GRAvity- versus Wall suction-drIven large volume Thoracentesis: a rAndomized controlled Study (GRAWITAS study).

BACKGROUND: Prior studies found no differences in procedural chest discomfort for patients undergoing manual syringe aspiration or drainage with gravity after thoracentesis. However, whether gravity drainage could protect against chest pain due to the larger negative pressure gradient generated by wall suction has not been investigated. RESEARCH QUESTION: Does wall suction drainage result in more chest discomfort compared to gravity drainage in patients undergoing large volume thoracentesis? STUDY DESIGN AND METHODS: In this multicenter, single-blinded, randomized controlled trial, patients with large free-flowing effusions of ≥500 mL were assigned to wall suction or gravity drainage in a 1:1 ratio. Wall suction was performed with suction system attached to the suction tubing and with vacuum pressure adjusted to full vacuum. Gravity drainage was performed with a drainage bag placed 100 cm below the catheter insertion site and connected via straight tubing. Patients rated chest discomfort on a 100-mm visual analog scale before, during, and after drainage. The primary outcome was postprocedural chest discomfort at 5 minutes. Secondary outcomes included measures of post procedure chest discomfort, breathlessness, procedure time, volume of fluid drained and complication rates. RESULTS: Of the 228 patients initially randomized, 221 were included in the final analysis. The primary outcome of procedural chest discomfort did not differ significantly between the groups (p = 0.08), nor did the secondary outcomes of postprocedural discomfort and dyspnea. Similar volumes were drained in both groups, but the procedure duration was longer in the gravity arm by approximately 3 minutes. No differences in rate of pneumothorax or re-expansion pulmonary edema were noted between the two groups. INTERPRETATION: Thoracentesis via wall suction and gravity drainage results in similar levels of procedural discomfort and dyspnea improvement.

Reducing hospital admissions in patients with malignant pleural effusion: a quality improvement study.

BACKGROUND: Malignant pleural effusions (MPE) can cause severe dyspnoea leading to greater than 125 000 hospitalisations per year and cost greater than US$5 billion per year in the USA. Timely insertion of tunnelled pleural catheters (TPCs) is associated with fewer inpatient days and emergency department visits. We conducted a quality improvement study to reduce hospital admissions of patients with MPE. METHODS: Key stakeholders were surveyed, including thoracic and breast oncology teams, general pulmonary and interventional pulmonology (IP) to help identify the underlying causes and solutions. Our preintervention group consisted of 51 patients who underwent TPC placement by our IP service. In our first intervention, we reviewed referrals for MPE with the scheduling team and triaged them based on urgency. In the second intervention, we added a follow-up phone call 1 week after the initial thoracentesis performed by IP to assess for the recurrence of symptoms. RESULTS: Demographic and clinical characteristics were summarised across the three groups. We evaluated the rate ratio (RR) of admissions in the intervention groups with the multivariable Poisson regression and adjusted for race, gender and cancer. Compared with the preintervention group, intervention I showed trends towards a 41% lower hospital admission rate (RR 0.59 (0.33-1.07), p=0.11). Compared with the preintervention group, intervention II showed trends towards a 40% lower hospital admission rate (RR 0.6 (0.36-0.99), p=0.07). The results did not reach statistical significance. Exploratory comparisons in readmission rates between interventions I and II showed no difference (RR 0.89 (0.43-1.79), p=0.75). CONCLUSIONS: Both interventions showed trends toward fewer hospital readmissions although they were not statistically significant. Larger-size prospective studies would be needed to demonstrate the continued effectiveness of these interventions.

Safety and utility of indwelling pleural catheters in lung transplant recipients.

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.

Bronchoscopy in Patients With Known or Suspected COVID-19: Results From the Global Pandemic SARS-CoV-2 Bronchoscopy Database (GPS-BD).

BACKGROUND: Amid the Coronavirus Disease 2019 (COVID-19) pandemic, the benefits and risks of bronchoscopy remain uncertain. This study was designed to characterize bronchoscopy-related practice patterns, diagnostic yields, and adverse events involving patients with known or suspected COVID-19. METHODS: An online survey tool retrospectively queried bronchoscopists about their experiences with patients with known or suspected COVID-19 between March 20 and August 20, 2020. Collected data comprised the Global Pandemic SARS-CoV-2 Bronchoscopy Database (GPS-BD). All bronchoscopists and patients were anonymous with no direct investigator-to-respondent contact. RESULTS: Bronchoscopy procedures involving 289 patients from 26 countries were analyzed. One-half of patients had known COVID-19. Most (82%) had at least 1 pre-existing comorbidity, 80% had at least 1 organ failure, 51% were critically ill, and 37% were intubated at the time of the procedure. Bronchoscopy was performed with diagnostic intent in 166 (57%) patients, yielding a diagnosis in 86 (52%). and management changes in 80 (48%). Bronchoscopy was performed with therapeutic intent in 71 (25%) patients, mostly for secretion clearance (87%). Complications attributed to bronchoscopy or significant clinical decline within 12 hours of the procedure occurred in 24 (8%) cases, with 1 death. CONCLUSION: Results from this international database provide a widely generalizable characterization of the benefits and risks of bronchoscopy in patients with known or suspected COVID-19. Bronchoscopy in this setting has reasonable clinical benefit, with diagnosis and/or management change resulting from about half of the diagnostic cases. However, it is not without risk, especially in patients with limited physiological reserve.

Diagnostic Yield of Digital Tomosynthesis-assisted Navigational Bronchoscopy for Indeterminate Lung Nodules.

BACKGROUND: Navigational bronchoscopy is commonly used to sample lung nodules, with a better safety profile but lower diagnostic yield than computerized tomography-guided transthoracic needle biopsy. The addition of digital tomosynthesis to electromagnetic navigation, using intraprocedural images obtained from a C-arm fluoroscope to identify target lesion location and update navigational guidance, may improve diagnostic yield. METHODS: Consecutive bronchoscopies using tomosynthesis-assisted fluoroscopic electromagnetic navigational bronchoscopy (F-ENB) at a single institution over a 1-year period were included. The primary outcome was diagnostic yield. A bronchoscopy was defined as diagnostic if pathologic examination revealed malignancy or specific histological findings indicative of lesional sampling with confirmatory 6-month follow-up for benign lesions. RESULTS: A total of 324 patients with 363 nodules underwent F-ENB between April 25, 2018 and April 29, 2019. The average nodule size was 1.9±1.1 cm, 65% of the nodules were located in the peripheral third of the lung. A bronchus sign was present in 24% of cases. Of the 363 nodules, 299 (82.4%) had lesional findings. At 6-month follow-up, among these 299 nodules, 6 were found to be false negatives and 12 nodules were lost to follow-up. Considering all nodules lost to follow-up as false negatives, the 6-month diagnostic yield was 77.4%. Pneumothorax complicated 8 (2.5%) of cases. There was 1 episode of respiratory failure. CONCLUSION: This retrospective study suggests the diagnostic yield of F-ENB may exceed that of traditional ENB. Future prospective and comparative studies are needed to confirm these promising data.

Cryobiopsy With Radial UltraSound Guidance (CYRUS): A Pilot Randomized Controlled Study.

BACKGROUND: Major airway bleeding is the most feared complication of transbronchial cryobiopsy (TBC). Radial endobronchial ultrasound (REBUS) has been used to assess the peripheral lung, primarily to identify pulmonary nodules, and also peripheral blood vessels. Using REBUS-guided TBC to avoid peripheral vasculature might reduce bleeding risk. This prospective randomized double-blind pilot trial was designed to investigate the feasibility of study procedures and inform the power calculation and clinical significance of a future large randomized trial. METHODS: Consecutive TBCs were randomized to be performed with or without REBUS guidance in the same patient. A nonblinded operator obtained each biopsy while a blinded second operator managed the bleeding after each biopsy and determined when hemostasis had been obtained. Feasibility of study procedures and the ability to recruit patients were of primary interest. Time to hemostasis after each biopsy was also examined. RESULTS: Forty TBCs were performed in 10 patients (4 biopsies per patient) over an enrollment period of 6 months. The time to control bleeding between biopsies was not statistically different between intervention and control arms [-14.3 (-120.1 to 92.0) s, P=0.7878]. Mean bleeding time was 139.4±59.895 seconds (REBUS 132.25± 89.305 s, non-REBUS 146.55±82.043 s). A trend towards the decreased grade of bleeding and less need for additional interventions was observed with REBUS use, but this difference did not reach statistical significance in this pilot investigation. CONCLUSION: Our findings suggest that REBUS-guided TBC is feasible. We did not observe any statistically significant difference in time to hemostasis or bleeding grade in this pilot study.

Improved diagnostic yield for lung nodules with digital tomosynthesis-corrected navigational bronchoscopy: Initial experience with a novel adjunct.

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.

The Impact of Gravity vs Suction-driven Therapeutic Thoracentesis on Pressure-related Complications: The GRAVITAS Multicenter Randomized Controlled Trial.

BACKGROUND: Thoracentesis can be accomplished by active aspiration or drainage with gravity. This trial investigated whether gravity drainage could protect against negative pressure-related complications such as chest discomfort, re-expansion pulmonary edema, or pneumothorax compared with active aspiration. METHODS: This prospective, multicenter, single-blind, randomized controlled trial allocated patients with large free-flowing effusions estimated ≥ 500 mL 1:1 to undergo active aspiration or gravity drainage. Patients rated chest discomfort on 100-mm visual analog scales prior to, during, and following drainage. Thoracentesis was halted at complete evacuation or for persistent chest discomfort, intractable cough, or other complication. The primary outcome was overall procedural chest discomfort scored 5 min following the procedure. Secondary outcomes included measures of discomfort and breathlessness through 48 h postprocedure. RESULTS: A total of 142 patients were randomized to undergo treatment, with 140 in the final analysis. Groups did not differ for the primary outcome (mean visual analog scale score difference, 5.3 mm; 95% CI, -2.4 to 13.0; P = .17). Secondary outcomes of discomfort and dyspnea did not differ between groups. Comparable volumes were drained in both groups, but the procedure duration was significantly longer in the gravity arm (mean difference, 7.4 min; 95% CI, 10.2 to 4.6; P < .001). There were no serious complications. CONCLUSIONS: Thoracentesis via active aspiration and gravity drainage are both safe and result in comparable levels of procedural comfort and dyspnea improvement. Active aspiration requires less total procedural time. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT03591952; URL: www.clinicaltrials.gov.

Persistent focal pulmonary opacity elucidated by transbronchial cryobiopsy: a case for larger biopsies.

Persistent pulmonary opacities associated with respiratory symptoms that progress despite medical treatment present a diagnostic dilemma for pulmonologists. We describe the case of a 37-year-old woman presenting with progressive fatigue, shortness of breath, and weight loss over six months with a progressively worsening right basilar infiltrate on chest imaging in spite of antibacterial therapy. Transbronchial cryobiopsy was used to establish the diagnosis after a bronchoscopy with traditional forceps biopsies was non-diagnostic. This case demonstrates the value of cryobiopsy as a second-line strategy for pulmonary infiltrates when aetiology remains unclear after less invasive testing.

Routine monitoring with pleural manometry during therapeutic large-volume thoracentesis to prevent pleural-pressure-related complications: a multicentre, single-blind randomised controlled trial.

BACKGROUND: In patients with non-expandable lung, removal of pleural fluid can result in excessively negative pleural pressure, which is associated with chest discomfort, pneumothorax, and re-expansion pulmonary oedema. Pleural manometry is widely used to safeguard against pressure-related complications during thoracentesis despite little evidence to support the approach. We investigated whether monitoring of pleural pressure with manometry during thoracentesis could protect against complications compared with assessment of symptoms alone. METHODS: We did a prospective randomised single-blind trial involving patients with large pleural effusions at two academic medical centres in, Nashville, TN, and Baltimore, MD, USA. Eligible patients were adults with free-flowing effusions estimated to be at least 0·5 L who could remain seated throughout the procedure. Patients were randomly assigned 1:1 to receive thoracentesis guided by symptoms only (control) or by symptoms plus manometry at timepoints based on volume drained. The randomisation schedule was computer generated, used permuted blocks of four and six, and was stratified by participating institution. Patients, who were masked to study-group assignment, were asked to rate chest discomfort on 100 mm visual analogue scales before, during, and after drainage. In both groups drainage was discontinued before complete evacuation of pleural fluid if patients developed persistent chest discomfort, intractable cough, or other complications. In the manometry group, an additional criterion for stopping was if end-expiratory pleural pressure was lower than -20 cm H2O or declined by more than 10 cm H2O between two measurements to a value less than or equal to -10 cm H2O. The primary outcome was overall chest discomfort from before the start to after the procedure measured by patients 5 min after the end of drainage. Analysis was by modified intention to treat (ie, included all patients with any procedure or outcome data). This trial is registered with ClinicalTrials.gov, number NCT02677883. FINDINGS: Between March 4, 2016, and Sept 8, 2017, 191 patients were screened, of whom 128 were randomly assigned treatment and 124 were included in the final analysis (62 in each group). Four patients were excluded because of manometer malfunction (n=2), inability to access effusion due to pleural tumour burden (n=1), and inability to remain seated (n=1). Groups did not differ for the primary outcome (mean difference in chest discomfort score 2·4 mm, 95% CI -5·7 to 10·5, p=0·56). Six (10%) of 62 patients in the control group had asymptomatic pneumothorax ex vacuo compared with none in the manometry group (p=0·01). No serious complications occurred in either group. INTERPRETATION: Measurement of pleural pressure by manometry during large-volume thoracentesis does not alter procedure-related chest discomfort. Our findings do not support the routine use of this approach. FUNDING: Centurion Medical Products.

Community Consultation for Planned Emergent Use Research: Experiences From an Academic Medical Center.

BACKGROUND: Emergent use research-research involving human subjects that have a life-threatening medical condition and who are unlikely to provide informed consent-in critical illness is fraught with challenges related to obtaining informed consent. Per federal regulations, to meet criteria to conduct such trials, the investigators have to seek community consultations. Effective ways of obtaining this consultation remains ill-defined. OBJECTIVE: We sought to describe methods, interpretations, and our experiences of conducting community consultation in a planned emergent use randomized controlled trial. METHODS: As part of a planned emergent use clinical trial in our study, community consultation consisted of four focus groups sessions with members from the community in which the clinical trial was conducted. Three focus group sessions were conducted with members who had an affiliation to Mayo Clinic, and the other focus group session was conducted with non-Mayo affiliation members. The feedback from the focus group sessions led to the creation of the public notification plan. The public was notified of the trial through community meetings as well as social media. RESULTS: As compared to community meetings, focus group sessions resulted in greater attendance with more interactive discussions. Moreover, focus group sessions resulted in greater in-depth conversations leading to institutional acceptance of the clinical trial under study. CONCLUSIONS: Exception from informed consent can be acceptable to the community. Focus groups provided better participation and valuable interactive insight as compared to community meetings in our study. This could serve as a valuable guide for investigators pursuing exception from informed consent in their research studies.

Timing of Intubation in Acute Respiratory Failure Associated With Sepsis: A Mixed Methods Study.

OBJECTIVE: To analyze bedside clinicians' perspectives regarding the decision process to optimize timing of intubation in sepsis-associated acute respiratory failure. PARTICIPANTS AND METHODS: This mixed methods study was conducted from March 1, 2015, through June 30, 2016. Using qualitative research methods, factors that influenced variability in the decision to intubate were organized into categories and used to build a theoretical explanatory model grounded in current practice variance. All coding schemes were independently reviewed for accuracy and consistency. Themes and findings were then refined with member checking by feedback from individuals and from an anonymous questionnaire until saturation was achieved. RESULTS: The practice of intubation varied according to 3 domains: (1) patient factors included the nature of the acute illness, comorbidities, clinical presentation, severity, trajectory, and values and preferences; (2) clinician factors included background, training, experience, and practice style; and (3) system factors included workload, policies and protocols, hierarchy, communications, culture, and team dynamics. In different contexts, intubation was considered early (elective), just in time (urgent), or late (rescue). The initial assessment, initial decision, and reassessment mattered. CONCLUSION: Recognizing that the variability in both the decision to intubate and its timing depends on many factors, and not on clinical criteria alone, should render the clinician more attentive to the eventual progression of the acute respiratory failure.

Impact of Telemedicine Monitoring of Community ICUs on Interhospital Transfers.

OBJECTIVES: To study the effects of tele-ICU monitoring on interhospital transfers from community-based ICUs to the quaternary care hospital at Mayo Clinic, Rochester, MN. DESIGN: This is a retrospective review of data on interhospital transfers comparing trends prior to tele-ICU implementation to those following implementation. SETTING: Tele-ICU programs are increasingly utilized to fill resource gaps in caring for critically ill patients. How such programs impact population and bed management within a healthcare system are not known. Mayo Clinic serves as quaternary referral care center for hospitals in the region within the Mayo Clinic Health System. In August 2013, we implemented tele-ICU monitoring at six Mayo Clinic Health System hospital ICUs. SUBJECTS: All adult ICU admissions during the study period (preimplementation phase: January 1, 2012, to December 31, 2012; and postimplementation phase: January 1, 2014, to December 31, 2014) in any of the six specified community ICUs were included in the study. MEASUREMENTS AND MAIN RESULTS: Interhospital transfers significantly increased post institution of tele-ICU (p = 0.040) and was attributed primarily to transfer from less specialized ICUs (p = 0.037) as compared with more resource-intensive ICUs (p = 0.88). However, for such patient transfers, there were no significant differences before and after severity of illness scores, ICU mortality, or inhospital mortality. CONCLUSION: In a regional healthcare system, implementation of a tele-ICU program is associated with an increase in interhospital transfers from less resourced ICUs to the referral center, a trend that is not readily explained by increased severity of illness.

Tunneled Indwelling Pleural Catheters for Refractory Pleural Effusions after Solid Organ Transplant. A Case-Control Study.

RATIONALE: The use of tunneled indwelling pleural catheters for management of refractory pleural effusions continues to increase. Pleural space infections are among the most common and serious complication of the procedure. The risk may be higher in patients receiving immunosuppressive medications. OBJECTIVES: The aim of this study was to assess the risk of infections complicating placement of a tunneled indwelling pleural catheter in patients who have received a solid organ transplant. METHODS: Electronic medical records were retrospectively reviewed to identify patients with prior solid organ transplant who subsequently underwent placement of a tunneled intrapleural catheter. We selected a matched sample of comparison patients without solid organ transplant who underwent the same procedure during the study period. Detailed chart abstraction was performed to compare baseline clinical information with procedure outcomes in both groups. MEASUREMENTS AND MAIN RESULTS: Nineteen study patients underwent kidney, liver, lung, or heart transplant. Another 55 patients were included in the nontransplant comparison group. Transplant patients were taking a mean of 2.4 (range, 1-4) immunosuppressive medications. In transplant patients, the intrapleural catheter remained in place for a median of 95 days (interquartile range, 58-256 d). Two of the 19 transplant patients (16.9% 90-day Kaplan-Meier estimate) and 4 of the 55 control patients (11.0% weighted 90-day Kaplan-Meier estimate) developed a major infectious complication (not significant). There were no deaths attributed to intrapleural catheter placement in either group. CONCLUSIONS: In a series of 19 patients with solid organ transplantation taking daily immunosuppressive medications who underwent placement of a tunneled intrapleural catheter, we report an 11% rate of major infectious complications over the lifetime of the catheter in the transplant group with no significant difference in 90-day estimated risk of complication between transplant and nontransplant comparison group.