Tranexamic Acid in Patients Undergoing Noncardiac Surgery.

BACKGROUND: Perioperative bleeding is common in patients undergoing noncardiac surgery. Tranexamic acid is an antifibrinolytic drug that may safely decrease such bleeding. METHODS: We conducted a trial involving patients undergoing noncardiac surgery. Patients were randomly assigned to receive tranexamic acid (1-g intravenous bolus) or placebo at the start and end of surgery (reported here) and, with the use of a partial factorial design, a hypotension-avoidance or hypertension-avoidance strategy (not reported here). The primary efficacy outcome was life-threatening bleeding, major bleeding, or bleeding into a critical organ (composite bleeding outcome) at 30 days. The primary safety outcome was myocardial injury after noncardiac surgery, nonhemorrhagic stroke, peripheral arterial thrombosis, or symptomatic proximal venous thromboembolism (composite cardiovascular outcome) at 30 days. To establish the noninferiority of tranexamic acid to placebo for the composite cardiovascular outcome, the upper boundary of the one-sided 97.5% confidence interval for the hazard ratio had to be below 1.125, and the one-sided P value had to be less than 0.025. RESULTS: A total of 9535 patients underwent randomization. A composite bleeding outcome event occurred in 433 of 4757 patients (9.1%) in the tranexamic acid group and in 561 of 4778 patients (11.7%) in the placebo group (hazard ratio, 0.76; 95% confidence interval [CI], 0.67 to 0.87; absolute difference, -2.6 percentage points; 95% CI, -3.8 to -1.4; two-sided P<0.001 for superiority). A composite cardiovascular outcome event occurred in 649 of 4581 patients (14.2%) in the tranexamic acid group and in 639 of 4601 patients (13.9%) in the placebo group (hazard ratio, 1.02; 95% CI, 0.92 to 1.14; upper boundary of the one-sided 97.5% CI, 1.14; absolute difference, 0.3 percentage points; 95% CI, -1.1 to 1.7; one-sided P = 0.04 for noninferiority). CONCLUSIONS: Among patients undergoing noncardiac surgery, the incidence of the composite bleeding outcome was significantly lower with tranexamic acid than with placebo. Although the between-group difference in the composite cardiovascular outcome was small, the noninferiority of tranexamic acid was not established. (Funded by the Canadian Institutes of Health Research and others; POISE-3 ClinicalTrials.gov number, NCT03505723.).

Ultrasound-Guided Suprazygomatic Maxillary Nerve Block Is Effective in Reducing Postoperative Opioid Use Following Bimaxillary Osteotomy.

BACKGROUND: Ultrasound-guided maxillary nerve block has recently been described, though its impact upon bimaxillary osteotomy has not been formally investigated. PURPOSE: The present study was carried out to determine whether the addition of ultrasound-guided maxillary nerve block in subjects undergoing bimaxillary osteotomy reduces opioid use. STUDY DESIGN, SETTING, SAMPLE: A randomized clinical trial was carried out in adults undergoing bimaxillary osteotomy between April 2019 and January 2020 at Teknon Medical Center (Barcelona, Spain). PREDICTOR VARIABLE: The predictor variable was the treatment technique used (maxillary nerve block or no block). The subjects were randomized to either receive (test group) or not receive (control group) bilateral ultrasound-guided suprazygomatic maxillary nerve block (5 ml of 0.37% ropivacaine) before surgery. MAIN OUTCOME VARIABLE(S): The primary outcome variable was the intravenous methadone requirements in the first two postoperative hours. The secondary outcome variables were postoperative pain, rescue subcutaneous methadone, intravenous remifentanil used intraoperatively, the incidence of postoperative nausea-vomiting, and complications derived from maxillary nerve block. COVARIATES: Subject age, sex, weight, height, and anesthetic risk, and the duration of surgery were recorded. ANALYSES: Descriptive and inferential analyses were performed using the χ2 test and Mann-Whitney U test. Statistical significance was considered for P < .05. RESULTS: The baseline sample consisted of 68 subjects scheduled for bimaxillary osteotomy. The follow-up sample comprised 60 subjects: 30 in the control group (10 females and 20 males, aged 34.0 ± 10.2 years) and 30 in the test group (13 females and 17 males, aged 29.8 ± 10.8 years). The subjects who received maxillary nerve block showed less intravenous methadone use in the first 2 hours postsurgery (median 2.0 mg control group vs 0 mg test group; P < .001), lower pain levels at any time during the first 18 hours postsurgery (median visual analog score 4 control group vs 2 test group; P < .001), and a lesser percentage required methadone (33.3% control group vs 0% test group; P < .01) at 4-18 hours postsurgery. CONCLUSION AND RELEVANCE: The results obtained suggest that ultrasound-guided maxillary nerve block is a promising anesthetic technique capable of reducing intraoperative and postoperative opioid use, with greater patient comfort in bimaxillary osteotomy.

Hypotension-Avoidance Versus Hypertension-Avoidance Strategies in Noncardiac Surgery : An International Randomized Controlled Trial.

BACKGROUND: Among patients having noncardiac surgery, perioperative hemodynamic abnormalities are associated with vascular complications. Uncertainty remains about what intraoperative blood pressure to target and how to manage long-term antihypertensive medications perioperatively. OBJECTIVE: To compare the effects of a hypotension-avoidance and a hypertension-avoidance strategy on major vascular complications after noncardiac surgery. DESIGN: Partial factorial randomized trial of 2 perioperative blood pressure management strategies (reported here) and tranexamic acid versus placebo. (ClinicalTrials.gov: NCT03505723). SETTING: 110 hospitals in 22 countries. PATIENTS: 7490 patients having noncardiac surgery who were at risk for vascular complications and were receiving 1 or more long-term antihypertensive medications. INTERVENTION: In the hypotension-avoidance strategy group, the intraoperative mean arterial pressure target was 80 mm Hg or greater; before and for 2 days after surgery, renin-angiotensin-aldosterone system inhibitors were withheld and the other long-term antihypertensive medications were administered only for systolic blood pressures 130 mm Hg or greater, following an algorithm. In the hypertension-avoidance strategy group, the intraoperative mean arterial pressure target was 60 mm Hg or greater; all antihypertensive medications were continued before and after surgery. MEASUREMENTS: The primary outcome was a composite of vascular death and nonfatal myocardial injury after noncardiac surgery, stroke, and cardiac arrest at 30 days. Outcome adjudicators were masked to treatment assignment. RESULTS: The primary outcome occurred in 520 of 3742 patients (13.9%) in the hypotension-avoidance group and in 524 of 3748 patients (14.0%) in the hypertension-avoidance group (hazard ratio, 0.99 [95% CI, 0.88 to 1.12]; P = 0.92). Results were consistent for patients who used 1 or more than 1 antihypertensive medication in the long term. LIMITATION: Adherence to the assigned strategies was suboptimal; however, results were consistent across different adherence levels. CONCLUSION: In patients having noncardiac surgery, our hypotension-avoidance and hypertension-avoidance strategies resulted in a similar incidence of major vascular complications. PRIMARY FUNDING SOURCE: Canadian Institutes of Health Research, National Health and Medical Research Council (Australia), and Research Grant Council of Hong Kong.

Myocardial injury after major non-cardiac surgery evaluated with advanced cardiac imaging: a pilot study.

BACKGROUND: Myocardial injury after non-cardiac surgery (MINS) is a frequent complication caused by cardiac and non-cardiac pathophysiological mechanisms, but often it is subclinical. MINS is associated with increased morbidity and mortality, justifying the need to its diagnose and the investigation of their causes for its potential prevention. METHODS: Prospective, observational, pilot study, aiming to detect MINS, its relationship with silent coronary artery disease and its effect on future adverse outcomes in patients undergoing major non-cardiac surgery and without postoperative signs or symptoms of myocardial ischemia. MINS was defined by a high-sensitive cardiac troponin T (hs-cTnT) concentration > 14 ng/L at 48-72 h after surgery and exceeding by 50% the preoperative value; controls were the operated patients without MINS. Within 1-month after discharge, cardiac computed tomography angiography (CCTA) and magnetic resonance imaging (MRI) studies were performed in MINS and control subjects. Significant coronary artery disease (CAD) was defined by a CAD-RADS category ≥ 3. The primary outcomes were prevalence of CAD among MINS and controls and incidence of major cardiovascular events (MACE) at 1-year after surgery. Secondary outcomes were the incidence of individual MACE components and mortality. RESULTS: We included 52 MINS and 12 controls. The small number of included patients could be attributed to the study design complexity and the dates of later follow-ups (amid COVID-19 waves). Significant CAD by CCTA was equally found in 20 MINS and controls (30% vs 33%, respectively). Ischemic patterns (n = 5) and ischemic segments (n = 2) depicted by cardiac MRI were only observed in patients with MINS. One-year MACE were also only observed in MINS patients (15.4%). CONCLUSION: This study with advanced imaging methods found a similar CAD frequency in MINS and control patients, but that cardiac ischemic findings by MRI and worse prognosis were only observed in MINS patients. Our results, obtained in a pilot study, suggest the need of further, extended studies that screened systematically MINS and evaluated its relationship with cardiac ischemia and poor outcomes. Trial registration Clinicaltrials.gov identifier: NCT03438448 (19/02/2018).

COVID-19 Infection in Critically Ill Patients Carries a High Risk of Venous Thrombo-embolism.

OBJECTIVE: The coronavirus disease of 2019 (COVID-19) due to SARS-CoV-2 infection has been found to cause an increased risk of venous thrombo-embolism (VTE). The aims of the study were to determine the frequency of VTE in critically ill patients with COVID-19 and its correlation with D dimer levels and pharmacological prophylaxis. METHODS: This was a cohort study of critically ill patients due to COVID-19. All patients admitted to the intensive care unit on the same day of April 2020 were selected, regardless of length of stay, and a single bilateral venous duplex ultrasound in the lower extremities was performed up to 72 hours later. Pulmonary embolism (PE) was diagnosed by computed tomography angiography. Asymptomatic and symptomatic VTE were registered, including pre-screening in hospital VTE. Characteristics of patients, blood test results, doses of thromboprophylaxis received, VTE events, and mortality after seven day follow up were recorded. RESULTS: A total of 230 critically ill patients were studied. The median intensive care unit stay of these patients was 12 days (interquartile range [IQR] 5 - 19 days). After seven days follow up, the frequency of patients with VTE, both symptomatic and asymptomatic, was 26.5% (95% confidence interval [CI] 21% - 32%) (69 events in 61 patients): 45 with DVT and 16 with PE (eight of them with concomitant DVT). The cumulative frequency of symptomatic VTE was 8.3% (95% CI 4.7% - 11.8%). D dimer values ≥ 1 500 ng/mL were diagnostic of VTE, with a sensitivity of 80% and a specificity of 42%. During follow up after screening, six patients developed new VTE. Three of them developed a recurrence after a DVT diagnosed at screening, despite receiving therapeutic doses of heparin. Mortality rates at seven day follow up were the same for those with (6.6%) and without (5.3%) VTE. CONCLUSION: Patients with severe COVID-19 infection are at high risk of VTE, and further new symptomatic VTE events and recurrence can occur despite anticoagulation. The prophylactic anticoagulant dose may need to be increased in patients with a low risk of bleeding.

Clonidine as an Adjuvant to Bupivacaine for Suprazygomatic Maxillary Nerve Blocks in Cleft lip and Palate Repair: A Randomized, Prospective, Double-Blind Study.

OBJECTIVES: Does clonidine, as adjuvant to bupivacaine for suprazygomatic maxillary nerve blocks, reduce emergence agitation in patients undergoing cleft lip and cleft palate surgery? DESIGN: Randomized, controlled, and double-blind study. SETTING: Guwahati Comprehensive Cleft Care Center, Guwahati (Assam, India). PARTICIPANTS: A total of 124 patients; with a median age of 5 years in the clonidine group (CLG) and 7 years in the control group (CG), who underwent cleft lip or cleft palate surgery were included. Exclusion criteria included lack of consent from patients or their guardians, allergy to local anesthetics, coagulation disorders, local infection at the puncture site before performing the block, and language difficulties or cognitive disorders. INTERVENTIONS: Patients were randomized into 2 groups to receive bilateral suprazygomatic maxillary nerve blocks with either a bupivacaine/clonidine mixture for the CLG or bupivacaine alone in the CG. MAIN OUTCOME MEASURE: The primary end point was the incidence of emergence agitation. RESULTS: There was a statistically significant difference in the incidence of emergence agitation (30.2% in the CG compared to 15.2% in the CLG; difference of incidences: 15%, 95% CI: 0.1-30.1). The percentage of patients requiring intraoperative Fentanyl was lower in the CLG (10.6% compared to 26.4%; difference of incidences: 15.8%, 95% CI: 1.8-29). No other differences were observed. Further research in a more typically aged children population undergoing cleft surgery is needed. CONCLUSIONS: The use of clonidine as an adjuvant to bupivacaine in maxillary nerve block reduces the incidence of emergence agitation and intraoperative opioid consumption without hemodynamic or sedative side effects in patients undergoing cleft lip and palate surgery.

Myocardial Injury After Noncardiac Surgery: Incidence, Predictive Factors, and Outcome in High-Risk Patients Undergoing Thoracic Surgery: An Observational Study.

OBJECTIVE: The authors aimed to evaluate the incidence of myocardial injury after noncardiac surgery (MINS), its relationship with perioperative variables, and its prognostic implications for 30-day mortality in high-risk thoracic surgery patients. DESIGN: Observational study including cardiovascular high-risk patients undergoing routine postoperative troponin monitoring during the first 2 postoperative days. MINS was diagnosed based on at least 1 troponin I determination ≥0.04 ng/mL with no evidence of a nonischemic etiology. SETTING: Tertiary university hospital. PARTICIPANTS: Adult patients with cardiac risk factors, defined as patients ≥65 years old or patients <65 years old with known cardiovascular pathology (history of cardiac, cerebral, or peripheral vascular pathology) who underwent elective thoracic surgery. MEASUREMENT AND MAIN RESULTS: Forty-eight patients (27.3%) (95% confidence interval [CI] 20.8%-34.5%) of 177 had diagnostic criteria for MINS. On univariate analysis, an association was found between MINS and smoking (odds ratio [OR] 2.17, 95% CI 1.26-3.76), lobectomy (OR 1.30, 95% CI 1.03-1.66), pneumonectomy (OR 6.72, 95% CI 1.35-33.9), use of vasoactive drugs (OR 1.94, 95% CI 1.03-3.65), and pericardial incision (OR 6.72, 95% CI 1.35-33.9). On multivariate logistic regression analysis, only smoker status and type of surgery were independent risk factors for MINS. No association was found between MINS and 30-day mortality. CONCLUSIONS: Based on the findings, the elevated incidence of MINS after thoracic surgery, the independent relationship with the extent of lung resection, and the fact that MINS was not associated with greater mortality suggest that nonischemic causes may contribute to troponin elevation after thoracic surgeries.

Dabigatran in patients with myocardial injury after non-cardiac surgery (MANAGE): an international, randomised, placebo-controlled trial.

BACKGROUND: Myocardial injury after non-cardiac surgery (MINS) increases the risk of cardiovascular events and deaths, which anticoagulation therapy could prevent. Dabigatran prevents perioperative venous thromboembolism, but whether this drug can prevent a broader range of vascular complications in patients with MINS is unknown. The MANAGE trial assessed the potential of dabigatran to prevent major vascular complications among such patients. METHODS: In this international, randomised, placebo-controlled trial, we recruited patients from 84 hospitals in 19 countries. Eligible patients were aged at least 45 years, had undergone non-cardiac surgery, and were within 35 days of MINS. Patients were randomly assigned (1:1) to receive dabigatran 110 mg orally twice daily or matched placebo for a maximum of 2 years or until termination of the trial and, using a partial 2-by-2 factorial design, patients not taking a proton-pump inhibitor were also randomly assigned (1:1) to omeprazole 20 mg once daily, for which results will be reported elsewhere, or matched placebo to measure its effect on major upper gastrointestinal complications. Research personnel randomised patients through a central 24 h computerised randomisation system using block randomisation, stratified by centre. Patients, health-care providers, data collectors, and outcome adjudicators were masked to treatment allocation. The primary efficacy outcome was the occurrence of a major vascular complication, a composite of vascular mortality and non-fatal myocardial infarction, non-haemorrhagic stroke, peripheral arterial thrombosis, amputation, and symptomatic venous thromboembolism. The primary safety outcome was a composite of life-threatening, major, and critical organ bleeding. Analyses were done according to the intention-to-treat principle. This trial is registered with ClinicalTrials.gov, number NCT01661101. FINDINGS: Between Jan 10, 2013, and July 17, 2017, we randomly assigned 1754 patients to receive dabigatran (n=877) or placebo (n=877); 556 patients were also randomised in the omeprazole partial factorial component. Study drug was permanently discontinued in 401 (46%) of 877 patients allocated to dabigatran and 380 (43%) of 877 patients allocated to placebo. The composite primary efficacy outcome occurred in fewer patients randomised to dabigatran than placebo (97 [11%] of 877 patients assigned to dabigatran vs 133 [15%] of 877 patients assigned to placebo; hazard ratio [HR] 0·72, 95% CI 0·55-0·93; p=0·0115). The primary safety composite outcome occurred in 29 patients (3%) randomised to dabigatran and 31 patients (4%) randomised to placebo (HR 0·92, 95% CI 0·55-1·53; p=0·76). INTERPRETATION: Among patients who had MINS, dabigatran 110 mg twice daily lowered the risk of major vascular complications, with no significant increase in major bleeding. Patients with MINS have a poor prognosis; dabigatran 110 mg twice daily has the potential to help many of the 8 million adults globally who have MINS to reduce their risk of a major vascular complication [corrected]. FUNDING: Boehringer Ingelheim and Canadian Institutes of Health Research.

Effectiveness of a visual noise warning system on noise levels in a surgical ICU: A quality improvement programme.

BACKGROUND: The effects of noise are harmful to patients in the ICU environment, and the latter are particularly noisy places. High noise levels seem to be a factor in sleep disturbance, which can, in turn, result in increased morbidity. LOCAL PROBLEM: High noise levels are a recognised problem in ICUs worldwide. OBJECTIVE(S): The goal was to estimate the effect of a visual noise-warning system on noise levels in a surgical ICU before and after its implementation. DESIGN: A quality improvement initiative. SETTING: A 12-bedded surgical ICU in a tertiary care university hospital. PATIENTS: A total of 148 adult nonintubated and nonsedated patients completed the study, during a 6-week period. INTERVENTION: Noise levels were continuously recorded using a Type II sound level meter for 6 weeks. The study was divided into three phases. The first 2 weeks, baseline noise levels were measured (phase I). In week 3 of the study, a visual noise warning system (SoundEar II) that changed colour depending on noise levels within the ICU was installed and implemented (phase II). The alarm system was set to light up green at levels below 55 dBA, orange at levels between 55 and 60 dBA and red at levels above 60 dBA. The device was switched off at the beginning of week 5 and the sound level meter continued recording noise levels for another 2 weeks (phase III). RESULTS: Mean night-time noise level was 55.98 dBA in the preintervention phase, 54.14 dB during the intervention, and 54.98 dBA in the postintervention phase. Mean noise level was reduced statistically significantly by 1.35 dBA, and there was a sustained reduction of 0.86 dBA from the baseline noise level 2 weeks after SoundEar II was switched off. CONCLUSION: Visual noise warning systems can be effective in achieving a reduction in noise levels in critical care units.

Bilateral suprazygomatic maxillary nerve blocks vs. infraorbital and palatine nerve blocks in cleft lip and palate repair: A double-blind, randomised study.

BACKGROUND: Cleft defects are common craniofacial malformations which require early surgical repair. These patients are at high risk of postoperative airway obstruction and respiratory failure. Cleft surgery may require high doses of opioids which may contribute to these complications. OBJECTIVES: To compare the effectiveness of proximal and distal approaches to blocking the maxillary nerve in patients undergoing cleft lip or cleft palate surgery. DESIGN: Randomised, controlled and double-blind study. SETTING: The current study was carried out in Guwahati (Assam, India) between April 2014 and June 2014. PATIENTS: A total of 114 patients older than 6 months who underwent cleft lip or cleft palate surgery were included. Exclusion criteria included coagulation disorders, peripheral neuropathy or chronic pain syndrome, infection in the puncture site, allergy to local anaesthetics, lack of consent and language problems or other barriers that could impede the assessment of postoperative pain. INTERVENTIONS: Patients were randomly assigned to one of two groups: proximal group (bilateral suprazygomatic maxillary nerve blocks) and distal group (bilateral infraorbital nerve blocks for cleft lip repair and bilateral greater and lesser palatine nerve blocks and nasopalatine nerve block for cleft palate surgery). MAIN OUTCOME MEASURE: The primary endpoint was the percentage of patients requiring extra doses of opioids. Secondary endpoints included pain scores, respiratory and nerve block-related complications during the first 24 h. RESULTS: In the intra-operative period, there was a significant reduction of nalbuphine consumption in the proximal group (9.1 vs. 25.4%, P = 0.02). The percentage of patients requiring intra-operative fentanyl was lower in the proximal group (16.4 vs. 30.5%, P = 0.07). There were no differences in either postoperative pain scores or in postoperative complications. No technical failure or block-related complications were reported. CONCLUSION: Bilateral suprazygomatic maxillary nerve block is an effective and safe alternative to the traditional peripheral nerve blocks for cleft lip and cleft palate surgery, in a mixed paediatric and adult population.

Maternal anaesthesia in open and fetoscopic surgery of foetal open spinal neural tube defects: A retrospective cohort study.

BACKGROUND: Prenatal myelomeningocele repair by open surgery can improve the neurological prognosis of children with this condition. A shift towards a fetoscopic approach seems to reduce maternal risks and improve obstetric outcomes. OBJECTIVE: The aim of this study was to report on the anaesthetic management of women undergoing prenatal open or fetoscopic surgery for neural tube defects. DESIGN: A retrospective cohort study. SETTING: Prenatal myelomeningocele repair research group, Vall d'Hebron University Hospital, Spain. INTERVENTION: Intra-uterine foetal repairs of spina bifida between 2011 and 2016 were reviewed. Anaesthetic and vasoconstrictor drugs, fluid therapy, maternal haemodynamic changes during surgery, blood gas changes during CO2 insufflation for fetoscopic surgery, and maternal and foetal complications were noted. RESULTS: Twenty-nine foetuses with a neural tube defect underwent surgery, seven (24.1%) with open and 22 (75.9%) with fetoscopic surgery. There were no significant differences in maternal doses of opioids or neuromuscular blocking agents. Open surgery was associated with higher dose of halogenated anaesthetic agents [maximum medium alveolar concentration (MAC) sevoflurane 1.90 vs. 1.50%, P = 0.01], higher need for intra-operative tocolytic drugs [five of seven (71.4%) and two of 22 (9.1%) required nitroglycerine, P = 0.001], higher volume of colloids (500 vs. 300 ml, P = 0.036) and more postoperative tocolytic drugs (three drugs in all seven cases (100%) of open and in one of 21 (4.76%) of fetoscopic surgery, P < 0.001). Median mean arterial pressure was lower in open than in fetoscopic surgery. SBP, DBP and mean blood pressure decreased during uterine exposure, and this descent was more acute in open surgery. Use of vasoconstrictor drugs was related to the time of uterine exposure, but not to surgical technique. Blood gas analysis was not affected by CO2 insufflation during fetoscopic surgery. CONCLUSION: Open surgery was associated with more maternal haemodynamic changes and higher doses of halogenated anaesthetic and tocolytics agents than fetoscopic surgery.

Incidence and timing of hypotension after transcervical carotid artery stenting: correlation with postoperative complications.

OBJECTIVES: To assess the incidence and timing of hypotension after carotid artery stenting (CAS) and its correlation with postoperative complications. BACKGROUND: CAS-associated postoperative hypotension has been linked to surgical morbidity and mortality, especially to stroke and cardiac complications. METHODS: Ninety-seven consecutive patients undergoing transcervical CAS were monitored for at least 12 hr after operation. Hypotension was defined as systolic blood pressure < 90 mm Hg. Patients were divided into three groups: normal blood pressure and early (≤6 hr) and late (>6 hr) hypotension. Complications were recorded. RESULTS: Hypotension occurred in 34% of the patients (early hypotension in 63% of them). Hypotension was recorded in 21.6% of patients during surgery and in 21.6%, 15.5%, and 1.0% at 6, 12, and 24 hr postoperatively. Bradycardia occurred in 26.8% during operation and in 25.8%, 13.4%, and 10.3% at 6, 12, and 24 hr after surgery. Intraoperative bradycardia (P = 0.01) and hypotension (P = 0.02) were predictors of postoperative hypotension. The overall rate of complications was 5% without differences between the study groups. The mean length of stay was 3, 3.6, and 2.8 days in the normotensive, early hypotension, and late hypotension groups, respectively. CONCLUSIONS: Most postoperative hypotension episodes occurred within the first 6 hr, and more than one-third between the 6 and 12 hr post-procedure. All patients with late hypotension were asymptomatic. There was no difference in complications between the study groups. In patients undergoing ambulatory CAS, hemodynamic monitoring in the postoperative period is particularly important during the first 12 hr.

Postreperfusion Syndrome in Patients Receiving Vasoactive Drugs During Liver Graft Reperfusion.

OBJECTIVES: The most widely used definition of postreperfusion syndrome in liver transplant is a 30% decrease in mean arterial pressure during the first 5 minutes after vascular unclamping. With these criteria, increased postoperative morbidity has been reported. Vasoactivedrugs couldpreventthis syndrome.Themain objective of our study was to determine the incidence and complications associated with postreperfusion syndrome inpatientswho receivedvasoactive support. MATERIALS AND METHODS: We studied 246 patients who received norepinephrine infusions to maintain mean arterial pressure ≥60 mm Hg and who were monitored with a Swan-Ganz catheter. Patients received a bolus of adrenaline after vascular unclamping in cases of insufficient response to norepinephrine. RESULTS: Among the study patients, 57 (23.17%) developed postreperfusion syndrome. Patients who developed postreperfusion syndrome did not present with morepostoperative complications interms ofrenal dysfunction (P = .69), repeat surgery (P = .15), graft rejection (P = .69), transplant replacement surgery (P = .76), hospital stay (P = .70), or survival (P = .17) compared with patients without postreperfusion syndrome. CONCLUSIONS: In patients who underwent orthotopic liver transplant, in whom vasoactive drugs were administered, a diagnosis of self-limited postreperfusion syndrome during the first 5 minutes after unclamping may not be associated with postoperative complications. The administration of vasoconstrictors may have a preventive effect on the postoperative complications associated with postreperfusion syndrome or they may mask the real incidence of postreperfusion syndrome. A broader definition of postreperfusion syndrome should be accepted.

Validation and cross-cultural adaptation of the postoperative quality of recovery 15 (QoR-15) questionnaire for Spanish-speaking patients: A prospective cohort study.

BACKGROUND: The postoperative QoR-15 questionnaire may improve the detection of postoperative complications on an early basis and contribute to optimize treatment and recovery. No validated Spanish QoR-15 questionnaire has been available to date. METHODS: The Spanish QoR-15 questionnaire (QoR-15E), carried out by official bilingual translators, was administered to 242 adult patients undergoing elective surgery before and 24 h after surgery. Patients were asked about their perceived quality of general recovery using a visual analogue scale (VAS). A random subgroup of 36 patients completed a third questionnaire 30-60 min after having completed the first one, and under the same conditions. RESULTS: The Pearson correlation coefficient between QoR-15E and the VAS score was 0.759. Cronbach's alpha was 0.856 in the postoperative period. Reliability by the split-half method was 0.781. Test-retest correlation coefficient was 0.998. Cohen's d was 0.94. The mean time to complete the preoperative questionnaire was 2.9 ± 0.5 min. CONCLUSIONS: The QoR-15E is valid and reliable for assessing postoperative quality of recovery in Spanish-speaking patients, with psychometric and interpretative features similar to those of the original instrument.

Comparison of cerebral metabolic rate of oxygen, blood flow, and bispectral index under general anesthesia.

Significance: The optical measurement of cerebral oxygen metabolism was evaluated. Aim: Compare optically derived cerebral signals to the electroencephalographic bispectral index (BIS) sensors to monitor propofol-induced anesthesia during surgery. Approach: Relative cerebral metabolic rate of oxygen ( rCMRO 2 ) and blood flow (rCBF) were measured by time-resolved and diffuse correlation spectroscopies. Changes were tested against the relative BIS (rBIS) ones. The synchronism in the changes was also assessed by the R-Pearson correlation. Results: In 23 measurements, optically derived signals showed significant changes in agreement with rBIS: during propofol induction, rBIS decreased by 67% [interquartile ranges (IQR) 62% to 71%], rCMRO 2 by 33% (IQR 18% to 46%), and rCBF by 28% (IQR 10% to 37%). During recovery, a significant increase was observed for rBIS (48%, IQR 38% to 55%), rCMRO 2 (29%, IQR 17% to 39%), and rCBF (30%, IQR 10% to 44%). The significance and direction of the changes subject-by-subject were tested: the coupling between the rBIS, rCMRO 2 , and rCBF was witnessed in the majority of the cases (14/18 and 12/18 for rCBF and 19/21 and 13/18 for rCMRO 2 in the initial and final part, respectively). These changes were also correlated in time ( R > 0.69 to R = 1 , p - values < 0.05 ). Conclusions: Optics can reliably monitor rCMRO 2 in such conditions.

Noise Levels and Sleep in a Surgical ICU.

Sleep is disturbed in critically ill patients and is a frequently overlooked complication. The aim of our study is to evaluate the impact of sound levels in our surgical ICU on our patients' sleep on the first night of admission. The study was performed in a tertiary care university hospital, in a 12-bed surgical ICU. Over a 6-week period, a total of 148 adult, non-intubated and non-sedated patients completed the study. During this six-week period, sound levels were continuously measured using a type II sound level meter. Sleep quality was evaluated using the Richards-Campbell Sleep Questionnaire (RCSQ), which was completed both by patients and nurses on the first morning after admission. A non-significant correlation was found between night sound levels and sleep quality in the overall sample (r = -1.83, 95% CI; -4.54 to 0.88, p = 0.19). After multivariable analysis, a correlation was found between higher sound levels at night and lower RCSQ evaluations (r = -3.92, 95% CI; -7.57 to -0.27, p = 0.04). We found a significant correlation between lower sound levels at night and a better quality of sleep in our patients; for each 1 dBA increase in LAFeq sound levels at night, patients scored 3.92 points lower on the sleep questionnaire.

Planning for the assistance of critically ill patients in a Pandemic Situation: The experience of Vall d'Hebron University Hospital.

INTRODUCTION: In the context of community transmission of the virus, the impact of the pandemic on health-care systems, mainly on intensive care units (ICU), was expected to be devastating. Vall d'Hebron University Hospital (HUVH) implemented an unprecedented critical patient-care planning and management of resources. METHODS: We describe a cohort of critically ill patients during the first two months of the pandemic (from March 3, 2020, to May 2, 2020) in HUVH, Barcelona. In this manuscript, we report our previsions, strategies implemented, and the outcomes obtained. RESULTS: Three-thousand and thirty-three patients were admitted to the HUVH Critical Care Units. Throughout the study period, the proportion of patients on IMV or IMV and ECMO remained above 78%. Most patients were men (65%); the most common age group was 60-70 years. Twenty-three patients received ECMO, and eighteen were cannulated at another center and transferred to HUVH. At the end of the study, fourteen patients were successfully decannulated, three patients died, and the rest of the patients were still on ECMO. Eight pregnant women have been treated in the ICU, with a survival rate of 100%. The ICU mortality of patients younger than 60 years was 3.2%. The mean ICU stay of both survivors and nonsurvivors was 14 days. CONCLUSION: The adequate preparation for resource expansion for critically ill patients care, main challenges, and overall positive results can serve as a precedent for similar future scenarios.

Mortality and bleeding complications of COVID-19 critically ill patients with venous thromboembolism.

BACKGROUND: Venous thromboembolism (VTE) disease in COVID-19 patients is a remarkable issue, especially its relationship with bleeding events and mortality. The objective of this study was to describe the outcomes of critically ill patients with COVID-19, hospitalized in the Intensive Care Unit (ICU), in relationship with VTE during their stay. METHODS: This is a prospective cohort study of critically ill COVID-19 patients in two hospitals that underwent a venous ultrasound at the beginning of follow-up of both lower limbs in April 2020. In case of clinical suspicion of new VTE during the 30-day follow-up, additional ultrasound or thoracic CT were performed. Global VTE frequency, major bleeding events and survival were collected, and their predictors were studied. RESULTS: We included 230 patients. After 30 days of follow-up, there were 95 VTE events in 86 patients (37.4%). Thirteen patients (5.7%) developed major bleeding complications and 42 patients (18.3%) died. None of the comorbidities or previous treatments were related with bleeding events. D-Dimer at admission was significantly related with VTE development and mortality. Independent predictors of mortality in the regression model were older age (>66 years), D-Dimer at admission (>1.500 ng/mL) and low lymphocyte count (<0.45×109/L) with an AUC in the ROC curve of 0.81 (95% CI: 0.73-0.89). Patients presenting these three conditions presented a mortality of 100% in the predictive model. CONCLUSIONS: VTE frequency in ICU COVID-19 patients is high and risk of major bleeding is low. Comorbidities and laboratory parameters of admission in these patients can be a useful tool to predict mortality.

Study protocol for an observational cohort evaluating incidence and clinical relevance of perioperative elevation of high-sensitivity troponin I and N-terminal pro-brain natriuretic peptide in patients undergoing lung resection.

INTRODUCTION: Myocardial injury after non-cardiac surgery has been defined as myocardial injury due to ischaemia, with or without additional symptoms or ECG changes occurring during or within 30 days after non-cardiac surgery and mainly diagnosed based on elevated postoperative cardiac troponin (cTn) values. In patients undergoing thoracic surgery for lung resection, only postoperative cTn elevations are seemingly not enough as an independent predictor of cardiovascular complications. After lung resection, troponin elevations may be regulated by mechanisms other than myocardial ischaemia. The combination of perioperative natriuretic peptide measurement together with high-sensitivity cTns may help to identify changes in ventricular function during thoracic surgery. Integrating both cardiac biomarkers may improve the predictive value for cardiovascular complications after lung resection. We designed our cohort study to evaluate perioperative elevation of both high-sensitivity troponin I (hs-TnI) and N-terminal pro-brain natriuretic peptide (NT-proBNP) in patients undergoing lung resection and to establish a risk score for major cardiovascular postoperative complications. METHODS AND ANALYSIS: We will conduct a prospective, multicentre, observational cohort study, including 345 patients undergoing elective thoracic surgery for lung resection. Cardiac biomarkers such as hs-TnI and NT-proBNP will be measured preoperatively and at postoperatively on days 1 and 2. We will calculate a risk score for major cardiovascular postoperative complications based on both biomarkers' perioperative changes. All patients will be followed up for 30 days after surgery. ETHICS AND DISSEMINATION: All participating centres were approved by the Ethics Research Committee. Written informed consent is required for all patients before inclusion. Results will be disseminated through publication in peer-reviewed journals and presentations at national or international conference meetings. TRIAL REGISTRATION NUMBER: NCT04749212.