Knowledge-based, computerized, patient clinical decision support system for perioperative pain, nausea and constipation management: a clinical feasibility study.

Opioid administration is particularly challenging in the perioperative period. Computerized-based Clinical Decision Support Systems (CDSS) are a promising innovation that might improve perioperative pain control. We report the development and feasibility validation of a knowledge-based CDSS aiming at optimizing the management of perioperative pain, postoperative nausea and vomiting (PONV), and laxative medications. This novel CDSS uses patient adaptive testing through a smartphone display, literature-based rules, and individual medical prescriptions to produce direct medical advice for the patient user. Our objective was to test the feasibility of the clinical use of our CDSS in the perioperative setting. This was a prospective single arm, single center, cohort study conducted in Strasbourg University Hospital. The primary outcome was the agreement between the recommendation provided by the experimental device and the recommendation provided by study personnel who interpreted the same care algorithm (control). Thirty-seven patients were included in the study of which 30 (81%) used the experimental device. Agreement between these two care recommendations (computer driven vs. clinician driven) was observed in 51 out 54 uses of the device (94.2% [95% CI 85.9-98.4%]). The agreement level had a probability of 86.6% to exceed the 90% clinically relevant agreement threshold. The knowledge-based, patient CDSS we developed was feasible at providing recommendations for the treatment of pain, PONV and constipation in a perioperative clinical setting.Trial registration number & date The study protocol was registered in ClinicalTrial.gov before enrollment began (NCT05707247 on January 26th, 2023).

The Acute Effect of Chamomile Intake on Blood Coagulation Tests in Healthy Volunteers: A Randomized Trial.

BACKGROUND: Chamomile administration may have desirable effects in the perioperative setting. Current practice, however, discourages perioperative chamomile use due to a theoretical increase in bleeding. Therefore, we evaluated if chamomile acutely (within 4 h of ingestion) prolongs coagulation assays. METHODS: Eight healthy volunteers were randomized to receive 2 interventions in a crossover design: (a) single dose of chamomile extract capsule (500 mg) and (b) single dose of chamomile tea (3 g in 150 mL water). Interventions were separated at least 3 days apart from each other. Blood was sampled pre-ingestion, 2 h post-ingestion, and 4 h post-ingestion for each intervention. The primary outcome was the maximal change in prothrombin time (PT) before vs after each intervention. Secondary outcomes included changes in international normalized ratio, activated partial thromboplastin time, thrombin time, reptilase time, and fibrinogen levels. RESULTS: All 8 subjects completed the study. The average pre-ingestion PT values for tea and capsules were 11.9 (1.1) s and 12.0 (0.9) s, respectively. Tea significantly increased the average maximum PT by 0.7 (0.2) s (P = 0.0078). Extract capsules increased the maximum PT by 0.3 (0.2) s (P = 0.06). Neither PT prolongation met the predefined 10% threshold for clinical significance. No significant changes in secondary outcomes were observed. CONCLUSIONS: Chamomile tea ingestion prolongs PT. However, the clinical significance of this is unclear at this time and warrants further investigation. ClinicalTrials.gov Registration Number: NCT05272475.

Effect of chamomile intake on blood coagulation tests in healthy volunteers: a randomized, placebo-controlled, crossover trial.

BACKGROUND: Chamomile is consumed worldwide for enjoyment and its potentially desirable properties. Widespread patient resource websites, however, discourage preoperative chamomile intake, lest bleeding could worsen. This precaution, though, stems largely from indirect evidence in one case report. To evaluate if chamomile ingestion impacts coagulation assays via coumarin-like substances, we designed a randomized, placebo-controlled, crossover study. MATERIALS AND METHODS: Healthy volunteers were randomized to three interventions in a cross-over-design spanning 5 weeks per subject. Interventions included 7-day consumption of chamomile tea (3 tea bags × 3 times daily = 9 tea bags daily), a chamomile extract capsule (3 times daily), or a placebo capsule (3 times daily). A 7-day washout period elapsed between intervention periods. The primary outcome was the change in prothrombin time (PT) before vs. after each intervention. Secondary outcomes included changes in the international normalized ratio (INR), activated partial thromboplastin time (aPTT), thrombin time (TT), reptilase time (RT), and fibrinogen (FG) surrounding each intervention. RESULTS: All 12 enrolled subjects were randomized and completed the study. The primary outcome of PT change (mean ± SD) was similar across interventions (chamomile tea = - 0.2 ± 0.4 s, extract capsule = - 0.2 ± 0.4 s, and placebo capsule = 0.1 ± 0.5 s; p = 0.34). INR change was 0 s (p = 0.07) for each intervention. The aPTT, TT, RT, and FG, did not change significantly across interventions (p = 0.8, p = 0.08, p = 0.8, and p = 0.2 respectively). CONCLUSIONS: Chamomile intake by tea or capsule does not prolong PT. These findings challenge the notion to avoid perioperative chamomile intake in patients not taking warfarin. TRIAL REGISTRATION: ClinicalTrials.gov, NCT05006378; Principal Investigator: Jonathon Schwartz, M.D.; Registered August 16, 2021.

Pictorial adaptation of the quality of recovery 15 scale and psychometric validation into a pediatric surgical population.

Patient reported outcomes measures (PROMS) are important endpoints to measure patient health status in the perioperative setting. However, there are no good tools to measure PROMS in the pediatric surgical population. Patients 7 to 17 years old undergoing surgery were included and followed up for 1 day after surgery (POD1). At POD1 the patients were asked to rate their overall postoperative recovery using a 100-mm visual analog scale (VAS). The primary outcome was the pediatric QoR-15 score on postoperative day 1 (POD1). 150 patients completed the study. The mean (SD) pediatric QoR-15F scores were 132.1 (14.1) and 111.0 (27.0), preoperatively and on POD1, respectively. Convergent validity confirmed with Pearson (r) correlation between the postoperative pediatric QoR-15F and the patient-rated global recovery assessment was 0.72 (95% confidence interval [0.63-0.79]; p < 10-16). Concerning reliability, internal consistency of the pediatric QoR-15 assessed by Cronbach's alpha was 0.90. The test-retest concordance correlation coefficient was 0.92; 95% CI [0.83-0.96]. Split-half alpha was 0.74. The pictorial pediatric version of the QoR-15F showed good validity, reliability, responsiveness, acceptability and feasibility. This PROMS should be considered for clinical care and research in the perioperative pediatric patient setting.Trial Registration: NCT04453410 on clinicaltrials.gov.

Randomized controlled trial of liberal vs. standard fasting instructions in percutaneous cardiac procedures.

BACKGROUND: Pre-procedural fasting to reduce aspiration risk is usual care prior to surgery requiring anesthesia. Prolonged fasting, however, can result in dehydration and may adversely affect patient experience and outcomes. Previous studies suggest that providing a supplemental beverage to patients undergoing cardiac and a variety of other surgical procedures improves patients' subjective assessment of thirst and hunger and potentially decreases the need for inotrope and vasopressor therapy. Less is known, however, about the effects of ad libitum clear liquids up to 2 h prior to surgery. METHODS: Adult patients undergoing transcatheter aortic valve replacement (TAVR) or arrhythmia ablation were randomized (1:1) to ad libitum clear liquids up to 2 h prior to their procedure vs. nil per os (NPO) after midnight (control group, usual care). The primary endpoint was a composite satisfaction score that included patient-reported thirst, hunger, headache, nausea, lightheadedness, and anxiousness prior to surgery. The incidence of case-delay was recorded. Intraoperative vasopressor administration, changes in creatinine, anti-emetic use, and hospital length of stay (LOS) were recorded. Safety endpoints including aspiration were assessed. RESULTS: A total of 200 patients were randomized and 181 patients were included in the final analysis. Overall, 92% of patients were ASA class III or IV and 23% of patients had NYHA class III or IV symptoms. Groups were well balanced with no significant differences in age, sex or baseline cardiac or renal disease. The composite satisfaction score (primary endpoint) was not significantly different between groups (Ad libitum median = 12, IQR = [6, 17], vs Standard NPO median = 10, IQR = [5, 15], [95% CI = [-1, 4]). No significant differences between the two groups were observed in any of the individual survey questions (thirst, hunger, headache, nausea, lightheadedness, anxiousness). No significant differences between groups were observed for intra-operative vasopressor use, changes in creatinine, rescue anti-emetic use or hospital LOS. There were no case delays attributed to the intervention. There were no cases of suspected aspiration. CONCLUSION: No adverse events or case delays were observed in the ad libitum clears group. No significant benefit, however, was observed in patient satisfaction or any of the pre-specified secondary endpoints in patients randomized to ad libitum clear liquids up to 2 h prior to their procedure. TRIAL REGISTRATION: NCT04079543.

Ability of the integrated pulmonary index to predict impending respiratory events in the early postoperative period.

BACKGROUND: In the early postoperative period, respiratory compromise is a significant problem. Standard-of-care monitoring includes respiratory rate (RR) and pulse oximetry, which are helpful; however, low SpO2 is often a late sign during decompensation. The FDA-approved Capnostream-20p monitor records four variables (SpO2, RR, End-tidal CO2, heart rate), which are combined by fuzzy logic into a single, unit-less value (range 1-10) called the integrated pulmonary index (IPI). No published studies have assessed the performance of a low IPI to predict impending respiratory events. METHODS: In this investigator-initiated study, adult patients undergoing general anesthesia were monitored with the Capnostream-20p monitor for up to 2 h during their recovery room stay. The study coordinator, who along with clinicians, was blinded to IPI values, recorded the time of any respiratory event, defined a priori as any one of eight respiratory-related interventions/conditions. The primary sensitivity endpoint (early detection success) was defined as at least 80% of events predicted by at least 2 consecutive low IPI (≤ 7) values within 2-15 min before an event occurred. Late detection was defined as low IPI values occurring with 2 min prior to or 2 min after the event occurred. DISCUSSION: Of 358 patients, ≥ 1 respiratory event occurred in 183 (51.1%) patients. Of 802 total events, 606 were detected early (within 2-15 min prior to the event), and 653 were detected either early or late. Therefore, the sensitivity for early detection was 75.6% (95% confidence interval [CI]: 72.6-78.5%), which differed significantly from the 80% sensitivity goal by 4.4% (p = 0.0016). Sensitivity for total success (early or late) was 81.4% (95% CI: 78.7-84.1%), which was significantly different from the 90% on time sensitivity goal by 8.6% (p < 0.0001). CONCLUSIONS: A low IPI was 75.6% sensitive for early detection (within 2-15 min) prior to respiratory events but did not achieve our preset threshold of 80% for success.

Evaluation of a novel platform for placement confirmation of enteral feeding tubes in adults.

OBJECTIVE: The aim of this study was to validate the ability of a novel, impedance-based platform for nasogastric feeding tube (FT) insertion to correctly predict intragastric FT placement in healthy individuals with and without acid suppression medication. METHODS: Ten patients underwent successive placement of 8, 10, and 12 French FTs with the final intragastric position predicted using an impedance-based algorithm and verified with an abdominal x-ray. Study procedures were repeated after patients received a proton pump inhibitor (PPI) for 3 d. RESULTS: Nasogastric FTs with embedded electrodes spaced along the distal 31 cm of the tubes were placed with the final insertion depth determined by an algorithm integrating impedance and other physiologic parameters. Sixty FT (30 pre-PPI and 30 post-PPI) insertions were performed. The algorithm-predicted location was confirmed as intragastric in all insertions by post-placement abdominal x-ray. For all tube sizes and those with and without PPIs, the impedance at electrodes within the esophagus was significantly higher than at electrodes in the stomach (P < 0.01). As a secondary objective to assess the use of gastric aspirate pH to determine location, gastric aspirate could only be obtained in 30% of insertions. The mean gastric pH was 6.9 (SD 0.6) in patients taking PPIs. CONCLUSIONS: A novel platform for real-time assistance with nasogastric FT placement confirmation correctly determined intragastric FT location as confirmed by abdominal x-ray (standard of care) in all 60 insertions. Gastric pH measurements were difficult to obtain and unreliable for intragastric FT placement confirmation in patients taking acid suppression medication.

Effect of surgical delay on 30-day mortality in patients receiving direct oral anticoagulants and admitted for hip fracture.

BACKGROUND: Early hip fracture surgery is recommended to decrease mortality, however the impact of a delay in surgery due to previous treatment with direct oral anticoagulants (DOA) is unknown. Our objective was to determine if early surgery, defined as surgery within 48 h of hospital admission is associated with decreased postoperative mortality. We tested the hypothesis that early surgery was beneficial with regard for mortality in patients treated with direct oral anticoagulants. METHODS: Retrospective cohort study in a French University Hospital including patient admitted for Hip fracture. The main exposure was wait time for surgery defined as the total time, in hours, between hospital admission and surgery. The main outcome was mortality within 30 days after hip fracture surgery. RESULTS: In 3429 patients, the overall 30-day mortality was 4.1% (95% CI 3.5%; 4.9%). In DOA + patients, the 30-day mortality rates in the early and delayed surgery groups were 1.2% and 5.9%, respectively, with estimated risk difference of -4.4 (with a 2% probability of this difference is > 0). In the DOA + group, early surgery tended to be associated with a higher percentage receiving red-blood cells (64.6% vs 54.8%, respectively, estimated risk difference of 9.9% with a 93% probability of this difference is > 0) and lower risk of pneumonia (1.2% vs 8.2%, respectively; estimated difference of -6.7% with 0.3% probability of superiority). CONCLUSION: Early hip fracture surgery was associated with improved survival in patients previously treated with DOAs.

General Anesthetics in CAncer REsection Surgery (GA-CARES) randomized multicenter trial of propofol vs volatile inhalational anesthesia: protocol description.

BACKGROUND: Studies indicate that patients can be "seeded" with their own cancer cells during oncologic surgery and that the immune response to these circulating cancer cells might influence the risk of cancer recurrence. Preliminary data from animal studies and some retrospective analyses suggest that anesthetic technique might affect the immune response during surgery and hence the risk of cancer recurrence. In 2015, experts called for prospective scientific inquiry into whether anesthetic technique used in cancer resection surgeries affects cancer-related outcomes such as recurrence and mortality. Therefore, we designed a pragmatic phase 3 multicenter randomized controlled trial (RCT) called General Anesthetics in Cancer Resection (GA-CARES). METHODS: After clinical trial registration and institutional review board approval, patients providing written informed consent were enrolled at five sites in New York (NY) State. Eligible patients were adults with known or suspected cancer undergoing one of eight oncologic surgeries having a high risk of cancer recurrence. Exclusion criteria included known or suspected history of malignant hyperthermia or hypersensitivity to either propofol or volatile anesthetic agents. Patients were randomized (1:1) stratified by center and surgery type using REDCap to receive either propofol or volatile agent for maintenance of general anesthesia (GA). This pragmatic trial, which seeks to assess the potential impact of anesthetic type in "real world practice", did not standardize any aspect of patient care. However, potential confounders, e.g., use of neuroaxial anesthesia, were recorded to confirm the balance between study arms. Assuming a 5% absolute difference in 2-year overall survival rates (85% vs 90%) between study arms (primary endpoint, minimum 2-year follow-up), power using a two-sided log-rank test with type I error of 0.05 (no planned interim analyses) was calculated to be 97.4% based on a target enrollment of 1800 subjects. Data sources include the National Death Index (gold standard for vital status in the USA), NY Cancer Registry, and electronic harvesting of data from electronic medical records (EMR), with minimal manual data abstraction/data entry. DISCUSSION: Enrollment has been completed (n = 1804) and the study is in the follow-up phase. This unfunded, pragmatic trial, uses a novel approach for data collection focusing on electronic sources. TRIAL REGISTRATION: Registered (NCT03034096) on January 27, 2017, prior to consent of the first patient on January 31, 2017.

Perioperative Quality Initiative and Enhanced Recovery After Surgery-Cardiac Society Consensus Statement on the Management of Preoperative Anemia and Iron Deficiency in Adult Cardiac Surgery Patients.

Preoperative anemia is common in patients presenting for cardiac surgery, with a prevalence of approximately 1 in 4, and has been associated with worse outcomes including increased risk of blood transfusion, kidney injury, stroke, infection, and death. Iron deficiency, a major cause of anemia, has also been shown to have an association with worse outcomes in patients undergoing cardiac surgery, even in the absence of anemia. Although recent guidelines have supported diagnosing and treating anemia and iron deficiency before elective surgery, details on when and how to screen and treat remain unclear. The Eighth Perioperative Quality Initiative (POQI 8) consensus conference, in conjunction with the Enhanced Recovery after Surgery-Cardiac Surgery Society, brought together an international, multidisciplinary team of experts to review and evaluate the literature on screening, diagnosing, and managing preoperative anemia and iron deficiency in patients undergoing cardiac surgery, and to provide evidence-based recommendations in accordance with Grading of Recommendations, Assessment, Development and Evaluation (GRADE) criteria for evaluating biomedical literature.

A Survey of Dentist Anesthesiologists on Preoperative Intramuscular Sedation.

OBJECTIVE: The induction of general anesthesia for children and patients with special needs frequently requires preinduction sedation, especially when anxiety and agitation lead to violent or combative behavior. In these situations, preoperative intramuscular (IM) sedation may facilitate patient transfer, intravenous cannulation, and/or mask induction. This survey aimed to capture data regarding the current preoperative IM sedation practices of dentist anesthesiologists. METHODS: An electronic survey was distributed in 2020 to all members of the American Society of Dentist Anesthesiologists regarding the administration of preoperative IM sedation. It included questions about the demographics of respondents and their patients who require IM sedation, the most common drug regimens used, decision-making criteria regarding ketamine dosing, the intended level of sedation, sequence of anesthetic management following IM sedation, and observed outcomes. RESULTS: A total of 193 responses (43%) were received; of those, 162 reported using preoperative IM sedation. Ketamine was included in 98.7% of reported IM drug regimens. The most common IM sedation regimen was combined ketamine and midazolam (median 2.5 mg/kg and 0.1 mg/kg, respectively). Of the respondents who use preoperative IM sedation, 87% reported using the same drug regimen in at least 80% of cases. CONCLUSION: The most frequently reported drug regimen used by dentist anesthesiologists in North America for preoperative IM sedation was a combination of ketamine and midazolam.

Thrombin Generation in Cardiac Versus Noncardiac Surgical Cohorts.

BACKGROUND: Bleeding can be a significant problem after cardiac surgery. As a result, venous thromboembolism (VTE) or anticoagulation or both following mechanical valve implantation are often delayed in these patients. The calibrated automated thrombin (CAT) generation assay has become the gold standard to evaluate thrombin generation, a critical step in clot formation independent of other hemostatic processes (eg, platelet activation, fibrin cross-linking, and fibrinolysis), and is increasingly used to examine thrombotic and hemorrhagic outcomes. No study has currently used this assay to compare the thrombin generation profiles of cardiac surgical patients to noncardiac surgical patients. We hypothesize that noncardiac patients may be less prone to postoperative changes in thrombin generation. METHODS: A prospective, observational, cohort study was undertaken using blood samples from 50 cardiac and 50 noncardiac surgical patients preoperatively, immediately postoperatively, and on postoperative days 1 to 4. Platelet-poor plasma samples were obtained from patients preoperatively, on arrival to the postanesthesia care unit (PACU) or intensive care unit (ICU), and daily on postoperative days 1 to 4 if patients remained inpatient. Samples were evaluated for CAT measurements. Patient and surgical procedure characteristics were obtained from the electronic medical record. RESULTS: The primary outcome variable, median endogenous thrombin potential (ETP), measured in nanomolar × minutes (nM × min), was decreased 100% in cardiac surgical versus 2% in noncardiac patients (P < .001). All parameters of thrombin generation were similarly depressed. Cardiac (versus noncardiac) surgical type was associated with -76.5% difference of percent change in ETP on multivariable regression analysis (95% confidence interval [CI], -87.4 to -65.5; P value <.001). CONCLUSIONS: Cardiac surgical patients exhibit a profound decrease in thrombin generation postoperatively compared with noncardiac surgical patients evaluated by this study. Hemodilution and coagulation factor depletion likely contribute to this decreased thrombin generation after cardiac surgery.

Predictors and Impact of Low Diastolic Blood Pressure and Widened Pulse Pressure Following Transcatheter Aortic Valve Replacement.

BACKGROUND: The association between post-operative diastolic blood pressure (DBP) and pulse pressure (PP) with outcomes following transcatheter aortic valve replacement (TAVR) remains unclear. We sought to assess the prevalence, predictors, and impact of post-operative DBP and PP on presence of post-procedural aortic insufficiency (AI) and mortality in adults undergoing TAVR. METHODS: The study population included 194 patients who underwent TAVR from 2016 to 2017 at an academic tertiary medical center, of which 176 had invasive arterial pressures available postoperatively. Low DBP and widened PP were defined as ≤40 mmHg and ≥80 mmHg respectively on invasive arterial line on post-operative day 1. Clinical outcomes of interest included post-procedural AI and 1-year all-cause mortality. RESULTS: Post-operative low DBP and widened PP were noted in 32.4% and 58.5% of the study population. No significant association between post-operative AI and low DBP (p = 0.82) or widened PP (p = 0.32) was noted. There was a trend toward higher rates of mortality in patients with low DBP (19.3% vs 9.2%, p = 0.06) but no difference in mortality in patients with widened PP (10.7% vs 15.1%, p = 0.39) or those with ≥1+ post-procedural AI (16.7% vs 10.7%, p = 0.32). In multivariable analysis, low DBP was associated with a trend toward higher rates of 1-year mortality [odds ratio (OR) 2.43, 95% confidence interval (CI) 0.97-6.11, p = 0.06]. When excluding patients with a post-operative invasive systolic blood pressure < 80 mmHg, low DBP was associated with significantly higher risk-adjusted mortality at 1 year [OR 2.75, 95% CI (1.07-7.07), p = 0.04]. CONCLUSIONS: In this contemporary study of adults undergoing TAVR, low DBP and widened PP were widely prevalent post TAVR. Low DBP was associated with a trend toward higher rates of 1-year mortality but not with post-procedural AI.

Comparing Email, SMS, and Concurrent Mixed Modes Approaches to Capture Quality of Recovery in the Perioperative Period: Retrospective Longitudinal Cohort Study.

BACKGROUND: As patients are discharged from the hospital more quickly, the ability to monitor patient recovery between hospital discharge and the first follow-up clinic visit is becoming increasingly important. Despite substantial increase in both internet use and smartphone ownership over the past 5 years, clinicians have been slow to embrace the use of these devices to capture patient recovery information in the period between hospital discharge and the first clinical follow-up appointment. OBJECTIVE: This study aims to investigate the generalizability of using a web-based platform to capture patient recovery in a broad surgical patient population and compare response rates for 3 different web-based strategies for delivering recovery surveys over the perioperative period: email, SMS text messaging, and a concurrent mixed approach of using both email and SMS text messaging. METHODS: Patients undergoing surgeries managed with an enhanced recovery after surgery pathway were asked to participate in a web-based quality assurance monitoring program at the time of their preoperative surgery appointment. Different follow-up methods were implemented over 3 sequential phases. Patients received Health Insurance Portability and Accountability Act-compliant web-based survey links via email (phase 1), SMS text messaging (phase 2), or concurrently using both email and SMS text messaging (phase 3) using REDCap and Twilio software. Recovery assessments using the established Quality of Recovery-9 instrument were performed 4 days before surgery and at 7 and 30 days postoperatively. Generalizability of the web-based system was examined by comparing characteristics of those who participated versus those who did not. Differences in response rates by the web-based collection method were analyzed using adjusted models. RESULTS: A total of 615 patients were asked to participate, with 526 (85.5%) opting for the follow-up program. Those who opted in were younger, slightly healthier, and more likely to be in a partnership. The concurrent mixed modes method was the most successful for obtaining responses at each time point compared with text or email alone (pre: 119/160, 74.4% vs 116/173, 67.1% vs 56/130, 43.1%, P<.001; 7 days: 115/172, 66.9% vs 82/164, 50.0% vs 59/126, 46.8%, P=.001; 30 days: 152/234, 65.0% vs 52/105, 49.5% vs 53/123, 43.1%, P=.001, respectively). In the adjusted model, the concurrent mixed modes method significantly predicted response compared with using email alone (odds ratio 3.4; P<.001) and SMS text messaging alone (odds ratio 1.9; P<.001). Additional significant predictors of response were race, partnership, and time. CONCLUSIONS: For internet users and smartphone owners, electronic capture of recovery surveys appear to be possible through this mechanism. Discrepancies in both inclusion and response rates still exist among certain subgroups of patients, but the concurrent approach of using both email and text messages was the most effective approach to reach the largest number of patients across all subgroups.

A U.S. survey of pre-operative carbohydrate-containing beverage use in colorectal enhanced recovery after surgery (ERAS) programs.

BACKGROUND: Carbohydrate-containing drinks (CCD) are administered preoperatively in most enhanced recovery after surgery (ERAS) programs. It is not known which types of CCDs are used, e.g., simple vs. complex carbohydrate, and if the choice of drink differs in patients with diabetes. METHODS: A national survey was performed to characterize the use of preoperative CCDs within the context of adult colorectal ERAS programs. The survey had questions regarding the use of preoperative CCDs, the types of beverages used, and the timing of beverage administration. The survey was administered electronically to members of the American Society for Enhanced Recovery (ASER) and manually to participants at the 2018 Perioperative Quality and Enhanced Recovery Conference in San Francisco, CA. RESULTS: Responses were received from 78 unique hospitals with a colorectal ERAS program of which 68 (87.2%) reported administering a preoperative drink. Of these, 98.5%, 80.9%, and 60.3% of hospitals administered a beverage to patients without diabetes, patients with diabetes not taking insulin, and patients with diabetes taking insulin, respectively. Surprisingly, one third of programs that administered a beverage to patients with diabetes used a simple carbohydrate drink. CONCLUSIONS: This survey finds a high use of CHO-containing beverages in colorectal ERAS programs. More than half of all programs administer a CHO-containing beverage to patients with diabetes, and surprisingly, there is significant use of simple carbohydrate beverages in patients with diabetes receiving insulin.

Retrospective Comparison of Intramuscular Admixtures of Ketamine and Dexmedetomidine Versus Ketamine and Midazolam for Preoperative Sedation.

Precooperative children and patients with intellectual disabilities often require intramuscular (IM) sedation prior to the induction of general anesthesia (GA). Ketamine is an effective preinduction sedative but can produce significant adverse side effects. Dexmedetomidine, a sedative with sympatholytic and analgesic properties, may provide advantages when used in combination with ketamine. This retrospective study evaluated the efficacy and safety of IM ketamine with dexmedetomidine for preoperative sedation. We conducted a chart review of all patients (n = 105) treated for dental rehabilitation who received either IM ketamine and dexmedetomidine (study group, n = 74) or IM ketamine and midazolam (control group, n = 31) prior to induction of GA. No significant difference (p = .14) was observed in the time interval from IM administration to operating room entry (median [interquartile range]) between the study and control groups (5 [4-8] vs 5 [2-7] minutes). Patients who received IM dexmedetomidine exhibited significantly lower mean arterial pressures throughout the induction (p = .004) and had lower heart rates (p = .01) throughout the intraoperative period compared with patients who did not receive dexmedetomidine. The combination of dexmedetomidine and ketamine may provide effective and safe IM sedation prior to the induction of GA.

Types of surgical patients enrolled in enhanced recovery after surgery (ERAS) programs in the USA.

BACKGROUND: Enhanced Recovery After Surgery (ERAS) programs have gained traction across US hospitals in the past two decades. Initially implemented for elective colorectal surgical procedures, ERAS has expanded to a variety of surgical service lines. There is little information regarding the extent to which various surgical service lines use ERAS. METHODS: A survey was performed to describe the prevalence of ERAS programs across surgical service lines in the USA. The survey had questions regarding the number of ERAS programs, operating rooms (ORs) and presence of anesthesia and/or surgery residency program at an institution. The survey was administered electronically to members of the American Society for Enhanced Recovery (ASER) and manually to participants at the 2018 Perioperative Quality and Enhanced Recovery Conference in San Francisco, CA. RESULTS: Responses were received from 88 unique institutions. The most commonly reported surgical service lines were colorectal (87%), gynecology (51%), orthopedic (49%), surgical oncology (39%), and urology (35%). A significant positive association was observed between the number of ORs and the number ERAS programs (Spearman's Rho 0.5, p<0.0001). Furthermore, institutions that reported an anesthesia and/or surgery residency program had more ERAS programs (mean 5.0 ± 3.2) compared to those that did not (mean 2.0 ± 2.0) (Wilcoxon rank sum p< 0.001). CONCLUSIONS: ERAS has expanded to a large extent outside of the colorectal surgery service line with increases notable in orthopedic surgery, obstetric/gynecology, surgical oncology, and urology procedures. Institutions with a higher number of ORs and the presence of an anesthesia and/or surgery residency program are associated with an increased number of ERAS programs.

Severe Acute Respiratory Syndrome Coronavirus 2 Convalescent Plasma Versus Standard Plasma in Coronavirus Disease 2019 Infected Hospitalized Patients in New York: A Double-Blind Randomized Trial.

OBJECTIVES: Four peer-reviewed publications have reported results from randomized controlled trials of convalescent plasma for coronavirus disease 2019 infection; none were conducted in the United States nor used standard plasma as a comparator. To determine if administration of convalescent plasma to patients with coronavirus disease 2019 increases antibodies to severe acute respiratory syndrome coronavirus 2 and improves outcome. DESIGN: Double-blind randomized controlled trial. SETTING: Hospital in New York. PATIENTS: Patients with polymerase chain reaction documented coronavirus disease 2019 infection. INTERVENTIONS: Patients were randomized (4:1) to receive 2 U of convalescent plasma versus standard plasma. Antibodies to severe acute respiratory syndrome coronavirus 2 were measured in plasma units and in trial recipients. MEASUREMENTS AND MAIN RESULTS: Enrollment was terminated after emergency use authorization was granted for convalescent plasma. Seventy-four patients were randomized. At baseline, mean (sd) Acute Physiology and Chronic Health Evaluation II score (23.4 [5.6] and 22.5 [6.6]), percent of patients intubated (19% and 20%), and median (interquartile range) days from symptom onset to randomization of 9 (6-18) and 9 (6-15), were similar in the convalescent plasma versus standard plasma arms, respectively. Convalescent plasma had high neutralizing activity (median [interquartile range] titer 1:526 [1:359-1:786]) and its administration increased antibodies to severe acute respiratory syndrome coronavirus 2 by 14.4%, whereas standard plasma administration led to an 8.6% decrease (p = 0.005). No difference was observed for ventilator-free days through 28 days (primary study endpoint): median (interquartile range) of 28 (2-28) versus 28 (0-28; p = 0.86) for the convalescent plasma and standard plasma groups, respectively. A greater than or equal to 2 point improvement in the World Health Organization scale was achieved by 20% of subjects in both arms (p = 0.99). All-cause mortality through 90 days was numerically lower in the convalescent plasma versus standard plasma groups (27% vs 33%; p = 0.63) but did not achieve statistical significance. A key prespecified subgroup analysis of time to death in patients who were intubated at baseline was statistically significant; however, sample size numbers were small. CONCLUSIONS: Administration of convalescent plasma to hospitalized patients with coronavirus disease 2019 infection increased antibodies to severe acute respiratory syndrome coronavirus disease 2 but was not associated with improved outcome.

Prevalence of IgM and IgG antibodies to SARS-CoV-2 in health care workers at a tertiary care New York hospital during the Spring COVID-19 surge.

BACKGROUND: Health care workers (HCW) such as anesthesiologists, surgeons, and intensivists face high rates of exposure to SARS-CoV-2 through direct contact with COVID-19 patients. While there are initial reports of the prevalence of COVID-19 antibodies among the general population, there are few reports comparing the seroprevalence of IgM/IgG COVID-19 antibodies in HCW of different exposure levels as well as different HCW professions. METHODS: A convenience sample of health care workers provided blood for COVID-19 antibody testing and a review of medical history and work exposure for correlative analyses. RESULTS: Overall, 474 HCW were enrolled in April 2020 including 102 front-line physicians (e.g., anesthesiologists, surgeons, intensivists, emergency medicine), 91 other physicians, 135 nurses, 134 other clinical staff, and 12 non-clinical HCW. The prevalence of IgM or IgG antibodies to SARS-CoV-2 was 16.9% (95% CI 13.6-20.6) (80/474). The proportion of positive antibodies in the PCR + group was significantly higher than health care workers without symptoms (84.6% [95% CI 54.6-98.1] vs. 12.3% [95% CI 8.5-17.2], p < 0.001). No significant differences in proportions of COVID-19 antibodies were observed among the different exposure groups (e.g., high vs minimal/no exposure) and among the different HCW professionals. CONCLUSIONS: Despite exposure to COVID-19 patients, the prevalence of antibodies in our HCW was similar to what has been reported for the general population of New York State (14%) and for another New York HCW cohort (13.7%). Health care workers with higher exposure rates were not more likely to have been infected with COVID-19. Therefore, these data suggest that infection of HCW may result from exposure in the community rather than at work. TRIAL REGISTRATION: This investigator-initiated study was observational; therefore, no registration was required. Not applicable.

Impact of serological and PCR testing requirements on the selection of COVID-19 convalescent plasma donors.

BACKGROUND: Convalescent plasma is undergoing randomized trials as a potential therapeutic option for COVID-19 infection. Little empirical evidence exists regarding the determination of donor eligibility and experiences with donor selection. STUDY DESIGN AND METHODS: This prospective study was conducted at a tertiary care hospital in New York to select plasma donors for a randomized, double-blind, controlled convalescent plasma trial. Clearance for donation required successful completion of an online questionnaire and an in-person screening visit, which included (a) completion of a Donor Health Questionnaire (DHQ), (b) Immunoglobulin G (IgG) antibody testing using an immunochromatographic anti- severe acute respiratory coronavirus 2 (SARS-CoV-2) test, (c) Polymerase chain reaction (PCR) testing if <28 days from symptom resolution, and (d) routine blood bank testing. RESULTS: After receiving 3093 online questionnaires, 521 individuals presented for in-person screening visits, with 40.1% (n = 209) fully qualifying. Subjects (n = 312) failed to progress due to the following reasons: disqualifying answer from DHQ (n = 30, 9.6%), insufficient antibodies (n = 198, 63.5%), persistent positive PCR tests (n = 14, 4.5%), and blood donation testing labs (n = 70, 22.4%). Importantly, 24.6% and 11.1% of potential donors who reported having PCR-diagnosed infection had low or undetectable SARS-CoV-2 antibody levels, respectively. Surprisingly, 62.9% (56/89) of subjects had positive PCR tests 14-27 days after symptom resolution, with 13 individuals continuing to be PCR positive after 27 days. CONCLUSION: It is feasible for a single site to fully qualify a large number of convalescent plasma donors in a short period of time. Among otherwise qualified convalescent plasma donors, we found high rates of low or undetectable antibody levels and many individuals with persistently positive PCR tests.