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1.
Clin Transplant ; 37(10): e15056, 2023 10.
Artigo em Inglês | MEDLINE | ID: mdl-37354125

RESUMO

INTRODUCTION: The safety and efficacy of indwelling pleural catheters (IPCs) in lung allograft recipients is under-reported. METHODS: We performed a multicenter, retrospective analysis between 1/1/2010 and 6/1/2022 of consecutive IPCs placed in lung transplant recipients. Outcomes included incidence of infectious and non-infectious complications and rate of auto-pleurodesis. RESULTS: Seventy-one IPCs placed in 61 lung transplant patients at eight centers were included. The most common indication for IPC placement was recurrent post-operative effusion. IPCs were placed at a median of 59 days (IQR 40-203) post-transplant and remained for 43 days (IQR 25-88). There was a total of eight (11%) complications. Infection occurred in five patients (7%); four had empyema and one had a catheter tract infection. IPCs did not cause death or critical illness in our cohort. Auto-pleurodesis leading to the removal of the IPC occurred in 63 (89%) instances. None of the patients in this cohort required subsequent surgical decortication. CONCLUSIONS: The use of IPCs in lung transplant patients was associated with an infectious complication rate comparable to other populations previously studied. A high rate of auto-pleurodesis was observed. This work suggests that IPCs may be considered for the management of recurrent pleural effusions in lung allograft recipients.


Assuntos
Derrame Pleural Maligno , Humanos , Derrame Pleural Maligno/etiologia , Estudos Retrospectivos , Transplantados , Cateteres de Demora/efeitos adversos , Pulmão
2.
Respiration ; 101(2): 166-173, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-34515222

RESUMO

BACKGROUND: Several advanced bronchoscopy platforms are currently available, but the clinical data supporting their use vary. Electromagnetic navigation bronchoscopy (ENB) remains the dominant technology; it is limited by its reliance on preoperative computed tomography, which only approximates patient anatomy during the procedure. Recently, ENB was enhanced with the (1) addition of digital tomosynthesis-based navigation correction, (2) improvements in planning algorithms, and (3) continuous real-time guidance (Illumisite™; Medtronic, Minneapolis, MN, USA). There are currently no clinical data on the diagnostic yield and safety profile of this system. OBJECTIVES: The primary objective of this study is to describe the diagnostic yield of the first 100 pulmonary parenchymal lesions sampled using the multimodality navigation bronchoscopy (MNB) platform. The secondary objective is to describe safety. METHODS: In this single-center prospective observational study, a database was maintained to track patient, procedural, and outcome data for the first 100 consecutive lesions sampled using the MNB platform at an academic quaternary referral center. Descriptive statistics and univariate and multivariate analyses are reported. RESULTS: The overall diagnostic yield of samples acquired was 79% (79/100). In the cohort where digital tomosynthesis was used, the diagnostic yield was 83% (69/83). Sensitivity for malignancy was 71% (52/73). Overall complication rates were low: pneumothorax (n = 3, 3%) and bleeding requiring intervention (n = 2, 2%). There were no procedural-related hospital admissions. CONCLUSIONS: The MNB system performed favorably. Platform superiority cannot be established without future prospective and comparative studies.


Assuntos
Neoplasias Pulmonares , Pneumotórax , Broncoscopia/métodos , Fenômenos Eletromagnéticos , Humanos , Pulmão/patologia , Neoplasias Pulmonares/patologia , Pneumotórax/etiologia , Pneumotórax/patologia
3.
Respiration ; 101(12): 1131-1138, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36265451

RESUMO

BACKGROUND: Bronchoscopic lung biopsy is typically performed using transbronchial forceps. However, this method is limited by small sample size and presence of crush artifact. Cryobiopsy offers the potential to overcome these limitations with larger artifact-free samples but has not been widely adopted due to concerns over increased rates of bleeding and pneumothorax. A new, smaller 1.1-mm cryoprobe has been developed that operates in a similar fashion to forceps, though the safety profile of this cryoprobe has not yet been prospectively studied. OBJECTIVE: The aim of this study was to investigate the safety of transbronchial biopsy using a novel 1.1-mm cryoprobe. METHODS: This prospective, single-arm study enrolled patients referred for transbronchial biopsy. All procedures were performed using the 1.1-mm cryoprobe with oversheath. The primary outcome was the composite of significant complications related to the cryobiopsy procedure (bleeding Grade ≥3, pneumothorax Grade ≥2, and respiratory failure). Bleeding and pneumothorax were graded according to previously published scales. RESULTS: Fifty participants from two academic medical centers underwent transbronchial cryobiopsy. Indications for biopsy included evaluation of lung transplant allograft (50%), diffuse lung disease (44%), and pulmonary parenchymal lesion (6%). There were two pneumothoraces (4%), neither of which required aspiration or chest tube placement. There were no Grade 3 or 4 bleeding events. Mild bleeding (Grade ≤2) was observed in 25 cases (50%). No complications occurred that met the a priori primary outcome of bleeding Grade ≥3, pneumothorax Grade ≥2, and respiratory failure. CONCLUSIONS: Transbronchial cryobiopsy using a 1.1-mm cryoprobe is feasible with an acceptable safety profile.


Assuntos
Congelamento das Extremidades , Pneumotórax , Insuficiência Respiratória , Humanos , Broncoscopia/efeitos adversos , Broncoscopia/métodos , Estudos Prospectivos , Estudos de Viabilidade , Pneumotórax/epidemiologia , Pneumotórax/etiologia , Biópsia/efeitos adversos , Biópsia/métodos , Pulmão/patologia , Hemorragia/epidemiologia , Hemorragia/etiologia , Congelamento das Extremidades/complicações , Congelamento das Extremidades/patologia
4.
Respirology ; 25(2): 206-213, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-31265204

RESUMO

BACKGROUND AND OBJECTIVE: The diagnostic yield of electromagnetic navigation bronchoscopy (ENB) is inferior to that of computed tomography (CT)-guided needle biopsy for pulmonary nodules. One explanation for this is divergence between the nodule location on the pre-procedure CT scan and its actual location during the procedure. Fluoroscopic ENB (F-ENB) consists of digital tomosynthesis using a conventional C-arm to re-register the target lesion based on near real-time imaging. We performed a retrospective review of ENB cases at our institution before and after introduction of F-ENB to assess diagnostic yield. METHODS: All consecutive ENB procedures performed at our institution from 25 December 2017 to 25 August 2018 were reviewed. F-ENB was introduced on 25 April 2018. Two cohorts were analysed: standard ENB (S-ENB) from 25 December 2017 to 24 April 2018 and F-ENB from 25 April 2018 to 25 August 2018. All procedural, demographic and diagnostic data were collected. Descriptive statistics, chi-square, Wilcoxon test and Student's t-test were used where appropriate. A multivariable regression analysis was performed to assess factors associated with diagnostic yield. RESULTS: A total of 101 and 67 nodules were biopsied in the S-ENB and F-ENB groups, respectively. Diagnostic yield was 54% in S-ENB cohort and 79% in the F-ENB group (P = 0.0019). Factors independently associated with a positive diagnosis were F-ENB and a positive radial ultrasound view (odds ratio (OR): 3.57, 95% CI: 1.56-8.18 and OR: 3.74, 95% CI: 1.37-11.05, respectively). Complications were minimal (pneumothorax: 1.5%). CONCLUSION: The use of F-ENB may increase the diagnostic yield of ENB and has a low complication rate.


Assuntos
Broncoscopia/métodos , Neoplasias Pulmonares/diagnóstico , Nódulos Pulmonares Múltiplos/diagnóstico , Idoso , Broncoscopia/efeitos adversos , Feminino , Fluoroscopia , Humanos , Biópsia Guiada por Imagem/efeitos adversos , Biópsia Guiada por Imagem/métodos , Pulmão/patologia , Neoplasias Pulmonares/patologia , Masculino , Pessoa de Meia-Idade , Nódulos Pulmonares Múltiplos/patologia , Pneumotórax/etiologia , Estudos Retrospectivos , Tomografia Computadorizada por Raios X , Ultrassonografia
5.
Am J Respir Crit Care Med ; 193(3): 273-80, 2016 Feb 01.
Artigo em Inglês | MEDLINE | ID: mdl-26426458

RESUMO

RATIONALE: Hypoxemia is common during endotracheal intubation of critically ill patients and may predispose to cardiac arrest and death. Administration of supplemental oxygen during laryngoscopy (apneic oxygenation) may prevent hypoxemia. OBJECTIVES: To determine if apneic oxygenation increases the lowest arterial oxygen saturation experienced by patients undergoing endotracheal intubation in the intensive care unit. METHODS: This was a randomized, open-label, pragmatic trial in which 150 adults undergoing endotracheal intubation in a medical intensive care unit were randomized to receive 15 L/min of 100% oxygen via high-flow nasal cannula during laryngoscopy (apneic oxygenation) or no supplemental oxygen during laryngoscopy (usual care). The primary outcome was lowest arterial oxygen saturation between induction and 2 minutes after completion of endotracheal intubation. MEASUREMENTS AND MAIN RESULTS: Median lowest arterial oxygen saturation was 92% with apneic oxygenation versus 90% with usual care (95% confidence interval for the difference, -1.6 to 7.4%; P = 0.16). There was no difference between apneic oxygenation and usual care in incidence of oxygen saturation less than 90% (44.7 vs. 47.2%; P = 0.87), oxygen saturation less than 80% (15.8 vs. 25.0%; P = 0.22), or decrease in oxygen saturation greater than 3% (53.9 vs. 55.6%; P = 0.87). Duration of mechanical ventilation, intensive care unit length of stay, and in-hospital mortality were similar between study groups. CONCLUSIONS: Apneic oxygenation does not seem to increase lowest arterial oxygen saturation during endotracheal intubation of critically ill patients compared with usual care. These findings do not support routine use of apneic oxygenation during endotracheal intubation of critically ill adults. Clinical trial registered with www.clinicaltrials.gov (NCT 02051816).


Assuntos
Estado Terminal , Intubação Intratraqueal , Laringoscopia , Oxigênio/administração & dosagem , Idoso , Artérias , Feminino , Humanos , Unidades de Terapia Intensiva , Masculino , Pessoa de Meia-Idade , Oxigênio/sangue
6.
Crit Care Med ; 44(11): 1980-1987, 2016 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-27355526

RESUMO

OBJECTIVE: To evaluate the effect of video laryngoscopy on the rate of endotracheal intubation on first laryngoscopy attempt among critically ill adults. DESIGN: A randomized, parallel-group, pragmatic trial of video compared with direct laryngoscopy for 150 adults undergoing endotracheal intubation by Pulmonary and Critical Care Medicine fellows. SETTING: Medical ICU in a tertiary, academic medical center. PATIENTS: Critically ill patients 18 years old or older. INTERVENTIONS: Patients were randomized 1:1 to video or direct laryngoscopy for the first attempt at endotracheal intubation. MEASUREMENTS AND MAIN RESULTS: Patients assigned to video (n = 74) and direct (n = 76) laryngoscopy were similar at baseline. Despite better glottic visualization with video laryngoscopy, there was no difference in the primary outcome of intubation on the first laryngoscopy attempt (video 68.9% vs direct 65.8%; p = 0.68) in unadjusted analyses or after adjustment for the operator's previous experience with the assigned device (odds ratio for video laryngoscopy on intubation on first attempt 2.02; 95% CI, 0.82-5.02, p = 0.12). Secondary outcomes of time to intubation, lowest arterial oxygen saturation, complications, and in-hospital mortality were not different between video and direct laryngoscopy. CONCLUSIONS: In critically ill adults undergoing endotracheal intubation, video laryngoscopy improves glottic visualization but does not appear to increase procedural success or decrease complications.


Assuntos
Estado Terminal , Intubação Intratraqueal/métodos , Laringoscopia/métodos , Gravação em Vídeo , Centros Médicos Acadêmicos , Idoso , Dióxido de Carbono/sangue , Feminino , Mortalidade Hospitalar , Humanos , Unidades de Terapia Intensiva , Tempo de Internação/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , Oxigênio/sangue , Estudos Prospectivos , Respiração Artificial/estatística & dados numéricos , Fatores de Tempo
11.
Chest ; 165(6): 1555-1562, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38142773

RESUMO

BACKGROUND: Diagnostic yield and accuracy endpoints have been used inconsistently in the evaluation of advanced diagnostic bronchoscopy devices and techniques, limiting between-study comparisons. In addition, diagnostic accuracy can be adjudicated only after prolonged clinical follow-up, which delays reporting on the performance of novel devices. RESEARCH QUESTION: Will a conservative diagnostic yield definition result in few false-negative initial results to closely approximate diagnostic accuracy and represent a useful outcome for future studies of diagnostic utility? METHODS: Commonly used definitions of diagnostic yield were applied to a prospective data set of consecutive peripheral pulmonary lesions sampled by navigational bronchoscopy from 2017 to 2019. All consider malignancy to be diagnostic but differ in their classification of nonmalignant biopsy findings, which were subcategorized as specific benign, nonspecific benign, or normal lung. Diagnostic yield calculations were also compared with diagnostic accuracy, defined as the proportion of biopsy specimens deemed diagnostic by each definition that were confirmed accurate through 2 years of follow-up. RESULTS: A total of 450 biopsy specimens of lesions were analyzed. The prevalence of malignancy was 60.9% (274 of 450). On initial bronchoscopy pathology, there were 227 malignant diagnoses (50.4%), with a single false positive (0.4%). Among 104 biopsy specimens with specific benign findings, only two were false negative for malignancy (1.9%). There were 119 nonspecific benign biopsy specimens, with 46 false negatives for malignancy (38.7%). The discrepancy between diagnostic yield and accuracy was 0.7% for the conservative definition, which only considered malignant or specific benign findings as diagnostic. INTERPRETATION: A conservative diagnostic yield definition excluding nonspecific benign diagnoses closely approximated diagnostic accuracy through 2 years' follow-up, with a less than 1% discrepancy. Using this conservative yield definition may allow for dissemination of reliable diagnostic utility data without protracted delays needed for follow-up data in this era of rapid technological change in advanced diagnostic bronchoscopy.


Assuntos
Broncoscopia , Neoplasias Pulmonares , Humanos , Broncoscopia/métodos , Masculino , Feminino , Neoplasias Pulmonares/patologia , Neoplasias Pulmonares/diagnóstico , Pessoa de Meia-Idade , Biópsia/métodos , Idoso , Estudos Prospectivos , Pulmão/patologia
12.
Trials ; 25(1): 66, 2024 Jan 19.
Artigo em Inglês | MEDLINE | ID: mdl-38243291

RESUMO

BACKGROUND: Robotic-assisted bronchoscopy has recently emerged as an alternative to electromagnetic navigational bronchoscopy for the evaluation of peripheral pulmonary lesions. While robotic-assisted bronchoscopy is proposed to have several advantages, such as an easier learning curve, it is unclear if it has comparable diagnostic utility as electromagnetic navigational bronchoscopy. METHODS: Robotic versus Electromagnetic bronchoscopy for pulmonary LesIon AssessmeNT (RELIANT) is an investigator-initiated, single-center, open label, noninferiority, cluster randomized controlled trial conducted in two operating rooms at Vanderbilt University Medical Center. Each operating room (OR) is assigned to either robotic-assisted or electromagnetic navigational bronchoscopy each morning, with each OR day considered one cluster. All patients undergoing diagnostic bronchoscopy for evaluation of a peripheral pulmonary lesion in one of the two operating rooms are eligible. Schedulers, patients, and proceduralists are blinded to daily group allocations until randomization is revealed for each operating room each morning. The primary endpoint is the diagnostic yield defined as the proportion of cases yielding lesional tissue. Secondary and safety endpoints include procedure duration and procedural complications. Enrolment began on March 6, 2023, and will continue until 202 clusters have been accrued, with expected enrolment of approximately 400 patients by the time of completion in March of 2024. DISCUSSION: RELIANT is a pragmatic randomized controlled trial that will compare the diagnostic yield of the two most commonly used bronchoscopic approaches for sampling peripheral pulmonary lesions. This will be the first known cluster randomized pragmatic trial in the interventional pulmonology field and the first randomized controlled trial of robotic-assisted bronchoscopy. TRIAL REGISTRATION: ClinicalTrials.gov registration (NCT05705544) on January 30, 2023.


Assuntos
Neoplasias Pulmonares , Procedimentos Cirúrgicos Robóticos , Humanos , Broncoscopia/efeitos adversos , Neoplasias Pulmonares/diagnóstico , Neoplasias Pulmonares/patologia , Procedimentos Cirúrgicos Robóticos/efeitos adversos , Procedimentos Cirúrgicos Robóticos/métodos , Pulmão/patologia , Fenômenos Eletromagnéticos
13.
J Bronchology Interv Pulmonol ; 31(1): 63-69, 2024 Jan 01.
Artigo em Inglês | MEDLINE | ID: mdl-37246305

RESUMO

BACKGROUND: Benign airway stenosis (BAS) represents a significant burden on patients, providers, and healthcare systems. Spray cryotherapy (SCT) has been proposed as an adjunctive treatment to reduce BAS recurrence. We sought to examine safety and practice variations of the latest SCT system when used for BAS. METHODS: We conducted a retrospective multicenter cohort study in seven academic institutions within the Interventional Pulmonary Outcomes Group. All patients who underwent at least one SCT session with a diagnosis of BAS at the time of procedure at these institutions were included. Demographics, procedure characteristics, and adverse events were captured through each center's procedural database and electronic health record. RESULTS: A total of 102 patients underwent 165 procedures involving SCT from 2013 to 2022. The most frequent etiology of BAS was iatrogenic (n = 36, 35%). In most cases, SCT was used prior to other standard BAS interventions (n = 125; 75%). The most frequent SCT actuation time per cycle was five seconds. Pneumothorax complicated four procedures, requiring tube thoracostomy in two. Significant post-SCT hypoxemia was noted in one case, with recovery by case conclusion and no long-term effects. There were no instances of air embolism, hemodynamic compromise, or procedural or in-hospital mortality. CONCLUSION: SCT as an adjunctive treatment for BAS was associated with a low rate of complications in this retrospective multicenter cohort study. SCT-related procedural aspects varied widely in examined cases, including actuation duration, number of actuations, and timing of actuations relative to other interventions.


Assuntos
Criocirurgia , Crioterapia , Humanos , Estudos Retrospectivos , Estudos de Coortes , Constrição Patológica/etiologia , Crioterapia/efeitos adversos , Criocirurgia/efeitos adversos
14.
CHEST Pulm ; 2(1)2024 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-38737731

RESUMO

BACKGROUND: Pulmonary nodules represent a growing health care burden because of delayed diagnosis of malignant lesions and overtesting for benign processes. Clinical prediction models were developed to inform physician assessment of pretest probability of nodule malignancy but have not been validated in a high-risk cohort of nodules for which biopsy was ultimately performed. RESEARCH QUESTION: Do guideline-recommended prediction models sufficiently discriminate between benign and malignant nodules when applied to cases referred for biopsy by navigational bronchoscopy? STUDY DESIGN AND METHODS: We assembled a prospective cohort of 322 indeterminate pulmonary nodules in 282 patients referred to a tertiary medical center for diagnostic navigational bronchoscopy between 2017 and 2019. We calculated the probability of malignancy for each nodule using the Brock model, Mayo Clinic model, and Veterans Affairs (VA) model. On a subset of 168 patients who also had PET-CT scans before biopsy, we also calculated the probability of malignancy using the Herder model. The performance of the models was evaluated by calculating the area under the receiver operating characteristic curves (AUCs) for each model. RESULTS: The study cohort contained 185 malignant and 137 benign nodules (57% prevalence of malignancy). The malignant and benign cohorts were similar in terms of size, with a median longest diameter for benign and malignant nodules of 15 and 16 mm, respectively. The Brock model, Mayo Clinic model, and VA model showed similar performance in the entire cohort (Brock AUC, 0.70; 95% CI, 0.64-0.76; Mayo Clinic AUC, 0.70; 95% CI, 0.64-0.76; VA AUC, 0.67; 95% CI, 0.62-0.74). For 168 nodules with available PET-CT scans, the Herder model had an AUC of 0.77 (95% CI, 0.68-0.85). INTERPRETATION: Currently available clinical models provide insufficient discrimination between benign and malignant nodules in the common clinical scenario in which a patient is being referred for biopsy, especially when PET-CT scan information is not available.

15.
Chest ; 163(4): 977-984, 2023 04.
Artigo em Inglês | MEDLINE | ID: mdl-36441041

RESUMO

BACKGROUND: Electromagnetic navigational bronchoscopy has been the dominant bronchoscopic technology for targeting small peripheral lesions and now includes digital tomosynthesis-electromagnetic navigational bronchoscopy (DT-ENB), allowing near-real-time intraprocedural nodule visualization. Shape-sensing robotic-assisted bronchoscopy (ssRAB), with improved catheter stability and articulation recently became available. Although the diagnostic performance of these two methods seems higher than that of legacy systems, data remain limited. We sought to compare the diagnostic yield of these two novel platforms after their introduction at our institution. RESEARCH QUESTION: Does the diagnostic yield of ssRAB differ significantly from that of DT-ENB in patients undergoing biopsy of peripheral pulmonary lesions (PPLs)? STUDY DESIGN AND METHODS: This retrospective comparative cohort study analyzed prospectively collected data on consecutive procedures performed with DT-ENB and ssRAB in their first 6 months of use at our institution. Biopsies were considered diagnostic if histopathologic analysis revealed malignancy or specific benign features that readily explained the presence of a PPL. Nonspecific inflammation, normal lung or airway, and atypia not diagnostic of malignancy were considered nondiagnostic. RESULTS: SSRAB was used to biopsy 143 PPLs in 133 patients and DT-ENB was used to biopsy 197 PPLs in 170 patients. Diagnostic yield was 77% for ssRAB (110 of 143 PPLs) and 80% (158 of 197 PPLs) for DT-ENB (OR, 0.8; 95% CI, 0.5-1.4; P = .4). Median lesion diameters were 17 and 19 mm, respectively. No difference in diagnostic yield was found after adjustment for lesion size, bronchus sign, peripheral vs middle third location, and sex. Pneumothorax complicated 1.5% of ssRAB and 1.8% of DT-ENB procedures (P = .86). INTERPRETATION: SSRAB and DT-ENB showed comparable diagnostic yields and safety profiles in this comparative cohort study.


Assuntos
Neoplasias Pulmonares , Procedimentos Cirúrgicos Robóticos , Humanos , Broncoscopia , Estudos de Coortes , Estudos Retrospectivos , Fenômenos Eletromagnéticos , Neoplasias Pulmonares/diagnóstico por imagem
16.
PLoS One ; 18(10): e0290393, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37878622

RESUMO

OBJECTIVES: To evaluate the reliability of a novel segmentation-based volume rendering approach for quantification of benign central airway obstruction (BCAO). DESIGN: A retrospective single-center cohort study. SETTING: Data were ascertained using electronic health records at a tertiary academic medical center in the United States. PARTICIPANTS AND INCLUSION: Patients with airway stenosis located within the trachea on two-dimensional (2D) computed tomography (CT) imaging and documentation of suspected benign etiology were included. Four readers with varying expertise in quantifying tracheal stenosis severity were selected to manually segment each CT using a volume rendering approach with the available free tools in the medical imaging viewing software OsiriX (Bernex, Switzerland). Three expert thoracic radiologists were recruited to quantify the same CTs using traditional subjective methods on a continuous and categorical scale. OUTCOME MEASURES: The interrater reliability for continuous variables was calculated by the intraclass correlation coefficient (ICC) using a two-way mixed model with 95% confidence intervals (CI). RESULTS: Thirty-eight patients met the inclusion criteria, and fifty CT scans were selected for measurement. The most common etiology of BCAO was iatrogenic in 22 patients (58%). There was an even distribution of chest and neck CT imaging within our cohort. The average ICC across all four readers for the volume rendering approach was 0.88 (95% CI, 0.84 to 0.93), suggesting good to excellent agreement. The average ICC for thoracic radiologists for subjective methods on the continuous scale was 0.38 (95% CI, 0.20 to 0.55), suggesting poor to fair agreement. The kappa for the categorical approach was 0.26, suggesting a slight to fair agreement amongst the raters. CONCLUSION: In this retrospective cohort study, agreement was good to excellent for raters with varying expertise in airway cross-sectional imaging using a novel segmentation-based volume rendering approach to quantify BCAO. This proposed measurement outperformed our expert thoracic radiologists using conventional subjective grading methods.


Assuntos
Tomografia Computadorizada por Raios X , Humanos , Estudos Retrospectivos , Reprodutibilidade dos Testes , Estudos de Coortes , Constrição Patológica , Tomografia Computadorizada por Raios X/métodos , Variações Dependentes do Observador
17.
Res Sq ; 2023 Aug 28.
Artigo em Inglês | MEDLINE | ID: mdl-37693467

RESUMO

Background: Robotic assisted bronchoscopy has recently emerged as an alternative to electromagnetic navigational bronchoscopy for the evaluation of peripheral pulmonary lesions. While robotic assisted bronchoscopy is proposed to have several advantages, such as an easier learning curve, it is unclear if it has comparable diagnostic utility as electromagnetic navigational bronchoscopy. Methods: Robotic versus Electromagnetic Bronchoscopy for Pulmonary LesIon AssessmeNT (RELIANT) is an investigator-initiated, single-center, open label, noninferiority, cluster randomized controlled trial conducted in two operating rooms at Vanderbilt University Medical Center. Each operating room is assigned to either robotic assisted or electromagnetic navigational bronchoscopy each morning, with each OR day considered one cluster. All patients undergoing diagnostic bronchoscopy for evaluation of a peripheral pulmonary lesion in one of the two operating rooms are eligible. Schedulers, patients and proceduralists are blinded to daily group allocations until randomization is revealed for each operating room each morning. The primary endpoint is the diagnostic yield defined as the proportion of cases yielding lesional tissue. Secondary and safety endpoints include procedure duration and procedural complications. Enrolment began on March 6, 2023, and will continue until 202 clusters have been accrued, with expected enrolment of approximately 400 patients by the time of completion in March of 2024. Discussion: RELIANT is a pragmatic randomized controlled trial that will compare the diagnostic yield of the two most commonly used bronchoscopic approaches for sampling peripheral pulmonary lesions. This will be the first known cluster randomized pragmatic trial in the interventional pulmonology field and the first randomized controlled trial of robotic assisted bronchoscopy. Trial registration: ClinicalTrials.gov registration (NCT05705544) on January 30, 2023.

18.
medRxiv ; 2023 Nov 23.
Artigo em Inglês | MEDLINE | ID: mdl-38045245

RESUMO

Background: Lung nodule incidence is increasing. Many nodules require biopsy to discriminate between benign and malignant etiologies. The gold-standard for minimally invasive biopsy, computed tomography-guided transthoracic needle biopsy (CT-TTNB), has never been directly compared to navigational bronchoscopy, a modality which has recently seen rapid technological innovation and is associated with improving diagnostic yield and lower complication rate. Current estimates of the diagnostic utility of both modalities are based largely on non-comparative data with significant risk for selection, referral, and publication biases. Methods: The VERITAS trial (na V igation E ndoscopy to R each Indeterminate lung nodules versus T ransthoracic needle A spiration, a randomized controlled S tudy) is a multicenter, 1:1 randomized, parallel-group trial designed to ascertain whether electromagnetic navigational bronchoscopy with integrated digital tomosynthesis is noninferior to CT-TTNB for the diagnosis of peripheral lung nodules 10-30 mm in diameter with pre-test probability of malignancy of at least 10%. The primary endpoint is diagnostic accuracy through 12 months follow-up. Secondary endpoints include diagnostic yield, complication rate, procedure duration, need for additional invasive diagnostic procedures, and radiation exposure. Discussion: The results of this rigorously designed trial will provide high-quality data regarding the management of lung nodules, a common clinical entity which often represents the earliest and most treatable stage of lung cancer. Several design challenges are described. Notably, all nodules are centrally reviewed by an independent interventional pulmonology and radiology adjudication panel relying on pre-specified exclusions to ensure enrolled nodules are amenable to sampling by both modalities while simultaneously protecting against selection bias favoring either modality. Conservative diagnostic yield and accuracy definitions with pre-specified criteria for what non-malignant findings may be considered diagnostic were chosen to avoid inflation of estimates of diagnostic utility. Trial registration: ClinicalTrials.gov NCT04250194.

19.
Otolaryngol Head Neck Surg ; 168(6): 1570-1575, 2023 06.
Artigo em Inglês | MEDLINE | ID: mdl-36939627

RESUMO

The North American Airway Collaborative (NoAAC) previously published a 3-year multi-institutional prospective cohort study showing variation in treatment effectiveness between 3 primary surgical techniques for idiopathic subglottic stenosis (iSGS). In this report, we update these findings to include 5 years of data evaluating treatment effectiveness. Patients in the NoAAC cohort were re-enrolled for 2 additional years and followed using the prespecified published protocol. Consistent with prior data, prospective observation of 487 iSGS patients for 5 years showed treatment effectiveness differed by modality. Cricotracheal resection maintained the lowest rate of recurrent operation (5%), followed by endoscopic resection with adjuvant medical therapy (30%) and endoscopic dilation (50%). These data support the initial observations and continue to provide value to providers and patients navigating longitudinal decision-making. Level of evidence: 2-prospective cohort study.


Assuntos
Laringoestenose , Humanos , Constrição Patológica , Estudos Prospectivos , Estudos Retrospectivos , Laringoestenose/cirurgia , Resultado do Tratamento
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