[A cross-sectional study in three German hospitals regarding oxygen therapy characteristics]. / Eine Querschnittsuntersuchung zur Qualität der Sauerstofftherapie in drei deutschen Krankenhäusern.

BACKGROUND: Oxygen (O2) therapy is one of the most commonly applied medications in German hospitals and rescue services. Both hypoxemia and hyperoxemia can be associated with complications. There is currently a lack of reliable data on the use, documentation and surveillance of O2-therapy in German hospitals. METHODS: We conducted a cross-sectional study on the use of O2 in three hospitals in Hannover, Germany. RESULTS: Of 343 patients included in this study, 20 % received O2 therapy. Twenty-nine percent of patients receiving O2 were at increased risk for hypercapnia. A standard operating procedure (SOP) for O2 therapy was available in only 68 % of patients. In 22 % patients the applied O2-therapy was appropriate in the context of the documented vital parameters. A complete documentation of vital parameters was conducted in only 30 % of all patients and 41 % of patients receiving O2-therapy. A surveillance of O2-therapy using capillary or arterial blood gas analysis was performed in 76 % of patients. Here, 64 % of patients showed normoxemia, 17 % showed hyperoxemia and 19 % of patients showed hypoxemia. The only identifiable predictor for an adequate O2-therapy was a previous invasive ventilation. DISCUSSION: Our data point towards and inadequate prescription, application and documentation of O2 therapy. The recently released German S3-guideline should be used to increase awareness among physicians and nursing staff regarding the use of O2-therapy to improve O2 therapy and consequently patient safety.

[A cross-sectional study in three German hospitals regarding oxygen therapy characteristics]. / Eine Querschnittsuntersuchung zur Qualität der Sauerstofftherapie in drei deutschen Krankenhäusern.

BACKGROUND: Oxygen (O2) therapy is one of the most commonly applied medications in German hospitals and rescue services. Both hypoxemia and hyperoxemia can be associated with complications. There is currently a lack of reliable data on the use, documentation and surveillance of O2-therapy in German hospitals. METHODS: We conducted a cross-sectional study on the use of O2 in three hospitals in Hannover, Germany. RESULTS: Of 343 patients included in this study, 20 % received O2 therapy. Twenty-nine percent of patients receiving O2 were at increased risk for hypercapnia. A standard operating procedure (SOP) for O2 therapy was available in only 68 % of patients. In 22 % patients the applied O2-therapy was appropriate in the context of the documented vital parameters. A complete documentation of vital parameters was conducted in only 30 % of all patients and 41 % of patients receiving O2-therapy. A surveillance of O2-therapy using capillary or arterial blood gas analysis was performed in 76 % of patients. Here, 64 % of patients showed normoxemia, 17 % showed hyperoxemia and 19 % of patients showed hypoxemia. The only identifiable predictor for an adequate O2-therapy was a previous invasive ventilation. DISCUSSION: Our data point towards and inadequate prescription, application and documentation of O2 therapy. The recently released German S3-guideline should be used to increase awareness among physicians and nursing staff regarding the use of O2-therapy to improve O2 therapy and consequently patient safety.

Five-year Outcome of an Early Everolimus-based Quadruple Immunosuppression in Lung Transplant Recipients: Follow-up of the 4EVERLUNG Study.

BACKGROUND: Everolimus-based quadruple low calcineurin inhibitor (CNI) maintenance immunosuppression has been shown to be effective in preserving short-term renal function without compromising efficacy or safety after lung transplantation; however, long-term benefit remains unknown. METHODS: An investigator-initiated 5-y follow-up analysis of the 4EVERLUNG study (NCT01404325), comparing everolimus-based quadruple low CNI with standard triple regimen, was performed. Patients who remained on the randomized drug regimen until the end of the 5-y observation were analyzed as the per protocol (PP) population. Patients in whom the assigned regimen was switched were analyzed as the intention-to-treat (ITT) population. RESULTS: In total, 123 patients (95%) from the core study were analyzed. During the observation period in 11 patients (19%) of the standard triple regimen and in 30 patients (46%) of the quadruple low CNI regimen, the assigned immunosuppressive regimen was switched ( P = 0.002). Estimated glomerular filtration rate at 5-y follow-up did not differ between the groups in both the ITT (56 [48-73] versus 58 [48-69] mL/min; P =0.951) and PP (59 [50-73] versus 59 [48-69] mL/min; P = 0.946) populations. Thromboembolic events occurred more frequently in the quadruple low CNI regimen (ITT: 11% versus 24%, P = 0.048; PP: 11% versus 22%, P = 0.162). There was a trend for a higher chronic lung allograft dysfunction-free survival for the quadruple low CNI regimen in the PP population ( P = 0.082). No difference in the graft survival was found. CONCLUSIONS: Initiation of an early everolimus-based quadruple low CNI regimen may have no long-term benefit on renal function. The immunosuppressive efficacy and safety profile seems comparable with the standard triple regimen.

Graphic narrative based informed consent for bronchoscopy improves satisfaction in patients after lung-transplantation: A randomized controlled trial.

OBJECTIVE: This study investigated the effects of supplementing standard informed consent (IC) with a graphic narrative on patient satisfaction, periprocedural anxiety and experience. METHODS: Patients due to undergo first conscious surveillance bronchoscopy following lung transplantation were randomized to receive IC with (intervention group) or without (control group) a graphic narrative illustrating the procedure. The primary endpoint was overall patient satisfaction with the IC. Key secondary endpoints were change in state anxiety level, as measured by State Trait Anxiety Inventory, and a questionnaire assessing satisfaction with IC and adverse experience during bronchoscopy (judged by patient and examiners). RESULTS: Sixty patients were randomized, and 59 patients were included in the analysis (30 intervention-group; 29 control-group). Overall patient satisfaction was higher in the intervention group 9.5 (25Q-75Q: 8.6-9.8) vs. 8.6 (25Q-75Q: 8.1-9.2), p = 0.028). Change in state anxiety level (before vs after informed consent) was similar between the groups. There were no significant differences in adverse experience during bronchoscopy. CONCLUSION: Addition of a graphic narrative illustrating bronchoscopy improved patient satisfaction with IC but did not influence anxiety before and adverse experience during the procedure. PRACTICE IMPLICATIONS: Supplementing the IC process with a procedure-specific graphic narrative may be a simple tool to improve patient satisfaction.

Clinical decision making is improved by BioFire Pneumonia Plus in suspected lower respiratory tract infection after lung transplantation: Results of the prospective DBATE-IT study.

BACKGROUND: Lower respiratory tract infections (LRTIs) are a significant cause of morbidity and mortality in lung transplant (LTx) recipients. Timely and precise pathogen detection is vital to successful treatment. Multiplex PCR kits with short turnover times like the BioFire Pneumonia Plus (BFPPp) (manufactured by bioMérieux) may be a valuable addition to conventional tests. METHODS: We performed a prospective observational cohort study in 60 LTx recipients with suspected LRTI. All patients received BFPPp testing of bronchoalveolar lavage fluid in addition to conventional tests including microbiological cultures and conventional diagnostics for respiratory viruses. Primary outcome was time-to-test-result; secondary outcomes included time-to-clinical-decision and BFPPp test accuracy compared to conventional tests. RESULTS: BFPPp provided results faster than conventional tests (2.3 h [2-2.8] vs. 23.4 h [21-62], p < 0.001), allowing for faster clinical decisions (2.8 [2.2-44] vs. virology 28.1 h [23.1-70.6] and microbiology 32.6 h [4.6-70.9], both p < 0.001). Based on all available diagnostic modalities, 26 (43%) patients were diagnosed with viral LRTI, nine (15 %) with non-viral LRTI, and five (8 %) with combined viral and non-viral LRTI. These diagnoses were established by BFPPp in 92%, 78%, and 100%, respectively. The remaining 20 patients (33 %) received a diagnosis other than LRTI. Preliminary therapies based on BFPPp results were upheld in 90% of cases. There were six treatment modifications based on pathogen-isolation by conventional testing missed by BFPPp, including three due to fungal pathogens not covered by the BFPPp. CONCLUSION: BFPPp offered faster test results compared to conventional tests with good concordance. The absence of fungal pathogens from the panel is a potential weakness in a severely immunosuppressed population.

Disease progression in patients with the restrictive and mixed phenotype of Chronic Lung Allograft dysfunction-A retrospective analysis in five European centers to assess the feasibility of a therapeutic trial.

BACKGROUND: Chronic Lung Allograft Dysfunction (CLAD) is a major obstacle for long term survival after lung transplantation (LTx). Besides Bronchiolitis Obliterans Syndrome, two other phenotypes of CLAD, restrictive allograft syndrome (RAS) and mixed phenotype, have been described. Trials to test in these conditions are desperately needed and analyzing natural outcome to plan such trials is essential. METHODS: We performed a retrospective analysis of functional outcome in bilateral LTx recipients with RAS and mixed phenotype, transplanted between 2009 and 2018 in five large European centers with follow- up spirometry up to 12 months after diagnosis. Based on these data, sample size and power calculations for randomized therapeutic trial was estimated using two imputation methods for missing values. RESULTS: Seventy patients were included (39 RAS and 31 mixed phenotype), median 3.1 years after LTx when CLAD was diagnosed. Eight, 13 and 25 patients died within 6, 9 and 12 months after diagnosis and a two patients underwent re-transplantation within 12 months leading to a graft survival of 89, 79 and 61% six, nine and 12 months after diagnosis, respectively. Observed FEV1 decline was 451 ml at 6 months and stabilized at 9 and 12 months, while FVC showed continuous decline. Using two methods of imputation, a progressive further decline after 6 months for FEV1 was noted. CONCLUSION: The poor outcome of these two specific CLAD phenotypes suggests the urgent need for future therapeutic randomized trials. The number of missing values in a potential trial seems to be high and most frequently attributed to death. Survival may be used as an endpoint in clinical trials in these distinct phenotypes and imputation techniques are relevant if graft function is used as a surrogate of disease progression in future trials.

The Transplant Evaluation Rating Scale Predicts Clinical Outcomes 1 Year After Lung Transplantation: A Prospective Longitudinal Study.

Objectives: It has been recommended that all candidates for lung transplantation undergo pre-transplant psychosocial evaluation for risk assessment. However, psychosocial issues are only important if they correlate with outcomes after transplantation. Methods: In this prospective study patients who were referred for lung transplantation from 2016 to 2018 (n = 352) at Hannover Medical School were evaluated using the Transplant Evaluation Rating Scale (TERS). Clinical outcomes included listing, and post-transplant outcomes including mortality, medical aspects such as lung allograft dysfunction, hospitalizations, and renal function, behavioral aspects such as BMI and adherence, and mental issues such as levels of depression, anxiety, and quality of life. TERS scores were divided into tertiles and, in addition, the impact of the two subscale scores-"defiance" and "emotional sensitivity"-was investigated. Results: Of the patients who were transplanted (n = 271) and were still alive (n = 251), 240 had already reached their 1-year assessment at the end of 2020 and were evaluated 1 year after the operation. A subgroup of 143 received an extended mental assessment. BMI, adherence scores, levels of anxiety, depression, and quality of life 1 year post-transplantation differed significantly between TERS tertiles with higher TERS scores predicting less favorable outcomes. The TERS subscale "defiance" was predictive of BMI and adherence whereas the TERS subscale "emotional sensitivity" was predictive of symptoms of anxiety and depression, and quality of life 1 year after transplantation. Patients in the lowest TERS tertile were more likely to having been listed and-as a trend-to having survived the first year after transplantation Conclusions: Our findings show that psychosocial factors as measured by TERS score are predictors of behavioral and mental outcomes 1 year after lung transplantation. The TERS allows us to focus on psychosocial risk factors that can be treated or minimized before or after transplantation.

A Before-and-After Study of Evidence-Based Recommendations for On-Call Bronchoscopy.

BACKGROUND: Bronchoscopy is widely used and regarded as standard of care in most intensive care units (ICUs). Data concerning recommendations for on-call bronchoscopy are lacking. OBJECTIVES: Evaluation of recommendations, complications, and outcome of on-call bronchoscopies. METHOD: A retrospective single-centre analysis was conducted in a large university hospital. All on-call bronchoscopies performed outside normal working hours in the year before (period 1) and after (period 2) establishing a catalogue of recommendations for indications of on-call bronchoscopy on November 1, 2016, were included. RESULTS: Overall, 924 bronchoscopies in 538 patients were analysed. A relative reduction of 83.6% from 794 bronchoscopies in 432 patients (1.84 per patient) during period 1 to 130 in 107 patients (1.21 per patient) during period 2 was observed. Most bronchoscopies (812/924, 87.9%) were performed in ICUs, and 416 patients (77.3%) were intubated. Bronchoscopies for excessive secretions decreased significantly during period 2. Fifty-three of 130 bronchoscopies (40.8%) fulfilled the specified recommendations during period 2, in comparison with 16.8% in period 1 (p < 0.001). Complications were recorded in 58 of 924 procedures (6.3%) and were more frequent in period 2, especially moderate bleeding. In-hospital mortality of patients undergoing on-call bronchoscopy did not differ between periods and was 28.7 and 30.2% in periods 1 and 2, respectively. CONCLUSION: The introduction of recommendations for on-call bronchoscopy led to a significant decline of on-call bronchoscopies without negatively affecting outcome. More evidence is needed in on-call bronchoscopy, especially for ICU patients with intrinsic higher complication rates.

Characteristics and clinical implications of pleural effusions after lung transplantation: A retrospective analysis of 195 thoracocenteses in 113 patients.

Despite advances in lung transplantation (LTx), morbidity, and mortality are high. We hypothesized that pleural effusions requiring thoracocentesis lead to poor outcomes after LTx. We performed a single-center retrospective analysis of thoracocenteses after initial hospital discharge in LTx patients between March 2008 and September 2020 to identify risk factors, etiologies, and outcomes. Of the 1223 patients included, 113 patients (9.2%) required a total of 195 thoracocenteses. The cumulative incidence of thoracocentesis was 10.6% at 1 year and 14.2% at 5 years after transplantation. We observed a bimodal distribution of pleural effusion onset with a threshold at 6 months. Late-onset effusions were mostly of malignant or cardiac origin. We observed a high rate of nonspecific effusions (41.5%) irrespective of the timepoint post-transplantation. Patients with late-onset effusions had significantly lower survival compared to a matched controlled group (HR 2.43; 95% CI (1.27-4.62). All pulmonary function parameters were significantly decreased in patients requiring thoracocentesis compared to matched controls. Male sex and re-transplantation were risk factors for pleural effusions. In conclusion, pleural effusions requiring thoracocentesis occur frequently in LTx patients and lead to a reduced long-term allograft function. Late-onset effusions are associated with a lower survival.

Video Consultation During the COVID-19 Pandemic: A Single Center's Experience with Lung Transplant Recipients.

Background: The coronavirus disease 2019 (COVID-19) pandemic has disrupted health care systems worldwide. This is due to both to the reallocation of resources toward COVID-19 patients as well as concern for the risk of nosocomial severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) exposure. The interruption of routine care is especially problematic for patients with chronic conditions requiring regular follow-up, such as lung transplant (LTx) recipients. Introduction: New methods such as telemedicine are needed to bridge the gap in follow-up care caused by the pandemic. Materials and Methods: A retrospective analysis of video consultations (VCs) in comparison with on-site visits (OSVs) was performed during a 6-week period in an LTx center in Germany. VC included a structured work-up questionnaire and vital sign documentation. Results: During the 6-week study period, 75 VCs were performed for 53 patients and 75 OSVs by 51 patients occurred. By the end of our study period, 77% of physician-patient contacts occurred through VC. Physician-patient consultations were reduced by 47% compared with the equivalent time frame in 2019. In 62% of cases, VC resulted in a concrete clinical decision. One COVID-19 patient in home quarantine was admitted due to respiratory failure detected by VC. Patient satisfaction with VC was high. Discussion: Implementation of VC helped to reduce the need for OSV and thus the risk of SARS-CoV-2 exposure in our patient cohort. This technology can be adopted to provide care for a wide range of chronic illnesses. Conclusions: VC can preserve access to specialist care while reducing SARS-CoV-2 exposure for patients with chronic illnesses during the pandemic.