aspirates between Groups 1 and 2 (3.95 (±0.93) vs 3.64 (±0.89), P = 0.51). Total learner EBUS‐TBNA procedure time in minutes (23.67 (±5.58) vs 21.81 (±5.36), P = 0.17) and percentage of successful aspirates (93.3% (±5.8%) vs 86.3% (±6.7%), P = 0.12) were not significantly different between Group 1 and Group 2. The only significant difference found between Group 1 and Group 2 was time to intubation in minutes (0.99 (±0.46) vs 0.50 (±0.42), P = 0.04). Conclusions: EBUS‐TBNA simulator use leads to rapid acquisition of clinical EBUS‐TBNA skills comparable with that obtained with conventional training methods using practice on patients, suggesting that skills learned using an EBUS‐TBNA simulator are transferable to clinical EBUS‐TBNA performance. EBUS‐TBNA simulators show promise for training, potentially minimizing the burden of procedural learning on patients.     

A randomized controlled trial evaluating airway inspection effectiveness during endobronchial ultrasound bronchoscopy

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.     

Assessment and learning curve evaluation of endobronchial ultrasound skills following simulation and clinical training

Background and objective: Endobronchial ultrasound is a revolutionary diagnostic pulmonary procedure. The use of a computer endobronchial ultrasound simulator could improve trainee procedural skills before attempting to perform procedures on patients. This study aims to compare endobronchial ultrasound performance following training with simulation versus conventional training using patients. Methods: A prospective study of pulmonary medicine and thoracic surgery trainees. Two cohorts of trainees were evaluated using simulated cases with performance metrics measured by the simulator. Group 1 received endobronchial ultrasound training by performing 15 cases on an endobronchial ultrasound simulator (n = 4). Group 2 received endobronchial ultrasound training by doing 15–25 cases on patients (n = 9). Results: Total procedure time was significantly shorter in group 1 than group 2 (15.15 (±1.34) vs 20.00 (±3.25) min, P < 0.05). The percentage of lymph nodes successfully identified was significantly better in group 1 than group 2 (89.8 (±5.4) vs 68.1 (±5.2), P < 0.05). There was no difference between group 1 and group 2 in the percentage of successful biopsies (100.0 (±0.0) vs 90.4 (±11.5), P = 0.13). The learning curves for simulation trained fellows did not show an obvious plateau after 19 simulated cases. Conclusions: Using an endobronchial ultrasound simulator leads to more rapid acquisition of skill in endobronchial ultrasound compared with conventional training methods, as assessed by an endobronchial ultrasound simulator. Endobronchial ultrasound simulators show promise for training with the advantage of minimizing the burden of procedural learning on patients.     

Comparative effectiveness of radial probe endobronchial ultrasound versus CT-guided needle biopsy for evaluation of peripheral pulmonary lesions: a randomized pragmatic trial

In many patients the optimal method of investigation of peripheral pulmonary lesions (PPL) is not clear. We performed a prospective randomized pragmatic trial to determine the comparative effectiveness of endobronchial ultrasound-guided transbronchial lung biopsy (EBUS-TBLB) and CT-guided percutaneous needle biopsy (CT-PNB) for the investigation of PPL. Overall complication rates were higher in those undergoing CT-PNB (27% v 3%, p = 0.03), while diagnostic accuracy of EBUS-TBLB was shown to be non-inferior to that of CT-PNB.Expected diagnostic accuracy and complication rates are likely to differ for individual patients on the basis of specific complex clinicoradiologic factors, which will influence the cost-benefit analysis between EBUS-TBLB and CT-PNB for individual patients. Further studies are required to examine the effect of these factors on clinical decision-making.     

Prospective randomised trial of endobronchial ultrasound-guide sheath versus computed tomography-guided percutaneous core biopsies for peripheral lung lesions

Aim: To determine diagnostic rate, complications and patient tolerability of endobronchial ultrasound‐guide sheath (EBUS‐GS) and computed tomography (CT)‐guided percutaneous core biopsy for peripheral lung lesions. Methods: Lesions >1 cm diameter on CT were randomised to either EBUS‐GS or CT‐guided biopsy. Excluded were patients with severe chronic obstructive airway disease, lesions touching visceral pleura or hilum, and patients with symptoms needing bronchoscopic evaluation. Patients completed preprocedure and postprocedure questionnaires on tolerability. Results: Of 64 participants (mean lesion size 29 ± 16 mm), 57 completed the study. Diagnostic sensitivity was 67% for EBUS‐GS and 78% for CT‐guided biopsy (P= not significant). In those with negative results, in the EBUS group, nine had a CT‐guided biopsy as a cross‐over, seven of which were positive. In the CT group, four had cross‐over EBUS‐GS of which three were diagnostic. Sensitivity for malignancy was 17/23 for EBUS‐GS (74%) and 23/26 (88%, P= not significant). For lesions <2 cm, CT‐guided biopsy had a significantly better diagnostic yield (80% vs 50%, P= 0.05). In EBUS‐GS cases, for lesions with an air bronchogram, sensitivity was 89%. Pneumothorax and intercostal catheter insertion occurred in three and two cases, respectively, for EBUS, and 10 and 3 cases for CT‐guided biopsy (P= 0.02 for pneumothorax). Nine unexpected admissions occurred after CT‐guided biopsy compared with three after EBUS‐GS. Overall, tolerability was high for both groups; however three patients had moderate‐to‐severe pain after CT‐guided biopsy. Conclusions: In lesions <2 cm, CT‐guided biopsy had higher yields; however, EBUS‐GS had better tolerability and fewer complications.     

Radial endobronchial ultrasound for the diagnosis of peripheral pulmonary lesions: A systematic review and meta‐analysis

Tissue diagnosis of peripheral pulmonary lesions (PPLs) can be challenging. In the past, flexible bronchoscopy was commonly performed for this purpose but its diagnostic yield is suboptimal. This has led to the development of new bronchoscopic modalities such as radial endobronchial ultrasound (R‐EBUS), electromagnetic navigation bronchoscopy (ENB) and virtual bronchoscopy (VB). We performed this meta‐analysis using data from previously published R‐EBUS studies, to determine its diagnostic yield and other performance characteristics. Ovid MEDLINE and PubMed databases were searched for R‐EBUS studies in September 2016. Diagnostic yield was calculated by dividing the number of successful diagnoses by the total number of lesions. Meta‐analysis was performed using MedCalc (Version 16.8). Inverse variance weighting was used to aggregate diagnostic yield proportions across studies. Publication bias was assessed using funnel plot and Duval and Tweedie's test. 57 studies with a total of 7872 lesions were included in the meta‐analysis. These were published between October 2002 and August 2016. Overall weighted diagnostic yield for R‐EBUS was 70.6% (95% CI: 68–73.1%). The diagnostic yield was significantly higher for lesions >2 cm in size, malignant in nature and those associated with a bronchus sign on computerized tomography (CT) scan. Diagnostic yield was also higher when R‐EBUS probe was within the lesion as opposed to being adjacent to it. Overall complication rate was 2.8%. This is the largest meta‐analysis performed to date, assessing the performance of R‐EBUS for diagnosing PPLs. R‐EBUS has a high diagnostic yield (70.6%) with a very low complication rate.     

Electromagnetic Navigation Bronchoscopy Versus Radial Endobronchial Ultrasound for Diagnosing Lung Cancer: A Propensity Score-Matched Analysis

IntroductionElectromagnetic navigation bronchoscopy (ENB) and radial endobronchial ultrasound (R-EBUS) are advanced imaging-guided bronchoscopy techniques for diagnosing pulmonary lesions. This study aimed to determine the comparative diagnostic yield of sole ENB and R-EBUS under moderate sedation.MethodsWe investigated 288 patients who underwent sole ENB (n = 157) or sole R-EBUS (n = 131) under moderate sedation for pulmonary lesion biopsy between January 2017 and April 2022. After a 1:1 propensity score-matching to control for pre-procedural factors, the diagnostic yield, sensitivity for malignancy, and procedure-related complications between both techniques were compared.ResultsThe matching resulted in 105 pairs/procedure for analyses with balanced clinical and radiological characteristics. The overall diagnostic yield was significantly higher for ENB than for R-EBUS (83.8% vs. 70.5%, p = 0.021). ENB demonstrated a significantly higher diagnostic yield than R-EBUS among those with lesions > 20 mm in size (85.2% vs. 72.3%, p = 0.034), radiologically solid lesions (86.7% vs. 72.7%, p = 0.015), and lesions with a class 2 bronchus sign (91.2% vs. 72.3%, p = 0.002), respectively. The sensitivity for malignancy was also higher for ENB than for R-EBUS (81.3% vs. 55.1%, p < 0.001). After adjusting for clinical/radiological factors in the unmatched cohort, using ENB over R-EBUS was significantly associated with a higher diagnostic yield (odd ratio = 3.45, 95% confidence interval = 1.75–6.82). Complication rates for pneumothorax did not significantly differ between ENB and R-EBUS.ConclusionENB demonstrated a higher diagnostic yield than R-EBUS under moderate sedation for diagnosing pulmonary lesions, with similar and generally low complication rates. Our data indicate the superiority of ENB over R-EBUS in a least-invasive setting.     

The compactEASIE is a feasible training model for endoscopic novices: A prospective randomised trial

BACKGROUND: The objective benefit of a training using the compact Erlangen Active Simulator for Interventional Endoscopy-simulator was demonstrated in two prospective educational trials (New York, France). The present study analysed whether endoscopic novices are able to reach a comparable level of endoscopic skills as in the above-described projects. METHODS: Twenty-seven endoscopic novices (medical students, first year residents) were enrolled in this prospective, randomised trial. The compact Erlangen Active Simulator for Interventional Endoscopy-simulator with an upper GI-organ package and blood perfusion system was used as a training tool. Basic evaluation of endoscopic skills was performed after a practical and theoretical course in diagnostic upper GI endoscopy followed by a stratified randomisation according to the rating in endoscopic skills into intensive (n=14) and control group (n=13). The intensive group was trained 12 times every second week over 7 months in 4 endoscopic disciplines (manual skills, injection therapy, haemoclip, band ligation) by skilled endoscopist (three trainees/simulator). Assessment was performed (single steps/overall) using an analogue scale from 1 to 10 (1=worst, 10=optimal performance) by expert tutors. The control group was not trained. Blinded final evaluation of all participants was performed in January 2003. RESULTS: We observed in all techniques applied a significant improvement of endoscopic skills and of the performance time in the intensive group compared to the control group (p<0.001). The comparison with the previous projects showed that the intensively trained novices achieved comparable levels of performance to the GI fellows in the New York and France Project (at least 80% of the median score in three out of four techniques). CONCLUSION: Endoscopic novices acquired notable skills in interventional endoscopy in the simulator by an intensive, periodical training using the compactEASIE.     

Pentoxifyline versus prednisolone for severe alcoholic hepatitis: A randomized controlled trial

AIM: To compare the efficacy of pentoxifylline and prednisolone in the treatment of severe alcoholic hepatitis, and to evaluate the role of different liver function scores in predicting prognosis. METHODS: Sixty-eight patients with severe alcoholic hepatitis (Maddrey score ≥ 32) received pentoxifylline ( n = 34, group Ⅰ) or prednisolone ( n = 34, group Ⅱ) for 28 d in a randomized double-blind controlled study, and subsequently in an open study (with a tapering dose of prednisolone) for a total of 3 mo, and were followed up over a period of 12 mo. RESULTS: Twelve patients in group Ⅱ died at the end of 3 mo in contrast to five patients in group Ⅰ. The probability of dying at the end of 3 mo was higher in group Ⅱ as compared to group Ⅰ (35.29% vs 14.71%, P = 0.04; log rank test). Six patients in group Ⅱ developed hepatorenal syndrome as compared to none in group Ⅰ. Pentoxifylline was associated with a significantly lower model for end-stage liver disease (MELD) score at the end of 28 d of therapy (15.53 Maddrey score was associated with increased mortality. CONCLUSION: Reduced mortality, improved risk-benefit profile and renoprotective effects of pentoxifylline compared with prednisolone suggest that pentoxifylline is superior to prednisolone for treatment of severe alcoholic hepatitis.     

Pentoxifylline versus prednisolone for severe alcoholic hepatitis: A randomized controlled trial

AIM： To compare the efficacy of pentoxifylline and prednisolone in the treatment of severe alcoholic hepatitis, and to evaluate the role of different liver function scores in predicting prognosis.
METHODS： Sixty-eight patients with severe alcoholic hepatitis （Maddrey score ≥ 32） received pentoxifylline （n = 34, group Ⅰ） or prednisolone （n = 34, group Ⅱ） for 28 d in a randomized double-blind controlled study, and subsequently in an open study （with a tapering dose of prednisolone） for a total of 3 mo, and were followed up over a period of 12 mo.
RESULTS： Twelve patients in group Ⅱ died at the end of 3 mo in contrast to five patients in group Ⅰ. The probability of dying at the end of 3 mo was higher in group Ⅱ as compared to group Ⅰ （35.29% vs 14.71%, P = 0.04; log rank test）. Six patients in group I developed hepatorenal syndrome as compared to none in group Ⅰ. Pentoxifylline was associated with a significantly lower model for end-stage liver disease （MELD） score at the end of 28 d of therapy （15.53± 3.63 vs 17.78± 4.56, P=0.04）. Higher baseline Maddrey score was associated with increased mortality.
CONCLUSION： Reduced mortality, improved risk-benefit profile and renoprotective effects of pentoxifylline compared with prednisolone suggest that pentoxifylline is superior to prednisolone for treatment of severe alcoholic hepatitis.     

Ultrasound guidance versus anatomical landmark approach for femoral artery access in coronary angiography: A randomized controlled trial and a meta‐analysis

Objectives

The objective was to assess the effect of ultrasound (US)‐guidance compared to the anatomical landmark (AL) approach in patients requiring femoral artery (FA) access for coronary angiography/percutaneous coronary interventions (PCI).

Background

US‐guidance has been proposed as a strategy to optimize FA access, potentially leading to decreased vascular complications.

Methods

Patients requiring FA access for coronary angiography/PCI were randomized to the US‐guided or AL approaches. The primary endpoint was a composite of immediate procedural vascular outcomes, and access‐site outcomes at day one. Results were subsequently pooled in a study‐level meta‐analysis of randomized trials comparing US‐guided FA access to another strategy.

Results

A total of 129 patients were randomized (64 US‐guided group; 65 AL group). The primary endpoint occurred in 30 patients (47%) with US, and in 39 patients (62%) with AL (P = 0.09). Four additional studies met the inclusion criteria and were included in the meta‐analysis (1553 patients). Following data pooling, bleeding events (OR = 0.41; 95%CI 0.20‐0.83; P = 0.01), venipunctures (OR = 0.18; 95%CI: 0.11‐0.29; P < 0.0001), and multiple puncture attempts (OR = 0.24; 95%CI: 0.19‐0.31; P < 0.0001) were significantly improved with US‐guidance, but not successful common FA cannulation (OR = 0.84; 95%CI: 0.60‐1.17; P = 0.29).

Conclusion

Our study did not show significant benefits for the use of US to guide arterial femoral access compared to the anatomical landmark approach, but pooled analysis of five randomized trials showed decreased rates of bleeding events and venipunctures, and improved first‐pass success. The clinical impact of these findings is uncertain, and do not warrant a systematic use of US‐guidance in this clinical setting.