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).

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.

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.

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.

Randomized controlled trial of 7, 28, vs 42 day stored red blood cell transfusion on oxygen delivery (VO2 max) and exercise duration.

BACKGROUND: Few studies have rigorously assessed the impact of red blood cell (RBC) transfusion on oxygen delivery. Several large trials demonstrated no clinical outcome differences between transfusion of shorter-storage vs prolonged-storage RBCs. These trials did not directly assess functional measures of oxygen delivery. Therefore, it is not clear if 42-day stored RBCs deliver oxygen as effectively as 7-day stored RBCs. STUDY DESIGN AND METHODS: Leukocyte-reduced RBCs were collected by apheresis in AS-3. Thirty subjects were randomized (1:1:1) to receive 2 units of autologous RBCs at either 7, 28, or 42 days following donation. VO2 max testing, using a standardized protocol to exhaustion, was performed 2 days before (Monday) and 2 days after (Friday) the transfusion visit (Wednesday). The primary endpoint was the percent increase in VO2 max between Monday and Friday. The secondary endpoint was the percent change in duration of exercise for the same time points. RESULTS: Hemoglobin levels decreased by 2.8 ± 1.4 g/dL after donation and increased by 2.1 ± 0.6 g/dL after transfusion. This change in hemoglobin was associated with expected decreases (then increases after transfusion) in VO2 max and exercise duration. No differences were observed between 7-day and 42-day RBC transfusion for percent increase in median [IQR] VO2 max (10.5 [0.2-17.3] vs 10.9 [5.7-16.8], P = .41) or for percent increase in exercise duration (5.4 [4.1-6.9] vs 4.9 [2.0-7.2], P = .91), respectively. Results were similar for 28-day RBCs and were consistent across the ITT and per-protocol analysis populations. CONCLUSION: These data indicate that 42-day, 28-day, and 7-day RBCs have similar ability to deliver oxygen.

Neutralizing activity to SARS-CoV-2 of convalescent and control plasma used in a randomized controlled trial.

BACKGROUND: There are limited data on the neutralizing activity of convalescent plasma (CP) administered in randomized controlled trials (RCT) of COVID-19 infection. STUDY DESIGN AND METHODS: As part of an RCT, CP was collected per FDA guidelines from individuals recovered from COVID-19 infection. CP donors had to have ≥145 optical density (OD) units (ideal target ≥300) using a semiquantitative, immunochromatographic test for IgG antibody to the nucleocapsid protein (NP) of SARS-CoV-2 (typical range 0-500 OD units). A random subset of samples [14 control plasma, 12 CP "medium-anti-NP" (145-299 OD units), and 13 CP "high" anti-NP (≥300 OD units)] were tested for neutralizing antibodies using an established viral luciferase antibody inhibition assay to detect the infection of SARS-CoV-2 pseudovirus that encoded spike protein (SARS2-Strunc ) on a human immunodeficiency virus 1 vector (NL43dEnvNanoLuc), using ACE2-expressing 293 T cells. The titer needed to neutralize 50% of viral activity (NT50) was calculated. RESULTS: The uptake of SARS-CoV-2 pseudovirus by 293TACE2 cells was inhibited by pretreatment with CP compared to control CP (p < .001) with control plasma having a median (IQR) 50% neutralization titer (NT50) of 1:28 (1:16,1:36) compared to 1:334 (1:130,1:1295) and 1:324 (1:244,1:578), for medium anti-NP and high anti-NP CP units, respectively. The neutralizing activity of CP met minimum FDA criteria with neutralizing antibody titers >1:80 in 100% of randomly selected samples, using a conservative approach that excluded non-specific binding. DISCUSSION: Plasma from donors screened using an immunochromatographic test for IgG antibody to SARS-CoV-2 NP exhibited neutralizing activity meeting FDA's minimum standard in all randomly selected COVID-19 CP units.

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.

Comprehensive Quality Improvement Program for Intraoperative Transesophageal Echocardiography: Development, Implementation, and Initial Experience.

OBJECTIVE: To develop and implement a comprehensive transesophageal echocardiography (TEE) quality improvement (QI) program and assess for potential improvements in TEE performed by cardiac anesthesiologists. DESIGN: Prospective institutionally approved QI program. SETTING: Academic tertiary care center. PARTICIPANTS: The study comprised cardiac anesthesiologists. INTERVENTIONS: An instrument comprising 15 quality measures to assess TEE examinations pre- and post-cardiopulmonary bypass (CPB) was developed for the present study. TEE examinations before the introduction of the QI program were assessed retrospectively, and examinations performed after its introduction were reviewed prospectively over a 2-year period. MEASUREMENTS AND MAIN RESULTS: A total of 118 TEE studies were analyzed, 48 and 70 studies before and after introduction of the TEE QI program, respectively. Half of the studies were performed pre-CPB, and half of them were performed post-CPB. Multivariate linear mixed regression models were used to assess the effect of the QI program. Interrater variability was assessed among internal reviewers by means of the Shrout-Fleiss reliability intraclass correlation coefficient. Five quality measures demonstrated a significant improvement in studies after CPB after implementation, including 3 imaging criteria (left ventricle, tricuspid valve, and pulmonary artery) and 2 documentation criteria (completeness of demographic/clinical data and timely reporting of documentation). The inter-rater variability analysis yielded an average intraclass correlation coefficient of 0.90 before and 0.78 after the QI program initiation, consistent with excellent agreement among the 4 reviewers. CONCLUSIONS: The present study demonstrated the ability to create and implement a formal QI program for intraoperative TEE in an academic tertiary care cardiac surgical group. The initial data showed significant improvement in several quality measures related to TEE performance.

Validation of the translated Quality of Recovery-15 questionnaire in a French-speaking population.

BACKGROUND: Quality of recovery is an important component of perioperative health status. The 15-item Quality of Recovery (QoR-15) scale is a validated multidimensional questionnaire that measures postoperative quality of recovery. The aim of this study was to translate and assess the psychometric properties of a French version of the QoR-15 scale (QoR-15F) to measure postoperative recovery in French-speaking patients. METHODS: After translation into French of the original English version of the QoR-15 scale, psychometric validation of the QoR-15F scale to measure postoperative quality of recovery was performed. This psychometric validation included validity, reliability, responsiveness, and feasibility. The QoR-15F scale was administered before operation and on Postoperative day 1 in French-speaking patients. Patient-perceived global recovery assessment was measured at Postoperative day 1 using a VAS. RESULTS: We enrolled 150 patients, and 144 completed the study protocol. The completion rate of administered questionnaires was 100%. Pearson (r) correlation between postoperative QoR-15F and the global recovery assessment by the patient was 0.60 (P<0.0001). As expected, there was a significant negative correlation between QoR-15F score and duration of surgery (r=-0.29; P<0.01), duration of PACU stay (r=-0.21; P=0.01), and duration of hospital stay (r=-0.34; P<0.01). Cronbach's alpha was 0.81, split-half alpha was 0.83, and the global test-retest intra-class coefficient was 0.98 (0.95-0.99). CONCLUSIONS: The QoR-15F is a valid and reliable tool to measure postoperative quality of recovery in French-speaking patients. The psychometric properties to measure postoperative quality of recovery were similar to the seminal English version. CLINICAL TRIAL REGISTRATION: NCT03578068.

A randomized-controlled trial of sugammadex versus neostigmine: impact on early postoperative strength.

BACKGROUND: Residual neuromuscular blockade after surgery is associated with airway obstruction, hypoxia, and respiratory complications. Compared with neostigmine, sugammadex reverses neuromuscular blockade to a train-of-four ratio > 0.9 more rapidly. It is unknown, however, whether the superior reversal profile of sugammadex improves clinically relevant measures of strength in the early postoperative period. METHODS: Patients undergoing general, gynecological, or urologic surgery were randomized to receive either neostigmine (70 µg·kg-1, maximum 5 mg) or sugammadex (2 or 4 mg·kg-1) to reverse neuromuscular blockade. The primary outcome was the ability to breathe deeply measured by incentive spirometry at 30, 60, and 120 min after reversal. RESULTS: We randomized 62 patients to either a neostigmine (n = 31) or sugammadex (n = 31) group. The incentive spirometry volume recovery trajectory was not different between the two groups (P = 0.35). Median spirometry volumes at baseline, 30, 60, and 120 min postoperatively were 2650 vs 2500 mL, 1775 vs 1750 mL, 1375 vs 2000 mL, and 1800 vs 1950 mL for the sugammadex and neostigmine groups, respectively. Postoperative incentive spirometry decrease from baseline was not different between the two groups. Hand grip strength, the ability to sit unaided, train-of-four ratio on postanesthesia care unit (PACU) admission, time to extubation, time to PACU discharge readiness, and Quality of Recovery-15 scores were also not different between the groups. CONCLUSIONS: Measures of postoperative strength, such as incentive spirometry, hand group strength, and the ability to sit up in the early postoperative period were not different in patients who received neostigmine or sugammadex for the reversal of neuromuscular blockade. TRIAL REGISTRATION: www.clinicaltrials.gov (NCT02909439); registered: 21 September, 2016.

RéSUMé: CONTEXTE: Les blocs neuromusculaires résiduels après une chirurgie sont associés à l'obstruction des voies aériennes, à l'hypoxie et à des complications respiratoires. Par rapport à la néostigmine, le sugammadex neutralise le bloc neuromusculaire à un ratio de train-de-quatre (TOF) > 0,9 plus rapidement. Nous ne savons toutefois pas si le profil de neutralisation supérieur du sugammadex améliore les mesures pertinentes d'un point de vue clinique de la force en période postopératoire initiale. MéTHODE: Nous avons randomisé des patients subissant une chirurgie générale, gynécologique ou urologique à recevoir de la néostigmine (70 µg·kg-1, maximum 5 mg) ou du sugammadex (2 ou 4 mg·kg-1) pour neutraliser le bloc neuromusculaire. Le critère d'évaluation principal était la capacité des patients à respirer profondément telle que mesurée par spirométrie incitative à 30, 60 et 120 min après la neutralisation. RéSULTATS: Au total, 62 patients ont été randomisés dans les groupes néostigmine (n = 31) ou sugammadex (n = 31). Aucune différence dans la trajectoire de récupération de volume de spirométrie incitative n'a été observée entre les deux groupes (P = 0,35). Les volumes médians de spirométrie préopératoire et à 30, 60 et 120 min postopératoires étaient de 2650 vs 2500 mL, 1775 vs 1750 mL, 1375 vs 2000 mL, et 1800 vs 1950 mL pour les groupes sugammadex et néostigmine, respectivement. La diminution postopératoire de la spirométrie incitative par rapport aux valeurs de base était similaire dans les deux groupes. La force de préhension, la capacité à s'asseoir sans assistance, le ratio de train-de-quatre à l'admission à la salle de réveil, le délai jusqu'à l'extubation, le délai jusqu'à l'obtention des critères de congé de la salle de réveil et les scores de QoR-15 (mesurant la qualité de récupération) ne différaient pas non plus entre les groupes. CONCLUSION: Les mesures de la force postopératoire, telles que la spirométrie incitative, la force de préhension et la capacité de s'asseoir en période postopératoire initiale, ne différaient pas entre les patients ayant reçu de la néostigmine ou du sugammadex pour neutraliser le bloc neuromusculaire. ENREGISTREMENT DE L'éTUDE: www.clinicaltrials.gov (NCT02909439); enregistrée le 21 septembre 2016.

Anticoagulation Management and Heparin Resistance During Cardiopulmonary Bypass: A Survey of Society of Cardiovascular Anesthesiologists Members.

We surveyed Society of Cardiovascular Anesthesiologists members regarding anticoagulation practices for cardiopulmonary bypass and attitudes on heparin resistance. Of 550 respondents (18.5% response rate), 74.9% (95% CI, 71.3%-78.5%) used empiric weight-based dosing of heparin, and 70.7% (95% CI, 66.9%-74.5%) targeted an activated clotting time of either 400 or 480 seconds to initiate cardiopulmonary bypass. Of note, 17.1% (95% CI, 13.9%-20.2%) of respondents reported activated clotting time targets lower than those recommended by recent 2018 Society of Thoracic Surgeons/Society of Cardiovascular Anesthesiologists/American Society of Extracorporeal Technology guidelines or failed to monitor heparin effects at all. When heparin resistance was encountered, 54.2% of respondents (95% CI, 50.0%-58.4%) administered antithrombin concentrates as a first-line therapy.

Trainability of Cricoid Pressure Force Application: A Simulation-Based Study.

BACKGROUND: Aspiration of gastric contents is a leading cause of airway management-related mortality during anesthesia practice. Cricoid pressure (CP) is widely used during rapid sequence induction to prevent aspiration. National guidelines for CP suggest a target force of 10 N before and 30 N after loss of consciousness. However, few studies have rigorously assessed whether clinicians can be trained to consistently achieve these levels of force. We hypothesized that clinicians can be trained effectively to deliver 10-30 N during application of CP. METHODS: Clinicians (attending anesthesiologist, anesthesiology residents, certified registered nurse anesthetists, or operating room nurses) applied CP on a Vernier force plate simulator with measurements taken at 4 time points over 60 seconds, 2 measurements before and 2 measurements after loss of consciousness. A successful cycle required all 4 time points to be within the target range (10 ± 5 and 30 ± 5 N, respectively). After baseline assessment (n = 100 clinicians), a subset of 40 participants volunteered for education on recommended force targets, underwent self-regulated practice, and then performed 30 1-minute cycles of high-frequency simulation analyzed by cumulative sum analysis to assess their change in performance. RESULTS: At baseline, 5 cycles (1.3% [confidence interval {CI}, 0.3%-2.50%]) out of 400 were successful. Performance improved after education and self-regulated practice (16% successful cycles [CI, 7.8%-25%]), and performance during the last 4 of 30 cycles was 45% (CI, 33%-58%). The odds of success increased over time (odds ratio, 1.1; P < .001). By cumulative sum analysis, however, no subject crossed the h0 line, indicating that no one achieved proficiency of the predefined target forces. CONCLUSIONS: At baseline, performance was poor at achieving target forces specified by national guidelines. Simulation-based training improved the success rate, but no participant achieved the predefined threshold for proficiency.

A ten-year retrospective study of post-dural puncture headache in 32,655 obstetric patients.

PURPOSE: Accidental dural puncture and post-dural puncture headache are well-known complications of neuraxial anesthesia in parturients. The primary goal of this study was to identify the rate of post-dural puncture headache and epidural blood patch in all parturients who received a neuraxial anesthetic during a ten-year period at an academic tertiary-care medical centre. A secondary goal was to identify any delay in hospital discharge due to a post-dural puncture headache. METHODS: We conducted a retrospective analysis of all patients who received a neuraxial anesthetic on the labour and delivery unit at Stony Brook Medical Center from 1 January, 2006 to 31 December, 2015. Standardized neuraxial anesthesia equipment was used throughout this period. Chart reviews were conducted on all patients who received a neuraxial anesthetic and had an accidental dural puncture and/or developed a post-dural puncture headache. RESULTS: Of the 32,655 neuraxial anesthetics performed, 298 (0.9%) patients experienced a post- dural puncture headache. Analysis of all patients who developed a post-dural puncture headache showed that 150 (50.3%) patients received one or more epidural blood patches. Overall, 19 (0.06%) patients had a delay in hospital discharge due to a post-dural puncture headache. CONCLUSIONS: We showed a relatively low incidence (< 1%) of post-dural puncture headache following neuraxial anesthesia in parturients at an academic tertiary-care medical centre. Patients that rated their post-dural puncture headache as very severe were more likely to undergo at least one epidural blood patch procedure. Post-dural puncture headache is a well-known complication of neuraxial anesthesia, and may lead to a delay in hospital discharge.

Efficacy of acupressure on quality of recovery after surgery: Randomised controlled trial.

BACKGROUND: Acupressure therapy is associated with favourable efficacies on postoperative nausea, pain and sleep disturbance, although the quality of the evidence is generally low. No randomised clinical trial has yet assessed the effect of acupressure on postoperative quality of recovery (QoR). OBJECTIVE: The objective was to study acupressure efficacy on patient-reported postoperative recovery. DESIGN: We conducted a single centre, three-group, blind, randomised controlled, pragmatic trial assessing acupressure therapy on the PC6, LI4 and HT7 acupoints. PATIENTS: Postoperative patients expected to stay in hospital at least 2 days after surgery. INTERVENTIONS: In the acupressure group, pressure was applied for 6 min (2 min per acupoint), three times a day after surgery for a maximum of 2 postoperative days during the hospital stay. In the sham group, extremely light touch was applied to the acupoints. The third group did not receive any touch. MAIN OUTCOME MEASURES: The primary outcome was the change in the QoR, using the QoR-15 questionnaire, between postoperative days 1 and 3. Key secondary outcomes included patients' satisfaction, postoperative nausea and vomiting, pain score and opioid (morphine equivalent) consumption. Assessors for the primary and secondary endpoints were blind to the group allocation. RESULTS: Overall, 163 patients were randomised (acupressure n=55, sham n=53, no intervention n=55). The mean (SD) postoperative change in QoR-15 did not differ statistically (P = 0.27) between the acupressure, sham and no intervention groups: 15.2 (17.8), 14.2 (21.9), 9.2 (21.7), respectively. Patient satisfaction (on a 0 to 10 scale) was statistically different (P = 0.01) among these three groups: 9.1 (1.5), 8.4 (1.6) and 8.2 (2.2), respectively. Changes in pain score and morphine equivalent consumption were not significantly different between the groups. CONCLUSION: Two days of postoperative acupressure therapy (up to six treatments) did not significantly improve patient QoR, postoperative nausea and vomiting, pain score or opioid consumption. Acupressure, however, was associated with improved patient satisfaction. TRIAL REGISTRATION: ClinicalTrials.gov, identifier: NCT02762435.

Effects of red-cell storage duration on patients undergoing cardiac surgery.

BACKGROUND: Some observational studies have reported that transfusion of red-cell units that have been stored for more than 2 to 3 weeks is associated with serious, even fatal, adverse events. Patients undergoing cardiac surgery may be especially vulnerable to the adverse effects of transfusion. METHODS: We conducted a randomized trial at multiple sites from 2010 to 2014. Participants 12 years of age or older who were undergoing complex cardiac surgery and were likely to undergo transfusion of red cells were randomly assigned to receive leukocyte-reduced red cells stored for 10 days or less (shorter-term storage group) or for 21 days or more (longer-term storage group) for all intraoperative and postoperative transfusions. The primary outcome was the change in Multiple Organ Dysfunction Score (MODS; range, 0 to 24, with higher scores indicating more severe organ dysfunction) from the preoperative score to the highest composite score through day 7 or the time of death or discharge. RESULTS: The median storage time of red-cell units provided to the 1098 participants who received red-cell transfusion was 7 days in the shorter-term storage group and 28 days in the longer-term storage group. The mean change in MODS was an increase of 8.5 and 8.7 points, respectively (95% confidence interval for the difference, -0.6 to 0.3; P=0.44). The 7-day mortality was 2.8% in the shorter-term storage group and 2.0% in the longer-term storage group (P=0.43); 28-day mortality was 4.4% and 5.3%, respectively (P=0.57). Adverse events did not differ significantly between groups except that hyperbilirubinemia was more common in the longer-term storage group. CONCLUSIONS: The duration of red-cell storage was not associated with significant differences in the change in MODS. We did not find that the transfusion of red cells stored for 10 days or less was superior to the transfusion of red cells stored for 21 days or more among patients 12 years of age or older who were undergoing complex cardiac surgery. (Funded by the National Heart, Lung, and Blood Institute; RECESS ClinicalTrials.gov number, NCT00991341.).

American Society for Enhanced Recovery and Perioperative Quality Initiative Joint Consensus Statement on Nutrition Screening and Therapy Within a Surgical Enhanced Recovery Pathway.

Perioperative malnutrition has proven to be challenging to define, diagnose, and treat. Despite these challenges, it is well known that suboptimal nutritional status is a strong independent predictor of poor postoperative outcomes. Although perioperative caregivers consistently express recognition of the importance of nutrition screening and optimization in the perioperative period, implementation of evidence-based perioperative nutrition guidelines and pathways in the United States has been quite limited and needs to be addressed in surgery-focused recommendations. The second Perioperative Quality Initiative brought together a group of international experts with the objective of providing consensus recommendations on this important topic with the goal of (1) developing guidelines for screening of nutritional status to identify patients at risk for adverse outcomes due to malnutrition; (2) address optimal methods of providing nutritional support and optimizing nutrition status preoperatively; and (3) identifying when and how to optimize nutrition delivery in the postoperative period. Discussion led to strong recommendations for implementation of routine preoperative nutrition screening to identify patients in need of preoperative nutrition optimization. Postoperatively, nutrition delivery should be restarted immediately after surgery. The key role of oral nutrition supplements, enteral nutrition, and parenteral nutrition (implemented in that order) in most perioperative patients was advocated for with protein delivery being more important than total calorie delivery. Finally, the role of often-inadequate nutrition intake in the posthospital setting was discussed, and the role of postdischarge oral nutrition supplements was emphasized.

American Society for Enhanced Recovery and Perioperative Quality Initiative Joint Consensus Statement on Patient-Reported Outcomes in an Enhanced Recovery Pathway.

Patient-reported outcomes (PROs) are measures of health status that come directly from the patient. PROs are an underutilized tool in the perioperative setting. Enhanced recovery pathways (ERPs) have primarily focused on traditional measures of health care quality such as complications and hospital length of stay. These measures do not capture postdischarge outcomes that are meaningful to patients such as function or freedom from disability. PROs can be used to facilitate shared decisions between patients and providers before surgery and establish benchmark recovery goals after surgery. PROs can also be utilized in quality improvement initiatives and clinical research studies. An expert panel, the Perioperative Quality Initiative (POQI) workgroup, conducted an extensive literature review to determine best practices for the incorporation of PROs in an ERP. This international group of experienced clinicians from North America and Europe met at Stony Brook, NY, on December 2-3, 2016, to review the evidence supporting the use of PROs in the context of surgical recovery. A modified Delphi method was used to capture the collective expertise of a diverse group to answer clinical questions. During 3 plenary sessions, the POQI PRO subgroup presented clinical questions based on a literature review, presented evidenced-based answers to those questions, and developed recommendations which represented a consensus opinion regarding the use of PROs in the context of an ERP. The POQI workgroup identified key criteria to evaluate patient-reported outcome measures (PROMs) for their incorporation in an ERP. The POQI workgroup agreed on the following recommendations: (1) PROMs in the perioperative setting should be collected in the framework of physical, mental, and social domains. (2) These data should be collected preoperatively at baseline, during the immediate postoperative time period, and after hospital discharge. (3) In the immediate postoperative setting, we recommend using the Quality of Recovery-15 score. After discharge at 30 and 90 days, we recommend the use of the World Health Organization Disability Assessment Scale 2.0, or a tailored use of the Patient-Reported Outcomes Measurement Information System. (4) Future study that consistently applies PROMs in an ERP will define the role these measures will have evaluating quality and guiding clinical care. Consensus guidelines regarding the incorporation of PRO measures in an ERP were created by the POQI workgroup. The inclusion of PROMs with traditional measures of health care quality after surgery provides an opportunity to improve clinical care.

American Society for Enhanced Recovery and Perioperative Quality Initiative Joint Consensus Statement on Postoperative Gastrointestinal Dysfunction Within an Enhanced Recovery Pathway for Elective Colorectal Surgery.

The primary driver of length of stay after bowel surgery, particularly colorectal surgery, is the time to return of gastrointestinal (GI) function. Traditionally, delayed GI recovery was thought to be a routine and unavoidable consequence of surgery, but this has been shown to be false in the modern era owing to the proliferation of enhanced recovery protocols. However, impaired GI function is still common after colorectal surgery, and the current literature is ambiguous with regard to the definition of postoperative GI dysfunction (POGD), or what is typically referred to as ileus. This persistent ambiguity has impeded the ability to ascertain the true incidence of the condition and study it properly within a research setting. Furthermore, a rational and standardized approach to prevention and treatment of POGD is needed. The second Perioperative Quality Initiative brought together a group of international experts to review the published literature and provide consensus recommendations on this important topic with the goal to (1) develop a rational definition for POGD that can serve as a framework for clinical and research efforts; (2) critically review the evidence behind current prevention strategies and provide consensus recommendations; and (3) develop rational treatment strategies that take into account the wide spectrum of impaired GI function in the postoperative period.

A randomized controlled pilot study of VO2 max testing: a potential model for measuring relative in vivo efficacy of different red blood cell products.

BACKGROUND: Randomized trials, for example, RECESS, comparing "young" (median, 7-day) versus "middle-aged" (median, 28-day) red blood cells (RBCs), showed no difference in outcome. These data are important; however, they do not inform us about the safety and effectiveness of the oldest RBCs, which some patients receive. It may not be feasible to conduct a clinical trial randomizing patients to receive the oldest blood. Therefore, we propose strenuous exercise (VO2 max testing) as a model to study the relative efficacy to increase oxygen delivery to tissue of different RBC products, for example, extremes of storage duration. STUDY DESIGN AND METHODS: In this pilot study, eight healthy subjects had 2 units of leukoreduced RBCs collected by apheresis in AS-3 using standard methods. Subjects were randomized to receive both (2) units of their autologous RBCs at either 7 or 42 days after blood collection. VO2 max testing on a cycle ergometer was performed 2 days before (Monday) and 2 days after (Friday) the transfusion visit (Wednesday). This design avoids confounding effects on intravascular volume from the 2-unit blood transfusion. The primary outcome was the difference in VO2 max between Friday and Monday (delta VO2 max). RESULTS: VO2 max increased more in the 7-day RBC arm (8.7 ± 6.9% vs. 1.9 ± 6.5%, p = 0.202 for comparison between arms). Exercise duration (seconds) increased in the 7-day RBC arm (8.4 ± 1.7%) but actually decreased in the 42-day arm (-2.6 ± 3.6%, p = 0.002). CONCLUSIONS: This pilot study suggests that VO2 max testing has potential as a rigorous and quantitative in vivo functional assay of RBC function. Our preliminary results suggest that 42-day RBCs are inferior to 7-day RBCs at delivering oxygen to tissues.

Marriage and mortality after noncardiac surgery.

BACKGROUND: Marriage is linked to substantial societal and economic benefits, and it has been associated with improved outcomes following acute illness. However, it is not known if being married confers benefit to patients undergoing noncardiac surgical procedures. MATERIALS AND METHODS: Patients undergoing any noncardiac surgical procedure were included over a period of 19 months. All-cause mortality at 2 years was determined by linking patient records to the National Death Index. Risk adjustment was performed using Cox modeling and the Cleveland Clinic risk stratification index. RESULTS: Of the 11,588 patients included, 7830 (68.0%) were married at the time of surgery. There was a significant interaction between sex and marital status (P = 0.03), so the remainder of the analysis was performed separately by sex. Among men, not being married was associated with significantly worse survival (hazard ratio [HR]: 1.31, 95% confidence interval [CI]: 1.06, 1.63), whereas among women, there was no significant association between marital status and survival (HR: 0.94, 95% CI: 0.77, 1.15). Furthermore, divorced men (HR: 1.76, 95% CI: 1.25, 2.51) and never married men (HR: 1.53, 95% CI: 1.14, 2.05) had significantly worse survival than married men, whereas there was no significant difference between widowed men and married men, nor when comparing widowed, divorced, or never married women to married women. CONCLUSIONS: Among a diverse group of surgical patients, being married at the time of surgery is associated with significantly improved survival only among men. Focused efforts to improve social support for unmarried male patients may improve outcomes.