Robotic versus Electromagnetic bronchoscopy for pulmonary LesIon AssessmeNT: the RELIANT pragmatic randomized trial.

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.

Variability in Provider Assessment of Sepsis and Potential of Host Response Technology to Address this Dilemma-Results of an Online Delphi Study.

Potentially septic patients have a huge clinical and economic impact on hospitals and often present to the emergency department (ED) with undifferentiated symptoms. The triage of these patients is complex and has historically relied heavily upon provider judgment. This study aims to evaluate the consistency of provider judgment and the potential of a new host response sepsis test to aid in the triage process. A modified Delphi study involving 26 participants from multiple specialties was conducted to evaluate provider agreement about sepsis risk and to test proposed actions based on the results of a sepsis test. The participants considered case vignettes of potentially septic patients designed to represent diagnostic dilemmas. Provider assessment of sepsis risk in these cases ranged from 10% to 90% and agreement was poor. Agreement about clinical actions to take in response to testing improved when participants considered their own hypothetical borderline cases. New host response testing for sepsis may have the potential to improve sepsis diagnosis and care and should be applied in a protocolized fashion to ensure consistency of results.

Robotic versus Electromagnetic Bronchoscopy for Pulmonary LesIon AssessmeNT: the RELIANT pragmatic randomized trial.

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.

Using a multicultural and multilingual awareness-raising strategy to enhance enrollment of racially underrepresented minoritized communities - the PassITON trial.

Racially and ethnically minoritized populations have been historically excluded and underrepresented in research. This paper will describe best practices in multicultural and multilingual awareness-raising strategies used by the Recruitment Innovation Center to increase minoritized enrollment into clinical trials. The Passive Immunity Trial for Our Nation will be used as a primary example to highlight real-world application of these methods to raise awareness, engage community partners, and recruit diverse study participants.

Assessment of Awake Prone Positioning in Hospitalized Adults With COVID-19: A Nonrandomized Controlled Trial.

Importance: Awake prone positioning may improve hypoxemia among patients with COVID-19, but whether it is associated with improved clinical outcomes remains unknown. Objective: To determine whether the recommendation of awake prone positioning is associated with improved outcomes among patients with COVID-19-related hypoxemia who have not received mechanical ventilation. Design, Setting, and Participants: This pragmatic nonrandomized controlled trial was conducted at 2 academic medical centers (Vanderbilt University Medical Center and NorthShore University HealthSystem) during the COVID-19 pandemic. A total of 501 adult patients with COVID-19-associated hypoxemia who had not received mechanical ventilation were enrolled from May 13 to December 11, 2020. Interventions: Patients were assigned 1:1 to receive either the practitioner-recommended awake prone positioning intervention (intervention group) or usual care (usual care group). Main Outcomes and Measures: Primary outcome analyses were performed using a bayesian proportional odds model with covariate adjustment for clinical severity ranking based on the World Health Organization ordinal outcome scale, which was modified to highlight the worst level of hypoxemia on study day 5. Results: A total of 501 patients (mean [SD] age, 61.0 [15.3] years; 284 [56.7%] were male; and most [417 (83.2%)] were self-reported non-Hispanic or non-Latinx) were included. Baseline severity was comparable between the intervention vs usual care groups, with 170 patients (65.9%) vs 162 patients (66.7%) receiving oxygen via standard low-flow nasal cannula, 71 patients (27.5%) vs 62 patients (25.5%) receiving oxygen via high-flow nasal cannula, and 16 patients (6.2%) vs 19 patients (7.8%) receiving noninvasive positive-pressure ventilation. Nursing observations estimated that patients in the intervention group spent a median of 4.2 hours (IQR, 1.8-6.7 hours) in the prone position per day compared with 0 hours (IQR, 0-0.7 hours) per day in the usual care group. On study day 5, the bayesian posterior probability of the intervention group having worse outcomes than the usual care group on the modified World Health Organization ordinal outcome scale was 0.998 (posterior median adjusted odds ratio [aOR], 1.63; 95% credibility interval [CrI], 1.16-2.31). However, on study days 14 and 28, the posterior probabilities of harm were 0.874 (aOR, 1.29; 95% CrI, 0.84-1.99) and 0.673 (aOR, 1.12; 95% CrI, 0.67-1.86), respectively. Exploratory outcomes (progression to mechanical ventilation, length of stay, and 28-day mortality) did not differ between groups. Conclusions and Relevance: In this nonrandomized controlled trial, prone positioning offered no observed clinical benefit among patients with COVID-19-associated hypoxemia who had not received mechanical ventilation. Moreover, there was substantial evidence of worsened clinical outcomes at study day 5 among patients recommended to receive the awake prone positioning intervention, suggesting potential harm. Trial Registration: ClinicalTrials.gov Identifier: NCT04359797.

Safety and Feasibility of a Protocolized Daily Assessment of Readiness for Liberation From Venovenous Extracorporeal Membrane Oxygenation.

BACKGROUND: Decannulation from venovenous extracorporeal membrane oxygenation (ECMO) at the earliest and safest possible time may improve outcomes and reduce cost. Yet, no prospective studies have compared weaning strategies for liberation from ECMO. RESEARCH QUESTION: Is a protocolized daily assessment of readiness to liberate from venovenous ECMO safe and feasible? STUDY DESIGN AND METHODS: We conducted a prospective, single-arm safety and feasibility study of a protocol for daily assessment of readiness to liberate from venovenous ECMO among consecutive adult patients receiving venovenous ECMO across four ICUs at a single center between June 20, 2020, and November 24, 2020. The ECMO-free protocol included three phases: (1) the safety screening, (2) non-ECMO Fio2 titration, and (3) the ECMO-free trial. Enrollment, interventions, and data collection were performed prospectively by trained study staff. RESULTS: Twenty-six patients received the ECMO-free protocol on 385 patient-days. The safety screening was passed during a total of 59 ECMO-free daily assessments (15.3%) among 20 patients. Every passed safety screening proceeded to an ECMO-free trial. Twenty-eight passed ECMO-free trials (47.5%) occurred among 16 patients (61.5%). No missed safety screenings, protocol deviations, or adverse events occurred. Of the 16 patients who passed an ECMO-free trial, 14 patients (87.5%) were decannulated. Among decannulated patients, 12 patients (85.7%) were decannulated on the same day as a passed ECMO-free trial, 6 patients (42.9%) were decannulated on the first day that they passed an ECMO-free trial, and 6 patients (42.9%) passed an ECMO-free trial at least twice consecutively before decannulation. The median time from first passed ECMO-free trial to decannulation was 2 days (interquartile range, 0-3 days). INTERPRETATION: The ECMO-free protocol is feasible and may identify patients for decannulation earlier than gradual approaches to weaning.

Disposable Component Selection in Extracorporeal Life Support: A Cost Analysis.

Extracorporeal life support (ECLS) is a resource-intensive technology. Disposable components are modifiable through device selection. Cost analysis tools are needed to inform cost-conscious device selection. We generated a disposable cost analysis to forecast estimated costs of device disposables that included an assumption table, net present value (NPV) analysis, and sensitivity analysis to examine device disposable costs over 5 years with different case volumes and device mixes. To demonstrate the function of the analysis, we included four device options using the following assumptions: 100 cases in year 1, 2.5% case growth rate, 10% discount rate, and $5,000 incremental cost (Device 4 only). Using estimated device costs of $3,000, $12,000, $13,000, and $20,000 and device mix percentages of 65%, 8%, 25%, and 2% for Device 1, 2, 3, and 4, respectively, the 5 year unadjusted and NPV of disposable device costs were $3,691,000 and $2,765,000, respectively. The sensitivity analysis incorporated six separate models with different device mix percentages. The highest and lowest estimated costs were found in Model F (75% Device 3 and 25% Device 4; NPV = $6,64,400) and Model B (100% Device 1; NPV = 1,246,000) respectively. Extracorporeal life support programs may apply this disposable cost analysis tool to reduce programmatic costs.

Update on nutritional assessment and therapy in critical care.

PURPOSE OF REVIEW: To summarize recent data regarding nutritional assessment and interventions in the ICU. RECENT FINDINGS: Current methods to assess nutritional risk do not allow identification of ICU patients who may benefit from specific nutritional intervention. Early full energy delivery does not appear to improve outcomes at the population level. Specific nutrient composition of formula has been shown to improve glycemic outcomes in patients with hyperglycemia but patient-centered outcomes are unaffected. SUMMARY: Based on recent studies, full energy feeding early during critical illness has no measurable beneficial effect, and may even be harmful, when applied to entire populations. The mechanisms underlying this are unknown and remain proposed theories. Tools to assess nutritional risk in the ICU that identify patients who will benefit from a specific nutritional intervention are lacking. The optimal composition of feeds, and indications for specific interventions for enteral feeding intolerance remain uncertain.

Charge Reductions Associated With Shorter Time to Recovery in Septic Shock.

BACKGROUND: Septic shock therapies that shorten the time to physiologic and clinical recovery may result in financial savings. However, the financial implications of improving these nonmortal outcomes are not well characterized. Therefore, we quantified hospital charges associated with four outcomes: ICU length of stay, duration of invasive mechanical ventilation, duration of vasopressor use, and new renal replacement therapy. METHODS: This was an observational study using administrative data from a large academic hospital in the United States. The analysis included adults treated with vasopressors for septic shock in a medical ICU. Linear regression modeling with ordinary least square was used to estimate the incremental hospital charges associated with 1 day of ICU length of stay, 1 day of mechanical ventilation, 1 day of vasopressor use, and new renal replacement therapy. RESULTS: The study population included 587 adults with septic shock, including 180 (30.7%) who died in the hospital. The median charge for a septic shock hospitalization was $98,583 (interquartile range [IQR], $61,177-$136,672). Decreases in ICU length of stay, mechanical ventilation duration, and vasopressor duration of 1 day were associated with charge reductions of $15,670 (IQR, $15,023-$16,317), $15,284 (IQR, $13,566-$17,002), and $17,947 (IQR, $16,344-$19,549), respectively. Avoidance of new renal replacement therapy was associated with a charge reduction of $36,051 (IQR, $22,353-$49,750). CONCLUSIONS: Septic shock therapies that reduce the duration of organ support and ICU care have the potential to lead to substantial financial savings.

Validation of a Sequential Organ Failure Assessment Score using Electronic Health Record Data.

The sequential organ failure assessment (SOFA) score is a scoring system commonly used in critical care to assess severity of illness. Automated calculation of the SOFA score using existing electronic health record data would broaden its applicability. We performed a manual validation of an automated SOFA score previously developed at our institution. A retrospective analysis of a random subset of 300 patients from a previously published randomized trial of critically ill adults was performed, with manual validation of SOFA scores from the date of initial intensive care unit admission. Spearman's rank correlation coefficient, weighted Cohen's kappa, and Bland-Altman plots were used to assess agreement between manual and electronic versions of SOFA scores and between manual and electronic versions of their individual components. There was high agreement between manual and electronic SOFA scores (Spearman's rank correlation coefficient = 0.90, 95% CI 0.87-0.93). Renal and respiratory components had lower agreement (weighted Cohen's kappa = 0.63, 95% CI 0.53-0.73 for renal; weighted Cohen's kappa = 0.77, 95% CI 0.70-0.84 for respiratory). The area under the receiver operating characteristic curve (AUC) for 30-day in-hospital mortality was 0.77 (95% CI 0.68-0.84) for manual SOFA scores and 0.75 (95% CI 0.66-0.83) for automated SOFA scores. Automatic calculation of SOFA scores from the electronic health record is feasible and correlates highly with manually calculated SOFA scores. Both have similar predictive value for 30-day in-hospital mortality.

Derivation and validation of Spo2/Fio2 ratio to impute for Pao2/Fio2 ratio in the respiratory component of the Sequential Organ Failure Assessment score.

OBJECTIVE: The Sequential Organ Failure Assessment (SOFA) score is validated to measure severity of organ dysfunction in critically ill patients. However, in some practice settings, daily arterial blood gas data required to calculate the respiratory component of the SOFA score are often unavailable. The objectives of this study were to derive Spo2/Fio2 (SF) ratio correlations with the Pao2/Fio2 (PF) ratio to calculate the respiratory parameter of the SOFA score, and to validate the respiratory SOFA obtained using SF ratios against clinical outcomes. PATIENTS AND MEASUREMENTS: We obtained matched measurements of Spo2 and Pao2 from two populations: group 1-patients undergoing general anesthesia and group 2-patients from the acute respiratory distress syndrome network-low-vs. high-tidal volume for the acute respiratory management of acute respiratory distress syndrome database. Using a linear regression model, we first determined SF ratios corresponding to PF ratios of 100, 200, 300, and 400. Second, we evaluated the contribution of positive end-expiratory pressure (PEEP) on the relationship between SF and PF, for patients on PEEP in centimeters of water (cm H2O) of <8, 8-12, and >12. Third, we calculated the SOFA scores in a separate cohort of intensive care unit patients using the derived SF ratios and validated them against clinical outcomes. RESULTS: The total SOFA scores calculated using SF ratios and PF ratios were highly correlated (Spearman's rho 0.85, p < 0.001) in all patients and in the three stratified PEEP categories (<8 cm H2O, Spearman's rho 0.87, p < 0.001; PEEP 8-12 cm H20, Spearman's rho 0.85, p < 0.001; PEEP >12 cm H2O, Spearman's rho 0.85, p < 0.001). The respiratory SOFA scores based on SF ratios and PF ratios correlated similarly with intensive care unit length of stay and ventilator-free days, when validated in a cohort of critically ill patients. CONCLUSION: The total and respiratory SOFA scores obtained with imputed SF values correlate with the corresponding SOFA score using PF ratios. Both the derived and original respiratory SOFA scores similarly predict outcomes.