Noninvasive Ventilation for Preoxygenation during Emergency Intubation.

BACKGROUND: Among critically ill adults undergoing tracheal intubation, hypoxemia increases the risk of cardiac arrest and death. The effect of preoxygenation with noninvasive ventilation, as compared with preoxygenation with an oxygen mask, on the incidence of hypoxemia during tracheal intubation is uncertain. METHODS: In a multicenter, randomized trial conducted at 24 emergency departments and intensive care units in the United States, we randomly assigned critically ill adults (age, ≥18 years) undergoing tracheal intubation to receive preoxygenation with either noninvasive ventilation or an oxygen mask. The primary outcome was hypoxemia during intubation, defined by an oxygen saturation of less than 85% during the interval between induction of anesthesia and 2 minutes after tracheal intubation. RESULTS: Among the 1301 patients enrolled, hypoxemia occurred in 57 of 624 patients (9.1%) in the noninvasive-ventilation group and in 118 of 637 patients (18.5%) in the oxygen-mask group (difference, -9.4 percentage points; 95% confidence interval [CI], -13.2 to -5.6; P<0.001). Cardiac arrest occurred in 1 patient (0.2%) in the noninvasive-ventilation group and in 7 patients (1.1%) in the oxygen-mask group (difference, -0.9 percentage points; 95% CI, -1.8 to -0.1). Aspiration occurred in 6 patients (0.9%) in the noninvasive-ventilation group and in 9 patients (1.4%) in the oxygen-mask group (difference, -0.4 percentage points; 95% CI, -1.6 to 0.7). CONCLUSIONS: Among critically ill adults undergoing tracheal intubation, preoxygenation with noninvasive ventilation resulted in a lower incidence of hypoxemia during intubation than preoxygenation with an oxygen mask. (Funded by the U.S. Department of Defense; PREOXI ClinicalTrials.gov number, NCT05267652.).

Comparing Intubation Rates in Patients Receiving Parenteral Olanzapine With and Without a Parenteral Benzodiazepine in the Emergency Department.

STUDY OBJECTIVE: United States prescribing information recommends against coadministration of injectable olanzapine with injectable benzodiazepines due to a risk of cardiorespiratory depression, whereas European prescribing information recommends the 2 drugs not be administered within 60 minutes of each other. In contrast, a recently published American College of Emergency Physicians clinical policy recommends injectable olanzapine and benzodiazepines be coadministered for treating severe agitation. We sought to compare injectable olanzapine with and without injectable benzodiazepines for evidence of cardiorespiratory depression. METHODS: We performed a retrospective study of patients in an urban emergency department from January 2017 through November 2019 who received parenteral olanzapine with or without parenteral benzodiazepines. We included patients receiving 2 total medication doses, either olanzapine+benzodiazepine or 2 doses of olanzapine, coadministered within 60 minutes. The primary outcome was tracheal intubation in the emergency department. Secondary outcomes included hypotension (systolic blood pressure less than 90 mmHg) and hypoxemia (SpO2 less than 90%). RESULTS: We identified 693 patients (median [alcohol]=210 mg/dL, median age=37 years [IQR 29 to 49]). In total, 549 received 2 doses of olanzapine, and 144 patients received olanzapine and a benzodiazepine. We found no difference in intubation rates between the olanzapine-only group (21/549, 3.8%) and the olanzapine+benzodiazepine group (5/144, 3.5%; difference=0.3%, 95% confidence interval -3.0% to 3.7%). Rates of hypoxemia (2% olanzapine-only and 3% olanzapine+benzodiazepine) and hypotension (9% both groups) also were not different between groups. CONCLUSION: We found no difference in cardiorespiratory depression between patients receiving only olanzapine versus olanzapine plus a benzodiazepine.

Conducted Electrical Weapon Fire Risk in the Presence of Supplemental Oxygen.

BACKGROUND: Conducted electrical weapons (CEWs) are nonlethal weapons used in tactical environments. Tactical EMS (TEMS) operators provide patient care in environments where CEWs are present. CEWs may produce a spark that can be a source of ignition. When supplemental oxygen is in use by a TEMS operator, the flammability risk from the CEW is unknown. METHODS: We measured oxygen levels over 20 minutes in an enclosed space with a supplemental oxygen source maximally flowing. Measurements were taken at various distances from the oxygen source to establish baseline concentrations. These concentrations were replicated within a plexiglass box where a CEW was activated to create a sparking arc between probes embedded in a fresh swine shoulder (with skin intact). Various flammable materials, typically found in a patient care setting were used as potential fuel sources. RESULTS: The highest oxygen levels were achieved directly at the source. At 15cm from the source, the maximum oxygen concentration was 31.5%. Within the box, ignition was only achieved at oxygen concentrations greater than 45% and only when human hair was present as fuel. No ignition was achieved at oxygen levels below this regardless of the tested fuel present. CONCLUSION: Ignition from a CEW is possible at supplemental oxygen levels greater than 45% when human hair is present. In an enclosed space, oxygen concentration levels of 45% are only present within 15cm of a flush rate oxygen source. The likelihood of CEW-caused ignition in such settings with supplemental oxygen in use is extremely low.

Flexible endoscopic intubation in emergency medicine: A mixed-methods needs assessment.

Objectives: This needs assessment aimed to improve understanding of flexible endoscopic intubation training and practice in emergency medicine (EM), providing insights to educators and practice leaders seeking to improve education and practices. Methods: We conducted a multicenter, mixed-methods needs assessment of emergency physicians (EPs) incorporating focus groups and a survey. Focus groups comprised community EPs, academic EPs, and resident EPs. We analyzed focus group transcripts using grounded theory, qualitatively describing EM endoscopic intubation. The qualitative analysis shaped our survey instrument, which we deployed in cross-sectional fashion. We report survey data with descriptive statistics. Results: Focus groups with 13 EPs identified three themes: indications for use of endoscopic intubation, factors impacting a physician's decision to endoscopically intubate, and attaining and maintaining endoscopic intubation competency. Of 257 surveyed EPs (33% response rate), 79% had received endoscopic intubation training during residency, though 82% had performed this procedure 10 or fewer times in their career. Despite 97% acknowledging the necessity of competency, only 23% felt highly confident in their ability to perform endoscopic intubation. Participants (93%) reported scarce opportunities to perform the procedure and identified factors believed to facilitate competency acquisition and maintenance, including opportunities to perform endoscopic intubation in practice (98%), local champions (93%), and performing nasopharyngoscopy (87%). Conclusions: While most EPs acknowledged the importance of competency in endoscopic intubation, they reported scarce procedural opportunities and commonly expressed low confidence. Further research is needed on this topic, and we propose avenues to enhance education and practices related to endoscopic intubation. These include development of robust procedural curricula, support of local champions, and incorporating nasopharyngoscopy into EM practice.

Feasibility and Safety of Oral Risperidone to Treat Prehospital Agitation.

OBJECTIVE: Agitation is a common prehospital problem and frequently presents without a clear etiology. Given the dynamic environment of the prehospital setting, there has historically been a varied approach to treating agitation with a heavy reliance on parenteral medications. Newer best practice guidelines recommend the incorporation of oral medications to treat patients experiencing agitation. Therefore, we evaluated the use of oral risperidone in a single system after a change in protocol occurred. METHODS: This was conducted as a retrospective chart review of an urban/suburban Emergency Medical Services system over the period of 8 months. The first day this medication was implemented throughout the service was included. Charts were included for selection if they included risperidone oral dissolving tablet (ODT) as a charted medication. The primary outcome was administration of additional medications to treat agitation. Exploratory outcome measures included acceptance of medication, documented injury to paramedics, documented injuries to patients, scene times, and adverse events that could possibly be linked to the medication. RESULTS: A total of 552 records were screened for inclusion. Risperidone was offered to 530 patients and accepted by 512 (96.6%). Of these 512 patients, the median age of included patients was 39 years old (IQR 29-52 years old) with a range of 18-89 years old. Rescue or additional medications for agitation were required in 9 (1.8%) cases. There were a total of 4 (0.8%) potential complications following administration of risperidone. There were no reported assaults with subsequent injuries to prehospital personnel or injuries sustained by patients reported in this study. CONCLUSIONS: Risperidone ODT was found to be a safe and effective medication to treat mild agitation in a large urban and suburban EMS system. The need for additional medications to treat agitation was rare, and there were no documented injuries to either patients or paramedics.

Early Physician Gestalt Versus Usual Screening Tools for the Prediction of Sepsis in Critically Ill Emergency Patients.

STUDY OBJECTIVE: Compare physician gestalt to existing screening tools for identifying sepsis in the initial minutes of presentation when time-sensitive treatments must be initiated. METHODS: This prospective observational study conducted with consecutive encounter sampling took place in the emergency department (ED) of an academic, urban, safety net hospital between September 2020 and May 2022. The study population included ED patients who were critically ill, excluding traumas, transfers, and self-evident diagnoses. Emergency physician gestalt was measured using a visual analog scale (VAS) from 0 to 100 at 15 and 60 minutes after patient arrival. The primary outcome was an explicit sepsis hospital discharge diagnosis. Clinical data were recorded for up to 3 hours to compare Systemic Inflammatory Response Syndrome (SIRS), Sequential Organ Failure Assessment (SOFA), quick SOFA (qSOFA), Modified Early Warning Score (MEWS), and a logistic regression machine learning model using Least Absolute Shrinkage and Selection Operator (LASSO) for variable selection. The screening tools were compared using receiver operating characteristic analysis and area under the curve calculation (AUC). RESULTS: A total of 2,484 patient-physician encounters involving 59 attending physicians were analyzed. Two hundred seventy-five patients (11%) received an explicit sepsis discharge diagnosis. When limited to available data at 15 minutes, initial VAS (AUC 0.90; 95% confidence interval [CI] 0.88, 0.92) outperformed all tools including LASSO (0.84; 95% CI 0.82 to 0.87), qSOFA (0.67; 95% CI 0.64 to 0.71), SIRS (0.67; 95% 0.64 to 0.70), SOFA (0.67; 95% CI 0.63 to 0.70), and MEWS (0.66; 95% CI 0.64 to 0.69). Expanding to data available at 60 minutes did not meaningfully change results. CONCLUSION: Among adults presenting to an ED with an undifferentiated critical illness, physician gestalt in the first 15 minutes of the encounter outperformed other screening methods in identifying sepsis.

The Pitfalls of Using Pop-Off Valves in Adult Emergency Airway.

BACKGROUND: Although common in pediatric airway equipment, positive-pressure relief ("pop-off") valves are also present on some adult resuscitator bags. These valves are designed to decrease barotrauma but, in doing so, limit the airway pressure provided during manual bag-assisted ventilation. In critically ill adult patients with high airway pressures, these valves can be detrimental and result in hypoventilation and subsequent hypoxemia. CASE REPORTS: In the 7 days after an unannounced introduction of new resuscitator bags with pop-off valves in the emergency department, there were 3 adult patients for whom an open pop-off valve resulted in hypoventilation and hypoxemia. These cases involved both medical and traumatic pathologies. In each case, there was a delay in discovering the change to a resuscitator bag equipped with a pop-off valve. Once the emergency physicians noticed the pop-off valve and closed them, there was significant improvement in ventilation and oxygenation. WHY SHOULD AN EMERGENCY PHYSICIAN BE AWARE OF THIS?: Hand-operated resuscitator bags are an essential tool for airway management. These cases represent two main lessons: changing airway equipment without notifying staff is dangerous, and an open pop-off valve will result in inadequate ventilation when patients have high airway pressures, without the tactile feedback of difficult bagging. Emergency physicians should be aware of equipment changes and know to disable the pop-off valve on resuscitator bags if they find them in their departments.

A Practical Solution for Preoxygenation in the Prehospital Setting: A Nonrebreather Mask with Flush Rate Oxygen.

OBJECTIVE: Prehospital clinicians need a practical means of providing adequate preoxygenation prior to intubation. A bag-valve-mask (BVM) can be used for preoxygenation in perfect conditions but is likely to fail in emergency settings. For this reason, many airway experts have moved away from using BVM for preoxygenation and instead suggest using a nonrebreather (NRB) mask with flush rate oxygen.Literature on preoxygenation has suggested that a NRB mask delivering flush rate oxygen (on a 15 L/min O2 regulator, maximum flow, ∼50 L/min) is noninferior to BVM at 15 L/min held with a tight seal. However, in the prehospital setting, where emergency airway management success varies, preoxygenation techniques have not been deeply explored. Our study seeks to determine whether preoxygenation can be optimally performed with NRB at flush rate oxygen. METHODS: We performed a crossover trial using healthy volunteers. Subjects underwent 3-min trials of preoxygenation with NRB mask at 25 L/min oxygen delivered from a portable tank, NRB at flush rate oxygen from a portable tank, NRB with flush rate oxygen from an onboard ambulance tank, and BVM with flush rate oxygen from an onboard ambulance tank. The primary outcome was the fraction of expired oxygen (FeO2). We compared the FeO2 of the BVM-flush to other study groups, using a noninferiority margin of 10%. RESULTS: We enrolled 30 subjects. Mean FeO2 values for NRB-25, NRB-flush ambulance, NRB-flush portable, and BVM-flush were 63% (95% confidence interval [CI] 58-68%), 74% (95%, CI 70-78%), 78% (95%, CI 74-83%), and 80% (95%, CI 75-84%), respectively. FeO2 values for NRB-flush on both portable tank and ambulance oxygen were noninferior to BVM-flush on the ambulance oxygen system (FeO2 differences of 1%, 95% CI -3% to 6%; and 6%, 95% CI 1-10%). FeO2 for the NRB-25 group was inferior to BVM-flush (FeO2 difference 16%, 95% CI 12-21%). CONCLUSIONS: Among healthy volunteers, flush rate preoxygenation using NRB masks is noninferior to BVM using either a portable oxygen tank or ambulance oxygen. This is significant because preoxygenation using NRB masks with flush rate oxygen presents a simpler alternative to the use of BVMs. Preoxygenation using NRB masks at 25 L/min from a portable tank is inferior to BVM at flush rate.

Factors Associated With Physical Restraint in an Urban Emergency Department.

STUDY OBJECTIVE: To determine what patient characteristics were associated with the application of physical restraints in our emergency department (ED). METHODS: This was a retrospective analysis of encounters in the ED of an urban, Level I academic trauma center. We included ED encounters of adult patients (aged ≥18 years) during a 5-year period starting in 2017. We evaluated the independent association of restraint application during an encounter using a generalized estimating equation model. RESULTS: There were 464,031 ED encounters during the time period from 162,244 unique patients, including 34,798 (7.5%) with restraint application, comprising 18,166 unique patients. Several variables were associated with an increased likelihood of restraint use during an encounter. The variable with the highest odds ratio was intoxication with drugs or alcohol (adjusted odds ratio [aOR] 8.29; 95% confidence interval (CI) 7.94 to 8.65). American Indian race was associated with increased odds of restraint application (aOR 1.42; 95% CI 1.31 to 1.54) compared to the reference value of White race. Black race (aOR 0.58; 95% CI 0.55 to 0.61) and Hispanic ethnicity (aOR 0.42; 95% CI 0.37 to 0.48) were associated with lower odds of restraint application. CONCLUSIONS: Drug and alcohol intoxication were most closely associated with restraint. Encounters in which the patient was American Indian had higher odds of restraint, but this study does not replicate prior findings regarding other racial disparities in restraint.

Awareness with paralysis and symptoms of post-traumatic stress disorder among mechanically ventilated emergency department survivors (ED-AWARENESS-2 Trial): study protocol for a pragmatic, multicenter, stepped wedge cluster randomized trial.

BACKGROUND: Awareness with paralysis (AWP) is memory recall during neuromuscular blockade (NMB) and can cause significant psychological harm. Decades of effort and rigorous trials have been conducted to prevent AWP in the operating room, where prevalence is 0.1-0.2%. By contrast, AWP in mechanically ventilated emergency department (ED) patients is common, with estimated prevalence of 3.3-7.4% among survivors given NMB. Longer-acting NMB use is a critical risk for AWP, and we have shown an association between ED rocuronium use and increased AWP prevalence. As NMB are given to more than 90% of ED patients during tracheal intubation, this trial provides a platform to test an intervention aimed at reducing AWP. The overall objective is to test the hypothesis that limiting ED rocuronium exposure will significantly reduce the proportion of patients experiencing AWP. METHODS: This is a pragmatic, stepped wedge cluster randomized trial conducted in five academic EDs, and will enroll 3090 patients. Per the design, all sites begin in a control phase, under observational conditions. At 6-month intervals, sites sequentially enter a 2-month transition phase, during which we will implement the multifaceted intervention, which will rely on use of nudges and defaults to change clinician decisions regarding ED NMB use. During the intervention phase, succinylcholine will be the default NMB over rocuronium. The primary outcome is AWP, assessed with the modified Brice questionnaire, adjudicated by three independent, blinded experts. The secondary outcome is the proportion of patients developing clinically significant symptoms of post-traumatic stress disorder at 30 and 180 days after hospital discharge. We will also assess for symptoms of depression and anxiety, and health-related quality of life. A generalized linear model, adjusted for time and cluster interactions, will be used to compare AWP in control versus intervention phases, analyzed by intention-to-treat. DISCUSSION: The ED-AWARENESS-2 Trial will be the first ED-based trial aimed at preventing AWP, a critical threat to patient safety. Results could shape clinical use of NMB in the ED and prevent more than 10,000 annual cases of AWP related to ED care. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT05534243 . Registered 06, September 2022.

The Effect of Ketamine Versus Etomidate for Rapid Sequence Intubation on Maximum Sequential Organ Failure Assessment Score: A Randomized Clinical Trial.

BACKGROUND: The use of induction agents for rapid sequence intubation (RSI) has been associated with hypotension in critically ill patients. Choice of induction agent may be important and the most commonly used agents are etomidate and ketamine. OBJECTIVE: This study aimed to compare the effects of a single dose of ketamine vs. etomidate for RSI on maximum Sequential Organ Failure Assessment (SOFA) score and incidence of hypotension. METHODS: This single-center, randomized, parallel-group trial compared the use of ketamine and etomidate for RSI in critically ill adult patients in the emergency department. The study was performed under Exception from Informed Consent. The primary outcome was the maximum SOFA score within 3 days of hospitalization. RESULTS: A total of 143 patients were enrolled in the trial, 70 in the ketamine group and 73 in the etomidate group. Maximum median SOFA score for the ketamine group was 6.5 (interquartile range [IQR] 5-9) vs. 7 (IQR 5-9) for etomidate with no significant difference (-0.2; 95% CI -1.4 to 1.1; p = 0.79). The incidence of post-intubation hypotension was 28% in the ketamine group vs. 26% in the etomidate group (difference 2%; 95% CI -13% to 17%). There were no significant differences in intensive care unit outcomes. Thirty-day mortality rate for the ketamine group was 11% (8 deaths) and for the etomidate group was 21% (15 deaths), which was not statistically different. CONCLUSIONS: There were no significant differences in maximum SOFA score or post-intubation hypotension between critically ill adults receiving ketamine vs. etomidate for RSI.

Extraglottic device use is rare during emergency airway management: A National Emergency Airway Registry (NEAR) study.

INTRODUCTION: Airway management is a critical component of the management of emergency department (ED) patients. The ED airway literature primarily focuses upon endotracheal intubation; relatively less is known about the ED use of extraglottic devices (EGDs). The goal of this study was to describe the frequency of use, success, and complications for EGDs among ED patients. METHODS: The National Emergency Airway Registry (NEAR) is a prospective, multi-center, observational registry. It captures data on all ED patients at participating sites requiring airway management. Intubating clinicians entered all data into an online system as soon as practical after each encounter. We conducted a secondary analysis of these data for all ED encounters in which EGD placement occurred. We used descriptive statistics to characterize these encounters. RESULTS: Of 19,071 patients undergoing intubation attempts, 56 (0.3%) underwent EGD placement. Of 25 participating sites, 13 reported no cases undergoing EGD placement; the median number of EGDs placed per site was 2 (interquartile range 1-2.5, range 1-31). Twenty-nine (54%) patients had either hypotension or hypoxia prior to the start of airway management. Clinicians reported anticipation of a difficult airway in 55% and at least one difficult airway characteristic in 93% of these patients. Forty-one encounters entailed placement of a laryngeal mask airway (LMA®) Fastrach™, 33 of whom underwent subsequent successful intubation through the EGD and 7 of whom underwent intubation by alternative methods. An additional 10 encounters utilized a standard LMA® device. Providers placed 34 (61%) EGDs during the first intubation attempt. Seventeen EGD patients (30%) experienced peri-procedure adverse events, including 14 (25%) experiencing hypoxemia. None of these patients expired due to failed airways. CONCLUSIONS: EGD use was rare in this multi-center ED registry. EGD occurred predominantly in patients with difficult airway characteristics with favorable airway management outcomes. Clinicians should consider this emergency airway device for patients with a suspected difficult airway.

Prophylactic Administration of Vasopressors Prior to Emergency Intubation in Critically Ill Patients: A Secondary Analysis of Two Multicenter Clinical Trials.

Hypotension affects approximately 40% of critically ill patients undergoing emergency intubation and is associated with an increased risk of death. The objective of this study was to examine the association between prophylactic vasopressor administration and the incidence of peri-intubation hypotension and other clinical outcomes. DESIGN: A secondary analysis of two multicenter randomized clinical trials. The clinical effect of prophylactic vasopressor administration was estimated using a one-to-one propensity-matched cohort of patients with and without prophylactic vasopressors. SETTING: Seven emergency departments and 17 ICUs across the United States. PATIENTS: One thousand seven hundred ninety-eight critically ill patients who underwent emergency intubation at the study sites between February 1, 2019, and May 24, 2021. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: The primary outcome was peri-intubation hypotension defined as a systolic blood pressure less than 90 mm Hg occurring between induction and 2 minutes after tracheal intubation. A total of 187 patients (10%) received prophylactic vasopressors prior to intubation. Compared with patients who did not receive prophylactic vasopressors, those who did were older, had higher Acute Physiology and Chronic Health Evaluation II scores, were more likely to have a diagnosis of sepsis, had lower pre-induction systolic blood pressures, and were more likely to be on continuous vasopressor infusions prior to intubation. In our propensity-matched cohort, prophylactic vasopressor administration was not associated with reduced risk of peri-intubation hypotension (41% vs 32%; p = 0.08) or change in systolic blood pressure from baseline (-12 vs -11 mm Hg; p = 0.66). CONCLUSIONS: The administration of prophylactic vasopressors was not associated with a lower incidence of peri-intubation hypotension in our propensity-matched analysis. To address potential residual confounding, randomized clinical trials should examine the effect of prophylactic vasopressor administration on peri-intubation outcomes.

Sedative Dose for Rapid Sequence Intubation and Postintubation Hypotension: Is There an Association?

STUDY OBJECTIVE: For patients with hemodynamic instability undergoing rapid sequence intubation, experts recommend reducing the sedative medication dose to minimize the risk of further hemodynamic deterioration. Scant data support this practice for etomidate and ketamine. We sought to determine if the dose of etomidate or ketamine was independently associated with postintubation hypotension. METHODS: We analyzed data from the National Emergency Airway Registry from January 2016 to December 2018. Patients aged 14 years or older were included if the first intubation attempt was facilitated with etomidate or ketamine. We used multivariable modeling to determine whether drug dose in milligrams per kilogram of patient weight was independently associated with postintubation hypotension (systolic blood pressure < 100 mm Hg). RESULTS: We analyzed 12,175 intubation encounters facilitated by etomidate and 1,849 facilitated by ketamine. The median drug doses were 0.28 mg/kg (interquartile range [IQR] 0.22 mg/kg to 0.32 mg/kg) for etomidate and 1.33 mg/kg (IQR 1 mg/kg to 1.8 mg/kg) for ketamine. Postintubation hypotension occurred in 1,976 patients (16.2%) who received etomidate and in 537 patients (29.0%) who received ketamine. In multivariable models, neither the etomidate dose (adjusted odds ratio [aOR] 0.95, 95% confidence interval [CI] 0.90 to 1.01) nor ketamine dose (aOR 0.97, 95% CI 0.81 to 1.17) was associated with postintubation hypotension. Results were similar in sensitivity analyses excluding patients with preintubation hypotension and including only patients intubated for shock. CONCLUSION: In this large registry of patients intubated after receiving either etomidate or ketamine, we observed no association between the weight-based sedative dose and postintubation hypotension.

Patiromer utility as an adjunct treatment in patients needing urgent hyperkalaemia management (PLATINUM): design of a multicentre, randomised, double-blind, placebo-controlled, parallel-group study.

INTRODUCTION: Hyperkalaemia is common, life-threatening and often requires emergency department (ED) management; however, no standardised ED treatment protocol exists. Common treatments transiently reducing serum potassium (K+) (including albuterol, glucose and insulin) may cause hypoglycaemia. We outline the design and rationale of the Patiromer Utility as an Adjunct Treatment in Patients Needing Urgent Hyperkalaemia Management (PLATINUM) study, which will be the largest ED randomised controlled hyperkalaemia trial ever performed, enabling assessment of a standardised approach to hyperkalaemia management, as well as establishing a new evaluation parameter (net clinical benefit) for acute hyperkalaemia treatment investigations. METHODS AND ANALYSIS: PLATINUM is a Phase 4, multicentre, randomised, double-blind, placebo-controlled study in participants who present to the ED at approximately 30 US sites. Approximately 300 adult participants with hyperkalaemia (K+ ≥5.8 mEq/L) will be enrolled. Participants will be randomised 1:1 to receive glucose (25 g intravenously <15 min before insulin), insulin (5 units intravenous bolus) and aerosolised albuterol (10 mg over 30 min), followed by a single oral dose of either 25.2 g patiromer or placebo, with a second dose of patiromer (8.4 g) or placebo after 24 hours. The primary endpoint is net clinical benefit, defined as the mean change in the number of additional interventions less the mean change in serum K+, at hour 6. Secondary endpoints are net clinical benefit at hour 4, proportion of participants without additional K+-related medical interventions, number of additional K+-related interventions and proportion of participants with sustained K+ reduction (K+ ≤5.5 mEq/L). Safety endpoints are the incidence of adverse events, and severity of changes in serum K+ and magnesium. ETHICS AND DISSEMINATION: A central Institutional Review Board (IRB) and Ethics Committee provided protocol approval (#20201569), with subsequent approval by local IRBs at each site, and participants will provide written consent. Primary results will be published in peer-reviewed manuscripts promptly following study completion. TRIAL REGISTRATION NUMBER: NCT04443608.

Video versus Direct Laryngoscopy for Tracheal Intubation of Critically Ill Adults.

BACKGROUND: Whether video laryngoscopy as compared with direct laryngoscopy increases the likelihood of successful tracheal intubation on the first attempt among critically ill adults is uncertain. METHODS: In a multicenter, randomized trial conducted at 17 emergency departments and intensive care units (ICUs), we randomly assigned critically ill adults undergoing tracheal intubation to the video-laryngoscope group or the direct-laryngoscope group. The primary outcome was successful intubation on the first attempt. The secondary outcome was the occurrence of severe complications during intubation; severe complications were defined as severe hypoxemia, severe hypotension, new or increased vasopressor use, cardiac arrest, or death. RESULTS: The trial was stopped for efficacy at the time of the single preplanned interim analysis. Among 1417 patients who were included in the final analysis (91.5% of whom underwent intubation that was performed by an emergency medicine resident or a critical care fellow), successful intubation on the first attempt occurred in 600 of the 705 patients (85.1%) in the video-laryngoscope group and in 504 of the 712 patients (70.8%) in the direct-laryngoscope group (absolute risk difference, 14.3 percentage points; 95% confidence interval [CI], 9.9 to 18.7; P<0.001). A total of 151 patients (21.4%) in the video-laryngoscope group and 149 patients (20.9%) in the direct-laryngoscope group had a severe complication during intubation (absolute risk difference, 0.5 percentage points; 95% CI, -3.9 to 4.9). Safety outcomes, including esophageal intubation, injury to the teeth, and aspiration, were similar in the two groups. CONCLUSIONS: Among critically ill adults undergoing tracheal intubation in an emergency department or ICU, the use of a video laryngoscope resulted in a higher incidence of successful intubation on the first attempt than the use of a direct laryngoscope. (Funded by the U.S. Department of Defense; DEVICE ClinicalTrials.gov number, NCT05239195.).

Laryngoscopy and Tracheal Intubation: Does Use of a Video Laryngoscope Facilitate Both Steps of the Procedure?

STUDY OBJECTIVE: To compare the effect of the use of a video laryngoscope versus a direct laryngoscope on each step of emergency intubation: laryngoscopy (step 1) and intubation of the trachea (step 2). METHODS: In a secondary observational analysis of data from 2 multicenter, randomized trials that enrolled critically ill adults undergoing tracheal intubation but did not control for laryngoscope type (video laryngoscope vs direct laryngoscope), we fit mixed-effects logistic regression models examining the 1) the association between laryngoscope type (video laryngoscope vs direct laryngoscope) and the Cormack-Lehane grade of view and 2) the interaction between grade of view, laryngoscope type (video laryngoscope vs direct laryngoscope), and the incidence of successful intubation on the first attempt. RESULTS: We analyzed 1,786 patients: 467 (26.2%) in the direct laryngoscope group and 1,319 (73.9%) in the video laryngoscope group. The use of a video laryngoscope was associated with an improved grade of view as compared with a direct laryngoscope (adjusted odds ratio for increasingly favorable grade of view 3.14, 95% confidence interval [CI] 2.47 to 3.99). Successful intubation on the first attempt occurred in 83.2% of patients in the video laryngoscope group and 72.2% of patients in the direct laryngoscope group (absolute difference 11.1%, 95% CI 6.5% to 15.6%). Video laryngoscope use modified the association between grade of view and successful intubation on the first attempt such that intubation on the first attempt was similar between video laryngoscope and direct laryngoscope at a grade 1 view and higher for video laryngoscope than direct laryngoscope at grade 2 to 4 views (P<.001 for interaction term). CONCLUSIONS: Among critically ill adults undergoing tracheal intubation, the use of a video laryngoscope was associated both with a better view of the vocal cords and with a higher probability of successfully intubating the trachea when the view of the vocal cords was incomplete in this observational analysis. However, a multicenter, randomized trial directly comparing the effect of a video laryngoscope with a direct laryngoscope on the grade of view, success, and complications is needed.

Defining Successful Intubation on the First Attempt Using Both Laryngoscope and Endotracheal Tube Insertions: A Secondary Analysis of Clinical Trial Data.

STUDY OBJECTIVES: Successful intubation on the first attempt has historically been defined as successful placement of an endotracheal tube (ETT) using a single laryngoscope insertion. More recent studies have defined successful placement of an ETT using a single laryngoscope insertion followed by a single ETT insertion. We sought to estimate the prevalence of first-attempt success using these 2 definitions and estimate their associations with the duration of intubation and serious complications. METHODS: We performed a secondary analysis of data from 2 multicenter randomized trials of critically ill adults being intubated in the emergency department or ICU. We calculated the percent difference in successful intubations on the first attempt, median difference in the duration of intubation, and percent difference in the development of serious complications by definition. RESULTS: The study population included 1,863 patients. Successful intubation on the first attempt decreased by 4.9% (95% confidence interval 2.5% to 7.3%) when defined as 1 laryngoscope insertion followed by 1 ETT insertion (81.2%) compared with when defined as only 1 laryngoscope insertion (86.0%). When successful intubation with 1 laryngoscope and 1 ETT insertion was compared with 1 laryngoscope and multiple ETT insertions, the median duration of intubation decreased by 35.0 seconds (95% confidence interval 8.9 to 61.1 seconds). CONCLUSION: Defining successful intubation on the first attempt as placement of an ETT in the trachea using 1 laryngoscope and 1 ETT insertion identifies attempts with the shortest apneic time.

Individualized Treatment Effects of Bougie versus Stylet for Tracheal Intubation in Critical Illness.

Rationale: A recent randomized trial found that using a bougie did not increase the incidence of successful intubation on first attempt in critically ill adults. The average effect of treatment in a trial population, however, may differ from effects for individuals. Objective: We hypothesized that application of a machine learning model to data from a clinical trial could estimate the effect of treatment (bougie vs. stylet) for individual patients based on their baseline characteristics ("individualized treatment effects"). Methods: This was a secondary analysis of the BOUGIE (Bougie or Stylet in Patients Undergoing Intubation Emergently) trial. A causal forest algorithm was used to model differences in outcome probabilities by randomized group assignment (bougie vs. stylet) for each patient in the first half of the trial (training cohort). This model was used to predict individualized treatment effects for each patient in the second half (validation cohort). Measurements and Main Results: Of 1,102 patients in the BOUGIE trial, 558 (50.6%) were the training cohort, and 544 (49.4%) were the validation cohort. In the validation cohort, individualized treatment effects predicted by the model significantly modified the effect of trial group assignment on the primary outcome (P value for interaction = 0.02; adjusted qini coefficient, 2.46). The most important model variables were difficult airway characteristics, body mass index, and Acute Physiology and Chronic Health Evaluation II score. Conclusions: In this hypothesis-generating secondary analysis of a randomized trial with no average treatment effect and no treatment effect in any prespecified subgroups, a causal forest machine learning algorithm identified patients who appeared to benefit from the use of a bougie over a stylet and from the use of a stylet over a bougie using complex interactions between baseline patient and operator characteristics.

Protocol and statistical analysis plan for the PREOXI trial of preoxygenation with noninvasive ventilation vs oxygen mask.

Background: Hypoxemia is a common and life-threatening complication during emergency tracheal intubation of critically ill adults. The administration of supplemental oxygen prior to the procedure ("preoxygenation") decreases the risk of hypoxemia during intubation. Research Question: Whether preoxygenation with noninvasive ventilation prevents hypoxemia during tracheal intubation of critically ill adults, compared to preoxygenation with oxygen mask, remains uncertain. Study Design and Methods: The PRagmatic trial Examining OXygenation prior to Intubation (PREOXI) is a prospective, multicenter, non-blinded randomized comparative effectiveness trial being conducted in 7 emergency departments and 17 intensive care units across the United States. The trial compares preoxygenation with noninvasive ventilation versus oxygen mask among 1300 critically ill adults undergoing emergency tracheal intubation. Eligible patients are randomized in a 1:1 ratio to receive either noninvasive ventilation or an oxygen mask prior to induction. The primary outcome is the incidence of hypoxemia, defined as a peripheral oxygen saturation <85% between induction and 2 minutes after intubation. The secondary outcome is the lowest oxygen saturation between induction and 2 minutes after intubation. Enrollment began on 10 March 2022 and is expected to conclude in 2023. Interpretation: The PREOXI trial will provide important data on the effectiveness of noninvasive ventilation and oxygen mask preoxygenation for the prevention of hypoxemia during emergency tracheal intubation. Specifying the protocol and statistical analysis plan prior to the conclusion of enrollment increases the rigor, reproducibility, and interpretability of the trial. Clinical trial registration number: NCT05267652.