Educational suitability of new channel-type video-laryngoscope with AI-based glottis guidance system for novices wearing personal-protective-equipment.

ABSTRACT: The aim of this study was to determine which of 4 laryngoscopes, including A-LRYNGO, a newly developed channel-type video-laryngoscope with an embedded artificial intelligence-based glottis guidance system, is appropriate for tracheal intubation training in novice medical students wearing personal protective equipment (PPE).Thirty healthy senior medical school student volunteers were recruited. The participants underwent 2 tests with 4 laryngoscopes: Macintosh, McGrath, Pentax Airway-Scope and A-LRYNGO. The first test was conducted just after a lecture without any hands-on workshop. The second test was conducted after a one-on-one hands-on workshop. In each test, we measured the time required for tracheal intubation, intubation success rate, etc, and asked all participants to complete a short questionnaire.The time to completely insert the endotracheal tube with the Macintosh laryngoscope did not change significantly (P = .177), but the remaining outcomes significantly improved after the hands-on workshop (all P < .05). Despite being novice practitioners with no intubation experience and wearing PPE, the, 2 channel-type video-laryngoscopes were associated with good intubation-related performance before the hands-on workshop (all P < .001). A-LRYNGO's artificial intelligence-based glottis guidance system showed 93.1% accuracy, but 20.7% of trials were guided by the vocal folds.To prepare to manage the airway of critically ill patients during the coronavirus disease 2019 pandemic, a channel-type video-laryngoscope is appropriate for tracheal intubation training for novice practitioners wearing PPE.

Comparison of Vie Scope® and Macintosh laryngoscopes for intubation during resuscitation by paramedics wearing personal protective equipment.

BACKGROUND: Endotracheal intubation (ETI) is still the gold standard of airway management, but in cases of sudden cardiac arrest in patients with suspected SARS-CoV-2 infection, ETI is associated with risks for both the patient and the medical personnel. We hypothesized that the Vie Scope® is more useful for endotracheal intubation of suspected or confirmed COVID-19 cardiac arrest patients than the conventional laryngoscope with Macintosh blade when operators are wearing personal protective equipment (PPE). METHODS: Study was designed as a prospective, multicenter, randomized clinical trial performed by Emergency Medical Services in Poland. Patients with suspected or confirmed COVID-19 diagnosis who needed cardiopulmonary resuscitation in prehospital setting were included. Patients under 18 years old or with criteria predictive of impossible intubation under direct laryngoscopy, were excluded. Patients were randomly allocated 1:1 to Vie Scope® versus direct laryngoscopy with a Macintosh blade. Study groups were compared on success of intubation attempts, time to intubation, glottis visualization and number of optimization maneuvers. RESULTS: We enrolled 90 out-of-hospital cardiac arrest (OHCA) patients, aged 43-92 years. Compared to the VieScope® laryngoscope, use of the Macintosh laryngoscope required longer times for tracheal intubation with an estimated mean difference of -48 s (95%CI confidence interval [CI], -60.23, -35.77; p < 0.001). Moreover VieScope® improved first attempt success rate, 93.3% vs. 51.1% respectively (odds ratio [OR] = 13.39; 95%CI: 3.62, 49.58; p < 0.001). CONCLUSIONS: The use of the Vie Scope® laryngoscope in OHCA patients improved the first attempt success rate, and reduced intubation time compared to Macintosh laryngoscope in paramedics wearing PPE for against aerosol generating procedures. TRIAL REGISTRATION: ClinicalTrials registration number NCT04365608.

Intubation using VieScope vs. Video laryngoscopy in full personal protective equipment - a randomized, controlled simulation trial.

BACKGROUND: VieScope is a new type of laryngoscope, with a straight, transparent and illuminated blade, allowing for direct line of sight towards the larynx. In addition, VieScope is disposed of after single patient use, which can avoid cross-contaminations of contagious material. This has gained importance especially when treating patients with highly contagious infectious diseases, such as during the SARS-CoV2 pandemic. In this context, VieScope has not been evaluated yet in a clinical study. MATERIAL AND METHODS: This study compared intubation with VieScope to video-laryngoscopy (GlideScope) in normal and difficult airway in a standardized airway manikin in a randomized controlled simulation trial. Thirty-five medical specialists were asked to perform endotracheal intubation in full personal protective equipment (PPE). Primary endpoint was correct tube position. First-pass rate (i.e., success rate at the first attempt), time until intubation and time until first correct ventilation were registered as secondary endpoints. RESULTS: For correct tracheal tube placement, there was no significant difference between VieScope and GlideScope in normal and difficult airway conditions. VieScope had over 91% fist-pass success rate in normal airway setting. VieScope had a comparable success rate to GlideScope in difficult airway, but had a significantly longer time until intubation and time until ventilation. CONCLUSION: VieScope and GlideScope had high success rates in normal as well as in difficult airway. There was no unrecognized esophageal intubation in either group. Overall time for intubation was longer in the VieScope group, though in an acceptable range given in literature. Results from this simulation study suggest that VieScope may be an acceptable alternative for tracheal intubation in full PPE. TRIAL REGISTRATION: The study was registered at the German Clinical Trials Register www.drks.de (Registration date: 09/11/2020; TrialID: DRKS00023406 ).

Frequency of the requirement of inappropriate uncuffed tracheal tube size for pediatric patients: a retrospective observational analysis.

BACKGROUND: The insertion of inappropriately sized uncuffed endotracheal tubes (ETTs) with a tight seal or presence of air leakage may be necessary in children. This study aimed to analyze the frequency of the requirement of inappropriately sized uncuffed ETT insertion, air leakage after the ETT was replaced with one of a larger size, and factors associated with air leakage after ETT replacement. METHODS: Patients under 2 years of age who underwent oral surgery under general anesthesia with uncuffed ETTs between December 2013 and May 2015 were enrolled. The ETT size was selected at the discretion of the attending anesthesiologists. A leak test was performed after intubation. The ETT was replaced when considered necessary. Data regarding the leak pressure (PLeak) and inspiratory and expiratory tidal volumes were extracted from anesthesia records. We considered a PLeak of 10 < PLeak ≤ 30 cmH2O to be appropriate. The frequencies of the requirement of inappropriately sized ETTs, absence of leakage after ETT replacement, ETT size difference, and leak rate were calculated. A logistic regression was performed, with PLeak, leak rate, and size difference included as explanatory variables and presence of leakage after replacement as the outcome variable. RESULTS: Out of the 156 patients enrolled, 109 underwent ETT replacement, with the requirement of inappropriately sized ETTs being observed in 25 patients (23%). ETT replacement was performed in patients with PLeak ≤ 10 cmH2O; leakage was absent after replacement (PLeak < 30 cmH2O) in 52% of patients (25/48). In the multivariate logistic model, the leak rate before ETT replacement was significantly associated with the presence of leakage after replacement (p = 0.021). CONCLUSIONS: Inappropriately sized ETTs were inserted in approximately 23% of the patients. The leak rate may be useful to guide ETT replacement.

Drape to prevent disease transmission during endotracheal intubation.

Endotracheal intubation poses high risk of transmission of severe acute respiratory syndrome coronavirus 2 and other respiratory pathogens. We designed and here describe a protective drape that we believe will greatly reduce this risk. Unlike the intubation box that has been described prior, it is portable, disposable, and does not restrict operator dexterity. We have used it extensively and successfully during the height of the corona virus disease of 2019 outbreak.

Simulation of pediatric intubation using a low-cost videolaryngoscope in the setting of the COVID-19 pandemic. / Simulación de intubación pediátrica con videolaringoscopio de bajo costo en contexto de pandemia por COVID-19.

In patients with SARS-CoV-2 infection, endotracheal intubation is a procedure with a high risk for transmission. A videolaryngoscopy is a supplementary level of health care provider protection, but commercial videolaryngoscopes are expensive and not always available in pediatric intensive care units in Argentina. Our objective was to describe intubation practice using an infant head mannequin with a low-cost, handcrafted videolaryngoscope. Fifteen pediatricians with no prior experience using the device participated in an intubation practice in a head mannequin with a handcrafted videolaryngoscope. The average time for the first attempt was 116.4 seconds (95 % confidence interval [CI]: 84.8- 148.0) and, for the second one, 44.2 seconds (95 % CI: 27.7-60.6). Time decreased significantly for the second attempt (p: 0.0001). A successful intubation was achieved with the device in all attempts, and the procedure duration decreased with the second practice.

En pacientes con infección por SARS-CoV-2 la intubación endotraqueal es un procedimiento con riesgo elevado de contagio. La videolaringoscopia complementa la protección del profesional, pero los videolaringoscopios comerciales son caros y no siempre están disponibles en las terapias intensivas pediátricas argentinas. El objetivo fue describir la práctica de intubación en un modelo de cabeza de simulación de lactante con un videolaringoscopio artesanal de bajo costo. Quince pediatras sin experiencia previa con el dispositivo participaron de una práctica de intubación en una cabeza de simulación con un videolaringoscopio artesanal. El tiempo promedio del primer intento fue de 116,4 segundos (intervalo de confianza del 95 % [IC95 %]: 84,8-148,0) y, el del siguiente fue de 44,2 segundos (IC95 %: 27,7­60,6). El tiempo disminuyó de forma significativa en el segundo intento (p : 0,0001). El dispositivo permitió la intubación exitosa en todos los intentos acortando la duración del procedimiento en la segunda práctica.

Natural nasal-esophageal fiberscopy in the COVID-19 pandemic-preventing sneezing without anesthesia: a case report.

BACKGROUND: We are laryngologists. We observe natural phonatory and swallowing functions in clinical examinations with a trans-nasal laryngeal fiberscope (TNLF). Before each observation, we use epinephrine to enlarge and smooth the common nasal meatus (bottom of nostril) and then insert a wet swab inside the nose, as in taking a swab culture in the nasopharynx. During the current COVID-19 pandemic situation, this careful technique prevents any complications, including nasal bleeding, painfulness, and induced sneezing. Here, we introduce our routine to observe esophageal movement in swallowing in a natural (sitting) position without anesthesia. CASE PRESENTATION: The case was a 70-year-old female who complained that something was stuck in her esophagus; there was a strange sensation below the larynx and pharynx. After enlarging and smoothing the common nasal meatus, we inserted the TNLF (slim type ⌀2.9 mm fiberscope, VNL8-J10, PENTAX Medical, Tokyo, Japan.) in the normal way. We then observed the phonatory and swallowing movements of the vocal folds. As usual, to not interfere with natural movements, we used no anesthesia. We found no pathological condition in the pyriform sinus. We asked the patient to swallow the fiberscope. During the swallow, we pushed the TNLF and inserted the tip a bit deeper, which made the fiberscope easily enter the esophagus, like in the insertion of a nasogastric tube. We then asked the patient to swallow a sip of water or saliva to clear and enlarge the lumen of the esophagus. This made it possible to observe the esophagus easily without any air supply. With tone enhancement scan, the esophagus was found to be completely normal except for glycogenic acanthosis. CONCLUSIONS: The advantage of this examination is that it is easily able to perform without anesthesia and with the patient in sitting position. It is quick and minimally invasive, enabling observation the physiologically natural swallowing. It is also possible to observe without anesthesia down to the level of the esophagogastric junction using with a thin type flexible bronchoscope. In the future, gastric fiberscopes might be thinner, even with narrow band imaging (NBI) function. Before that time, physicians should remember to just insert along the bottom of the nose.

The aerosol box for intubation in coronavirus disease 2019 patients: an in-situ simulation crossover study.

The coronavirus disease 2019 pandemic has led to the manufacturing of novel devices to protect clinicians from the risk of transmission, including the aerosol box for use during tracheal intubation. We evaluated the impact of two aerosol boxes (an early-generation box and a latest-generation box) on intubations in patients with severe coronavirus disease 2019 with an in-situ simulation crossover study. The simulated process complied with the Safe Airway Society coronavirus disease 2019 airway management guidelines. The primary outcome was intubation time; secondary outcomes included first-pass success and breaches to personal protective equipment. All intubations were performed by specialist (consultant) anaesthetists and video recorded. Twelve anaesthetists performed 36 intubations. Intubation time with no aerosol box was significantly shorter than with the early-generation box (median (IQR [range]) 42.9 (32.9-46.9 [30.9-57.6])s vs. 82.1 (45.1-98.3 [30.8-180.0])s p = 0.002) and the latest-generation box (52.4 (43.1-70.3 [35.7-169.2])s, p = 0.008). No intubations without a box took more than 1 min, whereas 14 (58%) intubations with a box took over 1 min and 4 (17%) took over 2 min (including one failure). Without an aerosol box, all anaesthetists obtained first-pass success. With the early-generation and latest-generation boxes, 9 (75%) and 10 (83%) participants obtained first-pass success, respectively. One breach of personal protective equipment occurred using the early-generation box and seven breaches occurred using the latest-generation box. Aerosol boxes may increase intubation times and therefore expose patients to the risk of hypoxia. They may cause damage to conventional personal protective equipment and therefore place clinicians at risk of infection. Further research is required before these devices can be considered safe for clinical use.

Endotracheal intubation of COVID-19 patients by paramedics using a box barrier: A randomized crossover manikin study.

BACKGROUND: In the prehospital setting, endotracheal intubation (ETI) may be required to secure the coronavirus disease 2019 (COVID-19) patient airway. It has been suggested that the use of a protective barrier can reduce possible aerosol delivery from patients to clinicians during ETI. We sought to assess the performance of ETI by paramedics wearing personal protective equipment with and without the use of a box barrier. METHODS: A randomized, crossover simulation study was performed in a simulation laboratory. Study participants were 18 paramedics actively working in the clinical environment. Participants' performance of ETI via direct laryngoscopy (DL) with and without the use of a box barrier was assessed. The sequence of intubation was randomized to either BoxDL-first or DL-first. The primary outcome was the success rate of ETI on first-attempt. The secondary and tertiary outcomes were ETI success rates on three attempts and total intubation time, respectively. RESULTS: There were no differences between the DL group and the BoxDL group in one-attempt success rates (14/18 vs 12/18; P = 0.754), and in overall success rates (16/18 vs 14/18; P = 0.682). The mean (standard deviation) of the total intubation times for the DL group and the BoxDL group were 27.3 (19.7) seconds and 36.8 (26.2) seconds, respectively (P < 0.015). CONCLUSIONS: The findings of this pilot study suggest that paramedics wearing personal protective equipment can successfully perform ETI using a barrier box, but the intubation time may be prolonged. The applicability of these findings to the care of COVID-19 patients remain to be investigated.

Time to adapt in the pandemic era: a prospective randomized non -inferiority study comparing time to intubate with and without the barrier box.

BACKGROUND: The challenges posed by the spread of COVID-19 disease through aerosols have compelled anesthesiologists to modify their airway management practices. Devices such as barrier boxes are being considered as potential adjuncts to full PPE's to limit the aerosol spread. Usage of the barrier box raises concerns of delay in time to intubate (TTI). We designed our study to determine if using a barrier box with glidescope delays TTI within acceptable parameters to make relevant clinical conclusions. METHODS: Seventy-eight patients were enrolled in this prospective non-inferiority controlled trial and were randomly allocated to either group C (without the barrier box) or the study group BB (using barrier box). The primary measured endpoint is time to intubate (TTI), which is defined as time taken from loss of twitches confirmed with a peripheral nerve stimulator to confirmation of end-tidal CO 2. 15 s was used as non-inferiority margin for the purpose of the study. We used an unpaired two-sample single-sided t-test to test our non- inferiority hypothesis (H 0: Mean TTI diff ≥15 s, H A: Mean TTI diff < 15 s). Secondary endpoints include the number of attempts at intubation, lowest oxygen saturation during induction, and the need for bag-mask ventilation. RESULTS: Mean TTI in group C was 42 s (CI 19.2 to 64.8) vs. 52.1 s (CI 26.1 to 78) in group BB. The difference in mean TTI was 10.1 s (CI -∞ to 14.9). We rejected the null hypothesis and concluded with 95% confidence that the difference of the mean TTI between the groups is less than < 15 s (95% CI -∞ to 14.9,p = 0.0461). Our induction times were comparable (67.7 vs. 65.9 s).100% of our patients were intubated on the first attempt in both groups. None of our patients needed rescue breaths. CONCLUSIONS: We conclude that in patients with normal airway exam, scheduled for elective surgeries, our barrier box did not cause any clinically significant delay in TTI when airway manipulation is performed by well-trained providers. The study was retrospectively registered at clinicaltrials.gov (NCT04411056) on May 27, 2020.

An Aerosol Containment and Filtration Tent for Intubation During the COVID-19 Pandemic.

Background. Exposure to infectious droplets confers a high risk for infection transmission by the SARS-CoV-2 coronavirus. Aerosolizing procedures pose particular concern for increasing healthcare workers' (HCWs) risks of infection. Multiple creative personal protective equipment solutions have been utilized to minimize exposure to infectious particles; however, the overall benefit of many of these devices is limited by a number of factors. Methods. We designed an intubation tent consisting of a metal frame and a clear plastic sheet. The flexible walls of our tent offer increased maneuverability & access, although the efficacy in reducing risk of transmission to HCWs remained unclear. Using an atomizer, particle generator, and matchstick smoke, we simulated the generation of infectious respiratory droplets and aerosols and tested whether our device effectively decreased the concentration of these particles to which a provider might be exposed. Finally, we tested whether the addition of a vacuum fan fit with a high efficiency particulate air filter designed to evacuate contaminated air would influence particle concentrations inside and outside the tent. Results. Droplet dispersion tests with the tent in place showed that the simulated droplet distribution was limited to surfaces within the tent. Aerosol testing under a variety of circumstances consistently showed only a minor rise in particle concentration in the air outside the tent despite an initial peak of particle concentration during generation within. All testing demonstrated declining inside concentrations over time. Conclusions. Our simulations suggest our device has the potential to effectively decrease HCWs' exposure to infectious droplets and aerosolized viral particles.