Objective
Introduce novel methods and materials to limit microdroplet spread when performing transnasal aerosol generating procedures in the COVID‐19 era.
Methods
Prototypes of a negative pressure ...face shield (NPFS) were tested then used clinically to create a suction‐clearing negative pressure microenvironment with controlled access to the nose and mouth. Air pressure measurements within prototypes were followed by prospective evaluation of 30 consecutive patients treated with the device assessed through questionnaires and monitoring oximetry.
Results
The NPFS is a transparent acrylic barrier with two anterior instrumentation ports and a side port to which continuous suction is applied. It is positioned on a stand and employs a disposable antimicrobial wrap to secure an enclosure around the head. This assembly was successfully used to complete transnasal laryngoscopy in all 30 patients studied. Tolerance of the design was excellent, with postprocedure questionnaire identifying no shortness of breath (27/30), no claustrophobia (27/30), no pain (29/30), and no significant changes in pulse oximetry.
Conclusion
Diagnostic laryngoscopy was successfully performed in a negative pressure microenvironment created to limit dispersion of aerosols. Further application of the NPFS device is targeted for use with transnasal laryngeal laser and biopsy procedures to be followed by additional modification to enable intranasal and intraoral procedures in a similar protected environment.
Level of Evidence
Level 2b (Cohort Study).
Objective
To evaluate a negative pressure microenvironment designed to contain laser plume during flexible transnasal laryngoscopy.
Methods
The Negative Pressure Face Shield (NPFS) was previously ...reported as well tolerated with initial use on 30 patients. Diagnostic transnasal laryngoscopy was performed on an additional 108 consecutive patients who were evaluated by questionnaires and sequential pulse oximetry. Further study addressed operative transnasal potassium‐titanyl‐phosphate (KTP) laser laryngoscopy with biopsy done on four patients employing the NPFS.
Results
The previously described NPFS version 3 (v.3), a transparent acrylic barrier with two anterior instrumentation ports, was modified by repositioning the side suction port closer to the level of the nose and deepening the lateral sides, squaring off the lower projection. A post‐procedure questionnaire employing a 5‐point Likert scale ranging from no symptoms (rating of 1) to intolerable (rating of 5) identified excellent patient tolerance of the new design (v.4), among 22 patients evaluated and similar in the comparison to the 116 patients using version 3. Among the 138 patients analyzed, only one patient rated the experience as greater than “mild claustrophobia.” 100% of patients answered either “none” or “mild” to the pain and shortness of breath questions. The NPFS (v.4) was then successfully used in four patients for laser laryngoscopy with biopsy of laryngeal papilloma (3/4) and hemorrhagic polyp (1/4). Post‐procedure questionnaire identified no shortness of breath (4/4), no claustrophobia (4/4), no pain (4/4) and no significant changes in pulse oximetry during use.
Conclusion
Extensive experience in performing diagnostic laryngoscopy with the NPFS directed design changes leading to successful use for transnasal flexible laser laryngoscopy with biopsy in a negative pressure microenvironment.
Level of Evidence
Level 2b (Cohort Study).
Background
In‐office culture of the larynx using a flexible laryngoscope tip can help identify laryngeal pathogens in cases of laryngitis.
Objective
This retrospective case series aimed to ...investigate the feasibility of in‐office laryngoscope tip culture to identify laryngeal pathogens and help guide medical treatment.
Methods
This case series consists of 8 patients who underwent 11 in‐office laryngeal cultures using the tip of the flexible laryngoscope. Concurrent nasal cultures were performed on two patients to assess for possible nasal contamination of these laryngoscope tip cultures.
Results
Nine patients underwent laryngeal culture with laryngoscope tip in‐office, with two patients undergoing repeat swabs for a total of eleven swabs. Then, 8 of 11 swabs (73%) grew methicillin‐sensitive Staphylococcus aureus, while 1 of 11 (9.1%) swabs grew methicillin‐resistant S. aureus. Three of eleven swabs (27%) grew Candida species. Concurrent culture was performed of the contralateral nasal cavity in two patients to assess for the possibility of nasal contamination of laryngoscope tip cultures. Concurrent contralateral nasal cultures grew distinct pathogens compared to the laryngeal cultures, suggesting that nasal contamination did not occur.
Conclusion
In‐office laryngoscope tip culture allows safe identification of laryngeal pathogens in an ambulatory setting. In‐office laryngoscope tip culture can help guide medical treatment of laryngeal infections.
Level of Evidence
4
In‐office laryngeal culture can be performed safely using the tip of a flexible laryngoscope, helping guide medical treatment of laryngitis.
Objective:
The aim was to study the feasibility of performing office-based laryngeal procedures employing a flexible hollow steerable sheath placed contralateral to the nostril through which a ...standard flexible video endoscope is placed.
Methods:
The study design included simulation of transnasal endoscopic laryngeal procedures evaluating the use of a flexible steering sheath in laboratory and clinic settings. Transnasal laryngeal procedures were performed in an otolaryngology office setting employing an airway-management-trainer mannequin and then repeated in a human cadaver lab with standard transnasal flexible video laryngoscopy. Video documentation assessed use of a lever-manipulated deflecting ureteral access sheath with an inner diameter of 2.97 mm, an outer diameter of 4.95 mm, and a length of 45 cm. Simulated transnasal laryngoscopy procedures deployed devices through the deflecting sheath to mimic vocal fold needle injection, biopsy with forceps, balloon dilation, and laser treatment to identify strengths and shortcomings to the technology and technique.
Results:
Simulation was successful in appropriately directing instrumentation for all procedures tested. Shortcomings included limitations in steering capacity, greater length to the sheath than desirable for laryngeal procedures, and the need for additional assistants to perform procedures.
Conclusion:
Steering sheath technology is applicable to enhance in-office transnasal laryngoscopy procedures.
A descriptive analysis was given of the characteristics of the authors and citations of the articles in the journal Theological Studies from 1940-1995. Data was gathered on the institutional ...affiliation, geographic location, occupation, and gender and personal characteristics of the author. The citation characteristics were examined for the cited authors, date and age of the citations, format, language, place of publication, and journal titles. These characteristics were compared to the time-period before and after the Second Vatican Council in order to detect any changes that might have occurred in the characteristics after certain recommendations by the council were made to theologians. Subject dispersion of the literature was also analyzed. Lotka's Law of author productivity and Bradford's Law of title dispersion were also performed for this literature. The profile of the characteristics of the authors showed that the articles published by women and laypersons has increased since the recommendations of the council. The data had a good fit to Lotka's Law for the pre-Vatican II time period but not for the period after Vatican II. The data was a good fit to Bradford's Law for the predicted number of journals in the nucleus and Zone 2, but the observed number of journals in Zone 3 was higher than predicted for all time-periods. Subject dispersion of research from disciplines other than theology is low but citation to works from the fields of education, psychology, social sciences, and science has increased since Vatican II. The results of the analysis of the characteristics of the citations showed that there was no significant change in the age, format and languages used, or the geographic location of the publisher of the cited works after Vatican II. Citation characteristics showed that authors prefer research from monographs published in English and in U.S. locations for all time-periods. Research from the disciplines of education, psychology, science and the social sciences has increased, but authors preferred the use of theological sources for their research more than 70% of the time both before and after the council.
A descriptive analysis was given of the characteristics of the authors and citations of the articles in the journal Theological Studies from 1940–1995. Data was gathered on the institutional ...affiliation, geographic location, occupation, and gender and personal characteristics of the author. The citation characteristics were examined for the cited authors, date and age of the citations, format, language, place of publication, and journal titles. These characteristics were compared to the time-period before and after the Second Vatican Council in order to detect any changes that might have occurred in the characteristics after certain recommendations by the council were made to theologians. Subject dispersion of the literature was also analyzed. Lotka's Law of author productivity and Bradford's Law of title dispersion were also performed for this literature. The profile of the characteristics of the authors showed that the articles published by women and laypersons has increased since the recommendations of the council. The data had a good fit to Lotka's Law for the pre-Vatican II time period but not for the period after Vatican II. The data was a good fit to Bradford's Law for the predicted number of journals in the nucleus and Zone 2, but the observed number of journals in Zone 3 was higher than predicted for all time-periods. Subject dispersion of research from disciplines other than theology is low but citation to works from the fields of education, psychology, social sciences, and science has increased since Vatican II.
There is no standardized desensitization regimen for kidney transplant candidates. CD38, expressed by plasma cells, could be targeted for desensitization to deplete plasma cells producing ...alloantibodies and donor-specific antibodies. Few studies and case reports are available regarding the use of CD38 antibodies for desensitization in patients awaiting kidney transplant. This study shows that isatuximab, a CD38-targeting therapy, was well tolerated in kidney transplant candidates, with a durable decrease in anti-HLA antibodies and partial desensitization activity. The short treatment period and long follow-up of this study allowed for the understanding of the mechanism and timing for any antibody rebound. Isatuximab could be further investigated as an option for adjunct therapy to existing desensitization for patients on the kidney transplant waitlist.
Patients with calculated panel reactive antibody (cPRA) ≥80.00%, particularly those with cPRA ≥99.90%, are considered highly sensitized and underserved by the Kidney Allocation System. Desensitization removes circulating reactive antibodies and/or suppresses antibody production to increase the chances of a negative crossmatch. CD38 is expressed highly on plasma cells, thus is a potential target for desensitization.
This was an open-label single-arm phase 1/2 study investigating the safety, pharmacokinetics, and preliminary efficacy of isatuximab in patients awaiting kidney transplantation. There were two cohorts, cohorts A and B, which enrolled cPRA ≥99.90% and 80.00% to <99.90%, respectively.
Twenty-three patients (12 cohort A, 11 cohort B) received isatuximab 10 mg/kg weekly for 4 weeks then every 2 weeks for 8 weeks. Isatuximab was well tolerated with pharmacokinetic and pharmacodynamic profiles that indicated similar exposure to multiple myeloma trials. It resulted in decreases in CD38 + plasmablasts, plasma cells, and NK cells and significant reductions in HLA-specific IgG-producing memory B cells. Overall response rate, on the basis of a predefined composite desensitization end point, was 83.3% and 81.8% in cohorts A and B. Most responders had decreases in anti-HLA antibodies that were maintained for 26 weeks after the last dose. Overall, cPRA values were minimally affected, however, with only 9/23 patients (39%) having cPRA decreases to target levels. By study cutoff (median follow-up of 68 weeks), six patients received transplant offers, of which four were accepted.
In this open-label trial, isatuximab was well tolerated and resulted in a durable decrease in anti-HLA antibodies with partial desensitization activity.
NCT04294459 .
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