bluuebunny/crossref_metadata_2025_split huggingface dataset:
Respiratory Complications Between Cuffed and Uncuffed Endotracheal Tubes in Pediatric Respiratory Management After Palatoplasty: Single-Center Retrospective Cohort Study
Authors: Minoura Hironori , Ichino Takashi , Kitamura Masatomo 
Published: October 2023

OBJECTIVES:
We aimed to examine the associations between use of cuffed or uncuffed endotracheal tubes (ETTs) and complications during and after short-term intubation of post-palatoplasty patients without intrinsic lung disease.

DESIGN:
Retrospective cohort study.

SETTING:
Operating room and PICU.

PATIENTS:
Children without intrinsic lung disease who had undergone palatoplasty at a single institution. Inclusion criteria: intubation using ETTs with an internal diameter of 3.5 mm and postoperative management in the PICU. Exclusion criteria: 1) patients for whom ETTs with internal diameters other than 3.5 mm were used, 2) patients who had already been extubated in the operating room, and 3) patients who had a tracheostomy.

INTERVENTIONS:
None.

MEASUREMENTS AND MAIN RESULTS:
Eighty-seven patients were screened for eligibility; 71 met the inclusion criteria. Of the 71 patients, 41 (58%) with polyurethane-cuffed ETTs (PUC-ETTs) and 30 (42%) with uncuffed ETTs were enrolled. We failed to identify an association between type of PUC-ETT and the development of atelectasis (odds ratio [OR], 1.06; 95% CI, 0.35–3.20; p = 1.00). Similarly, we failed to identify an association between type of PUC-ETT and development of stridor (OR, 1.58; 95% CI, 0.43–5.81; p = 0.715) or hoarseness after extubation (OR, 7.03; 95% CI, 0.83–59.6; p = 0.10). At extubation, air leak pressure was higher in the PUC-ETT group than in the uncuffed ETT group (p < 0.001), a finding which was not evident at intubation. The number of patients who received IV dexamethasone and the cases of inhaled racemic epinephrine were not statistically significant.

CONCLUSIONS:
In this select population of post-palatoplasty infants without intrinsic lung disease, we failed to identify any association between type of ETT (cuffed or uncuffed) and greater odds of developing respiratory complications. Taken together with the 95% CI of the effect size, our data indicate continued uncertainty about type of ETT that should be used for short-term intubation.
Expression Patterns of Airway Fluid Cytokines From Intubated Children With Pediatric Acute Respiratory Distress Syndrome
Authors: Ripple Michael J. , Mohammad Ahmad F. , Stephenson Susan T. , Fitzpatrick Anne M. , Grunwell Jocelyn R. 
Published: October 2023

OBJECTIVES:
Pediatric acute respiratory distress syndrome (PARDS) is a heterogeneous illness affecting 6% of mechanically ventilated children and with an overall mortality of 17%. Studies in PARDS have mainly focused on plasma biomarkers which may not reflect airway biomarkers. We lack adequate understanding of the inflammatory mediators and underlying immune responses in the airways of PARDS patients. Our objective was to compare the levels of cytokines in the airway fluid of intubated children with severe versus nonsevere acute respiratory distress syndrome.

DESIGN:
Prospective observational cohort study.

SETTING:
Single 36-bed quaternary care academic safety-net hospital PICU.

PATIENTS:
Children intubated for acute respiratory failure between January 2018 and November 2021 stratified by Pediatric Acute Lung Injury Consensus Conference-1 criteria for PARDS.

INTERVENTIONS:
None.

MEASUREMENTS AND MAIN RESULTS:
We measured levels of 23 cytokines, chemokines, and protein biomarkers in the tracheal aspirate from 82 intubated children, between 14 days and 17 years old, at risk for or with PARDS. Levels of interleukin-4, -5, -7, -8, -12(p-70), -17a, -21, and fractalkine were higher in patients with severe versus nonsevere PARDS. There were no associations between airway and plasma cytokines.

CONCLUSIONS:
Proinflammatory cytokines are elevated in the airway fluid from intubated children with severe PARDS and reflect diverse patterns of airway inflammation.
Variations in Administrative Approvals During the COVID-19 Pandemic at Participating Sites in the Society of Critical Care Medicine Discovery Network Viral Infection and Respiratory Illness Universal Study: COVID-19 Registry: A Cross-Sectional Study
Authors: Bansal Vikas , Sharma Mayank , Deo Neha , Qamar Shahraz , Lyman Susan , Kumar Vishakha K. , Walkey Allan , Tekin Aysun , Singh Romil , Bogojevic Marija , Nawathe Pooja A. , Boman Karen , Retford Lynn , Gajic Ognjen , Kashyap Rahul ,   for the Society of Critical Care Medicine (SCCM) Discovery Viral Infection and Respiratory Illness Universal Study (VIRUS): COVID-19 Registry Investigator Group
Published: October 2023

OBJECTIVES:
There is a paucity of literature regarding administrative approvals required for clinical studies during a pandemic. We aimed to evaluate variation in duration of administrative approvals within the Viral Infection and Respiratory illness Universal Study (VIRUS): A Global COVID-19 Registry.

DESIGN, SETTING, AND SUBJECTS:
Survey analysis of 188 investigators who participated in the VIRUS: COVID-19 registry, a prospective, observational global registry database of 287 sites.

INTERVENTIONS:
None.

MEASUREMENTS AND MAIN RESULTS:
For each study site approved through December 8, 2020, we assessed the duration in days: 1) from institutional review board (IRB) submission to IRB approval, 2) from IRB approval to Research Electronic Data Capture (REDCap) access, 3) from REDCap access to first patient data entry in REDCap, and 4) total duration from IRB submission to first patient data entry in REDCap. Analysis of variance and Wilcoxon rank-sum test were used to compare time durations. Of 287 sites, 188 sites (United States = 155, non-United States = 33) provided complete administrative data. There was considerable variability in duration from IRB submission to first patient data entry with median (interquartile range) of 28 days (16–50 d), with differences not significantly different by country (United States: 30 [17–50] vs non-United States: 23 d [8–46 d]; p = 0.08) or previous “multisite trial experience” (experienced: 27 [15–51] vs not experienced: 29 d [13–47 d]; p = 0.67). The U.S. sites had a higher proportion of female principal investigators (n = 77; 50%), compared with non-U.S. sites (n = 7; 21%; p = 0.002). Non-U.S. sites had a significantly shorter time to first patient data entry after REDCap access: 7 (1–28) versus 3 days (1–6 d) (p = 0.02).

CONCLUSIONS:
In this Society of Critical Care Medicine global VIRUS: COVID-19 Registry, we identified considerable variability in time from IRB submission to first patient data entry with no significant differences by country or prior multicenter trial experience. However, there was a significant difference between US and non-U.S. sites in the time from REDCap access to first data entry.
Immune Adjuvant Therapy With Interleukin-7 in a Lymphopenic Patient With Aplastic Anemia and Mucormycosis
Authors: Crees Zachary D. , Patel Dilan A. , Dram Alexandra , Kim Miriam , Bern Michael D. , Eberly Allison R. , Augustin Kristan , Hotchkiss Richard S. , DiPersio John F. 
Published: October 2023

BACKGROUND:
We report the case of a patient with aplastic anemia and pancytopenia on immune-suppressive therapy who developed invasive pulmonary infection with mucormycosis and was treated with immune adjuvant therapy.

CASE SUMMARY:
Given the patient’s profound lymphopenia and progressive invasive mucor despite dual antifungal drug therapy, interleukin (IL)-7, a cytokine that induces lymphocyte activation and proliferation, was instituted and resulted in normalization of absolute lymphocyte counts and was temporally associated with clearance of fungal pathogens and resolution of clinical symptoms.

CONCLUSION:
Patients with life-threatening fungal infections are frequently immune suppressed and immune adjuvant therapies should be considered in patients who are not responding to antifungal drugs and source control. Well-designed, double-blind, placebo-controlled trials are needed to advance the field. Although a number of immune adjuvants may be beneficial in fungal sepsis, IL-7 is a particularly attractive immune adjuvant because of its broad immunologic effects on key immunologic pathways that mediate enhanced antifungal immune system activity.
Safety Summary of the Selective Cytopheretic Device: A Review of Safety Data Across Multiple Clinical Trials in ICU Patients With Acute Kidney Injury and Multiple Organ Failure
Authors: Humes H. David , Goldstein Stuart L. , Yessayan Lenar T. , Catanzaro David A. , Scribe Emily C. , Iyer Sai Prasad N. , Chung Kevin K. 
Published: October 2023

OBJECTIVES:
Acute kidney injury (AKI) requiring continuous kidney replacement therapy is a significant complication in ICU patients with mortality rates exceeding 50%. A dysregulated immune response can lead to systemic inflammation caused by hyperactivity of pro-inflammatory neutrophils and monocytes leading to tissue damage. The selective cytopheretic device (SCD) is an investigational medical device in a new class of cell-directed extracorporeal therapies distinct from cytokine adsorbers or filters, as it targets activated leukocytes. These leukocytes are the cellular sources driving this hyperinflammatory process. The objective of this report is to summarize the safety experience from clinical studies of the SCD in ICU patients with AKI or acute respiratory distress syndrome (ARDS) and multiple organ dysfunction (MOD).

DATA SOURCES AND STUDY SELECTION:
The studies included in this report represent all relevant trials of the SCD conducted in patients with AKI or ARDS and MOD. Adverse event data, clinical laboratory data and mortality rates were described and summarized in this report.

DATA EXTRACTION AND DATA SYNTHESIS:
Five clinical studies were included in this report, including four adult studies of AKI and/or ARDS and one pediatric AKI study, which involved 151 patients treated with the SCD in an ICU setting. Over 800 SCD sessions were deployed with an estimated 19,000 exposure hours with no device-related infections or attributable serious adverse events. Furthermore, there were no safety signals of leukopenia, thrombocytopenia, or other indications of immunodepletion or immunosuppression.

CONCLUSIONS:
The SCD has shown to be a promising extracorporeal therapy with promising clinical results and a favorable safety profile. These studies support that the SCD can be added as a therapeutic intervention in critically ill AKI patient populations with multiple organ failure without adding additional safety risks.
Delirium During Critical Illness and Subsequent Change of Treatment in Patients With Cancer: A Mediation Analysis*
Authors: Vizzacchi Bárbara A. , Dettino Aldo L. A. , Besen Bruno A. M. P. , Caruso Pedro , Nassar Antonio P. 
Published: October 2023

OBJECTIVES:
To assess whether delirium during ICU stay is associated with subsequent change in treatment of cancer after discharge.

DESIGN:
Retrospective cohort study.

SETTING:
A 50-bed ICU in a dedicated cancer center.

PATIENTS:
Patients greater than or equal to 18 years old with a previous proposal of cancer treatment (chemotherapy, target therapy, hormone therapy, immunotherapy, radiotherapy, oncologic surgery, and bone marrow transplantation).

INTERVENTIONS:
None.

MEASUREMENTS AND MAIN RESULTS:
We considered delirium present if Confusion Assessment Method for the ICU was positive. We assessed the association between delirium and modification of the treatment after discharge. We also performed a mediation analysis to assess both the direct and indirect (i.e., mediated by the development of functional dependence after discharge) of delirium on modification of cancer treatment and whether the modification of cancer treatment was associated with mortality at 1 year. We included 1,134 patients, of whom, 189 (16.7%) had delirium. Delirium was associated with the change in cancer treatment (adjusted odds ratio [OR], 3.80; 95% CI, 2.72–5.35). The association between delirium in ICU and change of treatment was both direct and mediated by the development of functional dependence after discharge. The proportion of the total effect of delirium on change of treatment mediated by the development of functional dependence after discharge was 33.0% (95% CI, 21.7–46.0%). Change in treatment was associated with increased mortality at 1 year (adjusted OR, 2.68; 95% CI, 2.01–3.60).

CONCLUSIONS:
Patients who had delirium during ICU stay had a higher rate of modification of cancer treatment after discharge. The effect of delirium on change in cancer treatment was only partially mediated by the development of functional dependence after discharge. Change in cancer treatment was associated with increased 1-year mortality.
Introducing DEPDOSE, a Tool to Calculate Dose Coefficients to Members of the Public for Radioactive Aerosols
Authors: Klumpp John , Bertelli Luiz , Eckerman Keith , Nelson Matthew , Wedell Liam , Deshler Mina , Brambilla Sara , Brown Michael 
Published: October 2023

Abstract
This paper presents DEPDOSE, an open-source computer application that combines the KDEP respiratory tract deposition fractions for inhaled aerosols with DC_PAK committed equivalent dose coefficients for a unit deposition in each region of the respiratory tract. DEPDOSE allows the user to rapidly produce tables of dose coefficients for workers and members of the public inhaling precisely defined, user-specified aerosols using the ICRP Publication 60 methodology. Combined with a plume dispersion modeling system, such as the Quick Urban & Industrial Complex (QUIC) Dispersion Modeling System, this makes it possible to predict radiation doses downstream from an accidental or intentional release of radioactive materials. For this work, a radioactive plume was calculated to members of the public downstream from a dirty bomb in Chicago. DEPDOSE is published under an open source license, and can be downloaded at https://github.com/lanl/DEPDOSE.
Risk Factors and Frequency of Examinations for Detecting Visual Field Deterioration in Patients with Newly Diagnosed Exfoliation Glaucoma in Sweden
Authors: Ayala Marcelo 
Published: October 2023

Précis:
The study identified risk factors for exfoliation glaucoma and recommended re-evaluating target intraocular pressure (IOP) after 5 visual fields to slow disease progression.

Purpose:
This study aimed to establish risk factors for exfoliation glaucoma and determine the earliest time points for estimating disease progression.

Patients:
A total of 96 patients with newly diagnosed exfoliation glaucoma were included. Included patients were required to perform at least 7 visual field tests within a 3-year period (±3 months). All patients were treated at inclusion.

Methods:
This was a nonrandomized, prospective cohort study. The predictors measured included IOP, mean deviation (MD), and visual field index (VFI). Progression was assessed using the rate of progression based on MD, VFI, and “Guided Progression Analysis.” Linear or logistic regression models were developed based on the variables studied. An analysis of variance was used to establish the earliest time point. At the earliest time point, the models were retested. The area under the receiver operating characteristic curve was calculated.

Results:
The general rate of progression of the cohort was −3.84 (±2.61) dB for the MD values and 9.66 (±6.25) % for the VFI values over 3 years. The IOP, MD, and VFI values at diagnosis were predictors of progression for both linear and logistic regression. Analysis of variance and post hoc Tukey test showed significant values at 24 months for MD and VFI. The area under the curve at 24 months showed significant values for MD and VFI.

Conclusions:
The predictors studied (IOP, MD, and VFI) showed moderate accuracy at baseline but excellent predictive capacity at 24 months postdiagnosis. Re-evaluating the target IOP at 24 months can effectively slow down disease progression.
Omidenepag Isopropyl in Latanoprost Low/Nonresponders With Primary Open Angle Glaucoma or Ocular Hypertension: A Phase 3, Nonrandomized, Two-Phase, Open-Label Study
Authors: Panarelli Joseph F. , Bowden Eileen C. , Tepedino Michael E. , Odani-Kawabata Noriko , Pei Zifan , McLaurin Eugene B. , Ropo Auli 
Published: October 2023

Précis:
This study demonstrates the efficacy and safety of once-daily 0.002% omidenepag isopropyl (OMDI) in patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) who do not respond or respond poorly to latanoprost.

Purpose:
The purpose of this study was to evaluate the intraocular pressure (IOP)-lowering efficacy and safety of OMDI in latanoprost low/nonresponders with POAG or OHT.

Materials and Methods:
Phase 3, nonrandomized, 2-phase, open-label, multicenter study (NCT03697811) in the United States. Key inclusion criteria included individuals aged 18 years or above, POAG or OHT diagnosis in both eyes, IOP ≥22 mm Hg in ≥1 eye, and ≤34 mm Hg in both eyes at all time points. Overall, 107 patients were enrolled; 104 completed treatment. Included a screening period (≤35-day washout period and 8-week latanoprost run-in period) and a 3-month treatment period comprising one drop of OMDI 0.002% once daily in both eyes. The primary study endpoint was changed from baseline in the mean diurnal (MD) IOP at month 3. Safety endpoints included incidence of adverse events, serious adverse events, and adverse drug reactions.

Results:
At baseline (visit 4), 75 (70.1%) patients had POAG, 32 (29.9%) had OHT, and 68 (63.6%) had prior use of prostaglandin/prostaglandin analogs (37.4% of whom used latanoprost). The mean (SD) baseline MD IOP was 23.34 mm Hg (2.12). The mean (SD) 3-month (visit 7) MD IOP change from baseline (following latanoprost run-in period and OMDI treatment period) was an additional decrease of 2.96 mm Hg (2.83) (P<0.0001). No significant safety issues were reported during OMDI treatment.

Conclusions:
These data demonstrate OMDI efficacy and safety in latanoprost low/nonresponders with POAG or OHT, suggesting OMDI is a treatment option in the patient population in this study.
Microscopic analysis of preinsertion cutting modalities on custom, flexible iris prostheses
Authors: Snyder Michael E. , Leone Adam R. , Werner Liliana , Bundogji Nour , Hawn Vivian 
Published: October 2023

Purpose:
To determine the induced edge effects of different clinically used device postmanufacture modification styles and modalities on custom iris implants.

Settings:
An academically affiliated multispecialty private practice group and an academic medical center.

Design:
Laboratory study.

Methods:
Sample custom iris prostheses were cut using patterns, blades, and surgical instruments described in the literature. The cut edges were evaluated with slitlamp microscopy, light microscopy, and scanning electron microscopy.

Results:
Disposable blades yielded smoother cuts than scissors. Trephine blade brand significantly affected the cut surface smoothness of the silicone matrix. Meshwork-embedded prostheses had some irregular sharp edges where the mesh fibers were cut with all modalities, although these were worse with scissors and one tested trephine brand compared with the other. Pseudoiridectomies and scissor cuts created sharp points and corners in the device periphery.

Conclusions:
Postmanufacture modifications of iris implants should be minimized. The cut margins of the fiber-free implants have fewer sharp edges and may be preferable for sulcus placement. In-the-bag device placement may mitigate clinical impact of sharp edges and corners. These practices may help to minimize inflammatory sequelae postimplantation.
Stress at Work and Well-being Before and During the COVID-19 Pandemic
Authors: Galliker Sibylle , Igic Ivana , Semmer Norbert K. , Elfering Achim 
Published: October 2023

Objective
The aim of the study is to analyze the development of conditions at work and health-related variables (notably exhaustion) in Switzerland longitudinally before and during the COVID-19 pandemic.

Methods
Questionnaire data were collected from a population-based sample of 1,553 employees in February 2020 and 1 year later. Health and well-being associated with (a) working conditions in general and (b) COVID-19–specific predictors such as worries about being infected and conditions for working at home were analyzed using analysis of (co)variance and multiple regression.

Results
Conditions at work and well-being were stable overall, even indicating slight improvements, notably for men compared with women. Both an index representing stressors and resources at work in general (Job Stress Index) and a COVID-19–related demand index showed consistent effects on health and the effect of COVID-19–related demands was stronger if the Job Stress Index deteriorated than when it improved.
The Acceptability, Feasibility, and Preliminary Effectiveness of a Courier HIV-Treatment Delivery and SMS Support Intervention for Young People Living With HIV in South Africa
Authors: Giovenco Danielle , Pettifor Audrey , Qayiya Yamkela , Jones Jeb , Bekker Linda-Gail 
Published: October 2023

Background:
Young people living with HIV (YPLWH) experience poorer rates of virological suppression compared with adults. Differentiated service delivery models for YPLWH are urgently needed to address this disparity.

Setting:
Participants were recruited from an HIV treatment clinic near Cape Town, South Africa.

Methods:
We conducted a longitudinal pilot study to examine the acceptability, feasibility, and preliminary effectiveness of a courier ART delivery and SMS support intervention to retain YPLWH (13–24 years) in care during COVID-19. YPLWH had the option to enroll in the courier service and were randomized 1:1 to receive adherence support via a weekly SMS. Modified Poisson regression was used to estimate the preliminary effectiveness of the courier intervention on viral suppression (HIV-1 RNA <200 copies/mL) at months 3 and 6.

Results:
Among 215 participants, 82% elected to enroll in the courier ART service at baseline, 41% reported receiving a delivery in the past 3 months at month 3, and 49% reported receiving a delivery in the past 3 months at month 6. Among those who received a delivery, most (91%–100%) rated the intervention as acceptable. Participants who reported receiving a delivery in the past 3 months at month 3 were 1.26 (95% CI: 1.05, 1.54) times as likely to have a suppressed viral load at month 3 and 1.21 (0.99, 1.48) times as likely at month 6, controlling for potential confounders.

Conclusions:
Findings reveal high uptake and acceptability of a courier ART delivery intervention among YPLWH and promising evidence for its effectiveness in increasing the probability of viral suppression. A fully powered trial is warranted.