Complications of intravascular catheters in ICU: definitions,incidence and severity. A randomized controlled trial comparing usual transparent dressings versus new-generation dressings (the ADVANCED study)

Purpose

To describe all post-insertion complications involving most used intravascular access, and to determine whether the use of a new-generation transparent dressing (3M? IV Advanced) might reduce their number and impact on ICU patient outcomes.

Methods

Patients older than 18, with an expected length of stay ≥48 h and requiring at least one central venous catheter (CVC), arterial catheter (AC), haemodialysis catheter (HDC), pulmonary arterial catheters (PAC) or peripheral venous catheter (PVC) were randomized into two groups: a new-generation transparent dressing, or the hospital’s classical transparent dressing, and were followed daily for any infectious and non-infectious complications. Complications were graduated for severity by an independent international multicentre multidisciplinary panel of practitioners using a Delphi process.

Results

We included 628 patients, 2214 catheters (873 PVCs, 630 CVCs, 512 ACs and 199 HDCs and PACs) and 4836 dressings. Overall incidence rate was of 60.9/1000 catheter-days. The most common complication was dysfunction (34.6/1000 catheter-days), mainly for PVCs (16/1000 catheter-days) and ACs (12.9/1000 catheter-days). Infectious complications incidence rate in CVCs and ACs was of 14.5/1000, mostly due to colonization (14.2/1000 catheter-days). Thrombosis incidence was of 3.8/1000 catheter-days with severe and very severe complications in 16 cases (1.8/1000 catheter-days) and one thrombosis-related death. 3M? IV Advanced dressing did not decrease the rate of catheters with at least a minor complication [57.37/1000 vs. 57.52/1000 catheter-days, HR 1.03, CI (0.84–1.27), p = 0.81]. Incidence rates for each single complication remained equivalent: infectious [HR 0.93 (0.62–1.40), p = 0.72], deep thrombosis [HR 0.90 (0.39–2.06), p = 0.80], extravasation and phlebitis [HR 1.40 (0.69–2.82), p = 0.35], accidental removal [1.07 (0.56–2.04), p = 0.84] and dysfunction [HR 1.04 (0.80–1.35), p = 0.79].

Conclusion

The ADVANCED study showed the overall risk of complications to intravascular catheters in ICU patients being dysfunction, infection and thrombosis. The 3M? IV Advanced dressing did not decrease complication rates as compared to standard dressings.

     

Associations between increased renal resistive index and cardiovascular events

Background and purpose

Chronic kidney disease is a risk factor for cardiovascular disease (CVD). Renal resistive index (RI) measured by Doppler ultrasonography is associated with renal impairment. We investigated the relationship between RI and cardiac function, and evaluated the utility of RI for predicting cardiac events in patients with CVD.

Methods and results

Renal Doppler ultrasonography and echocardiography were performed in a total of 452 patients with CVD. Correlations of RI with serum creatinine and estimated glomerular filtration rate (eGFR) were significant but not strong (r = 0.37, p < 0.001; r = ?0.42, p < 0.001, respectively). RI correlated positively with age, left atrial volume index, left ventricular mass index, and early transmitral velocity to mitral annular early diastolic velocity (e′) ratio (E/e′), and showed significant negative correlations with e′ and diastolic blood pressure. Between two subgroups—112 patients hospitalized with cardiovascular events (Group A) and 200 age- and eGFR-matched controls (Group B)—RI was significantly higher in Group A than in Group B, although age and eGFR were similar.

Conclusions

RI reflects the impairment of intrarenal hemodynamics that cannot be adequately elucidated by eGFR alone. Assessment of renal RI may be useful in conjunction with prognostic estimates for patients with CVD.

     

Impact of hysterectomy on three-dimensional rectosigmoid morphology and endoscopy performance: a pilot study

Objectives

Assess differences in three-dimensional colonic metrics on CTC in women with or without hysterectomy following incomplete endoscopy to determine if there is a correlation between colonic morphology and incomplete colonoscopy after hysterectomy.

Methods

Quantitative rectosigmoid metrics were derived from CTC datasets of 37 women with hysterectomy and 36 women without hysterectomy who underwent CTC for incomplete endoscopy. Evaluated metrics included colonic length, volume, tortuosity, and compactness and sigmoid apex height relative to the lumbosacral junction. Differences were measured using the Student’s t test, and intra-reader reliability was assessed using ICC. The relative risk of incomplete rectosigmoid visualization was determined by reviewing the endoscopy reports.

Results

Women with hysterectomy had a lower sigmoid apex height (p = 0.002), as well as increased tortuosity (p = 0.012) and compactness (p = 0.001) and decreased length (p = 0.026) and volume (p = 0.016) of the rectosigmoid. Intra-reader reliability was high for centerline length (ICC = 0.9940) and sigmoid apex height (ICC = 0.9851). The relative risk of incomplete visualization of the rectosigmoid on endoscopy in women with hysterectomy was 2.068 (p = 0.043) compared to women without hysterectomy.

Conclusion

Our pilot data show reproducible quantitative differences in three-dimensional metrics of the rectosigmoid in women with or without hysterectomy who underwent CTC for incomplete endoscopy and increased relative risk of incomplete endoscopic visualization of the rectosigmoid after hysterectomy. Our findings suggest that women with hysterectomy may benefit from CTC rather than endoscopy as the initial diagnostic test for evaluating the colon.

     

Efficacy of the echo pattern classification of ovarian tumors 2000 in conjunction with transvaginal ultrasonography for diagnosis of ovarian masses

Purpose

Because of the need for rapid, accurate clinical differentiation between malignant and benign ovarian masses, we investigated the diagnostic efficacy of the echo pattern classification used together with transvaginal ultrasound.

Methods

We classified, on the basis of six echo pattern types, transvaginal ultrasound images of 405 ovarian masses treated surgically between January 2011 and December 2012. We compared the resulting classifications to the postoperative histopathologic diagnoses and computed the diagnostic sensitivity and specificity of the echo pattern-based classification for malignancy.

Results

Our review yielded the following echo patterns: type I, n = 61; type II; n = 154; type III, n = 82; type IV, n = 61; type V, n = 34; and type VI, n = 13. Histopathologically, there were 75 borderline malignant/malignant tumors and 330 benign tumors. Diagnostic sensitivity was 80.0 % and specificity was 85.5 % when echo types I–III were categorized as benign and types IV–VI were categorized as malignant. Further, with respect to benign tumors: sensitivity and specificity for chocolate cysts were 85.5 and 88.4 %, respectively, and for dermoid cysts were 67.2 and 97.9 %, respectively.

Conclusions

With the echo pattern classification, ovarian masses can be diagnosed easily and accurately upon transvaginal ultrasound.

     

Histogram analysis of noncancerous liver parenchyma on gadoxetic acid-enhanced MRI: predictive value for liver function and pathology

Purpose

To clarify whether the heterogeneity of hepatic parenchyma in the hepatobiliary phase on gadoxetic acid-magnetic resonance (MR) imaging is correlated with liver damage.

Materials and methods

We retrospectively examined the cases of 98 patients with or without chronic liver disease who underwent gadoxetic acid-enhanced 3T MR imaging before a hepatectomy between December 2010 and October 2014. For the evaluation of the heterogeneity of the signal intensity in the hepatobiliary phase, we placed the region of interest on the hepatic parenchyma, and the skewness and kurtosis were calculated using ImageJ software. A discriminant analysis was performed to examine the routine preoperative laboratory test results including indocyanine green retention at 15 min (ICG-R15), necro-inflammation grade, and liver fibrosis stage according to the METAVIR system: A0/1 (n = 69) and A2 (n = 29); F0/1 (n = 47), F2/3 (n = 31), and F4 (n = 20).

Results

The combination of skewness and kurtosis could discriminate the high ICG-R15 (>20) and low (<20) groups (lambda; 0.925, p = 0.025), necro-inflammatory grade (lambda; 0.926, p = 0.026), and fibrosis stage (lambda; 0.752, p < 0.0001) with statistical significance. The difference between the patients with normal values and those with an abnormal platelet count or aspartate transaminase level was also detectable (lambda; 0.901, p < 0.007, and lambda; 0.864, p = 0.001, respectively).

Conclusion

Histogram analyses of the hepatobiliary phase of gadoxetic acid-enhanced MR imaging have potential as a biomarker for the assessment of liver function, liver fibrosis, and necro-inflammation.

     

Small (&lt;4 cm) clear cell renal cell carcinoma: correlation between CT findings and histologic grade

Purpose

To evaluate the correlation between CT findings and histologic grade of small clear cell renal cell carcinoma (ccRCC).

Methods

CT scans of 101 patients with small ccRCC were reviewed independently by two radiologists for tumor size, shape, margin, encapsulation, enhancement pattern, and visual relative enhancement. Enhancement patterns were defined according to the percentage of uniform enhancement [pattern 1, homogeneous (≥90%); pattern 2, relatively homogeneous (≥75 and <90%); and pattern 3, heterogeneous (<75%)]. Quantitative parameters representing attenuation and degree of enhancement were calculated. Histologic grade was classified as low (Fuhrman grade I or II) and high (Fuhrman grade III or IV). CT imaging variables were analyzed using univariate and multivariate analyses.

Results

A total of 63 low-grade and 38 high-grade small ccRCCs were assessed. Low-grade tumors differed from high-grade tumors with respect to enhancement pattern 1 or 2 (p < 0.001 and p < 0.001), smaller size (p = 0.002 and p = 0.001), and lower attenuation on unenhanced scan (p < 0.001 and p = 0.008). In multivariate analysis, enhancement pattern 1 or 2 and low attenuation (≤30 HU) were identified as independent predictors of low-grade ccRCC. Accuracy derived from logistic regression analysis was 79.2% for reader 1 and 70.3% for reader 2.

Conclusions

CT imaging features including tumor attenuation and enhancement pattern can be useful to predict the biologic behavior of small ccRCC for adequate treatment strategy.

     

Ist Kinesiophobie während eines anhaltenden Schmerzzustands mit Lateralitäts- und Emotionserkennungsveränderungen assoziiert?

Background

The aim of this study is to investigate the effects of kinesiophobia on emotion recognition and left/right judgement.

Materials and methods

A total of 67 patients with chronic musculoskeletal pain were tested. In all, 24 patients achieved a score >37 on the Tampa Scale of Kinesiophobia and were included in the study. The ability to recognize basic emotions coded through facial expression was assessed using the Facially Expressed Emotion Labeling (FEEL) test. Left/right judgement was evaluated using a special Face-mirroring Assessment and Treatment program. The Toronto Alexithymia Scale-26 (TAS-26) was used to assess if the patients showed signs of alexithymia.

Results

The FEEL score of patients with kinesiophobia was significantly lower (p = 0.019). The recognition of the basic emotions fear (p = 0.026), anger (p = 0.027), and surprise (p = 0.014) showed significant differences in comparison to unaffected subjects. The basic emotion surprise was recognized more often by patients with kinesiophobia (p = 0.014). Only Scale 1 of the TAS-26 (identification problems of emotions) showed a significant difference between patients with kinesiophobia (p = 0.008) and healthy subjects.

Conclusion

The results show that kinesiophobic patients have altered recognition of emotions, problems in left/right judgement, and show signs of alexithymia.

     

Effect of steatosis on liver signal and enhancement on multiphasic contrast-enhanced magnetic resonance imaging

Purpose

To investigate the effect of steatosis on liver signal and enhancement in multiphasic contrast-enhanced (MCE) MRI.

Materials and methods

In this IRB-approved, HIPAA-compliant, retrospective, observational study, 1217 MCE abdominal MRIs performed during 2014 at a single institution were reviewed. Of these, 1085 were excluded, due to potential factors other than steatosis that may affect liver signal intensity and/or enhancement. In the remaining 132, liver fat fraction (FF) was calculated from the in- and opposed-phase 2D T1-weighted images. Liver signal intensity, absolute enhancement, and relative enhancement on fat-suppressed (Dixon method) 3D T1-weighted images before and after injection of gadobutrol (arterial, portal venous, and equilibrium phases) were plotted against co-localized FF values and the linear trend was evaluated by Pearson correlation coefficient (r). P values <0.05 were considered statistically significant.

Results

Liver signal intensity negatively correlated with FF for all phases (r = ?0.388 to ?0.544, p < 0.001). Absolute enhancement negatively correlated with FF for the portal venous and equilibrium phases (r = ?0.286 and ?0.289, respectively, p < 0.001), but not for the arterial phase (r = ?0.042, p = 0.632). Relative enhancement did not significantly correlate with FF for any phase (p ≥ 0.125).

Conclusion

Steatosis reduces liver signal intensity in MCE MRI. This effect of steatosis was reduced in calculated absolute enhancement and eliminated in calculated relative enhancement.

     

Effects of Tiotropium Combined with Theophylline on Stable COPD Patients of Group B,D and its Impact on Small Airway Function: A Randomized Controlled Trial

Introduction

Tiotropium bromide has been widely used in clinical practice, while theophylline is another treatment option for chronic obstructive pulmonary disease (COPD). However, only a few relevant studies have investigated the long-term outcomes and efficacy of both in patients with COPD. We evaluated the effects of tiotropium and low-dose theophylline on stable COPD patients of groups B and D.

Methods

Eligible participants (n?=?170) were randomized and received either tiotropium 18 µg once daily with theophylline 100 mg twice daily (Group I) or tiotropium 18 µg once daily (Group II) for 6 months. COPD assessment test (CAT), modified Medical Research Council (mMRC) dyspnea scores and pulmonary function tests were measured before randomization and during the treatment.

Results

After 6 months of treatment, the CAT scores in both groups decreased significantly (11.41?±?3.56 and 11.08?±?3.05, p?<?0.0001). The changes of CAT (p?=?0.028) and mMRC scores (p?=?0.049) between the two groups differed after 1 month of treatment. In Group I, forced expiratory flow after 25% of the FVC% predicted (MEF₂₅% pred) was significantly improved after 3 months (4.84?±?8.73%, p?<?0.0001) and 6 months (6.21?±?8.65%, p?<?0.0001). There was a significant difference in small airway function tests (MEF₅₀% pred, MEF₂₅% pred, and MMEF% pred) between the two groups after 6 month of treatment (p?=?0.003, p?<?0.0001, and p?=?0.021, respectively).

Conclusions

Tiotropium combined with low-dose theophylline significantly improved the symptoms and general health of patients with stable COPD of groups B and D after 6 months of follow-up. Additionally, this therapy also improved the indicators of small airway function.

Trial Registration

Chinese Clinical Trial Registry (Registry ID: ChiCTR1800019027).

     

Superselective transcatheter arterial embolization in patients with acute peripancreatic bleeding complications: review of 44 cases

Purpose

To evaluate the efficacy of superselective transcatheter arterial embolization (TAE) in the treatment of acute peripancreatic bleeding complications.

Methods

During a 9-year period, 44 patients with acute bleeding of the peripancreatic arteries underwent TAE in our institution. Thirty-eight patients were treated using microcatheters and 6 patients with a diagnostic catheter. Embolic agents included coils (n = 38), polyvinyl alcohol (PVA) particles (n = 2), isobutyl cyanoacrylate (n = 2), coils plus PVA particles (n = 1), and coils plus isobutyl cyanoacrylate (n = 1). Outcome measures included technical success, clinical success, and the rate of complications.

Results

Identified bleeding sources included gastroduodenal artery (n = 14), splenic artery (n = 9), pancreaticoduodenal artery (n = 6), common hepatic artery (n = 5), superior mesenteric artery branches (n = 4), proper hepatic artery (n = 3), and dorsal/transverse pancreatic artery (n = 3). Technical success with effective control of active bleeding was achieved in 41/44 patients (93 %). Clinical success attributed to TAE alone was documented in 40/44 patients (91 %). The rate of major complications was 2 % including death in one patient.

Conclusions

Superselective TAE allows effective, minimally invasive control of acute peripancreatic bleeding complications with a low rate of therapeutically relevant complications.

     

Correlation between the combination of apparent integrated backscatter–spectral centroid shift and bone mineral density

Purpose

To introduce a new diagnostic parameter: the linear combination of apparent integrated backscatter and spectral centroid shift.

Methods

Ultrasonic backscatter measurements were performed at the calcanei of 1262 volunteers in vivo. The hip and spine bone mineral densities of the volunteers were measured using dual X-ray absorptiometry. The apparent integrated backscatter and spectral centroid shift were calculated. A new diagnostic parameter, i.e., the linear combination of apparent integrated backscatter and spectral centroid shift, was introduced and its correlation to bone mineral density was analyzed.

Results

The results show that the combination of apparent integrated backscatter and spectral centroid shift is significantly correlated to bone mineral density (R = 0.73–0.84, n = 1262, p < 0.05), and that this correlation is more significant than the correlation between the apparent integrated backscatter and bone mineral density or the correlation between spectral centroid shift and bone mineral density (R = 0.48–0.69, p < 0.05).

Conclusion

The combination of apparent integrated backscatter and spectral centroid shift can provide the complementary information of attenuation of the two parameters and predict more information about cancellous bone, and may be employed to assess cancellous bone status.

     

Effects of restricting perioperative use of intravenous chloride on kidney injury in patients undergoing cardiac surgery: the LICRA pragmatic controlled clinical trial

Purpose

The administration of chloride-rich intravenous (IV) fluid and hyperchloraemia have been associated with perioperative renal injury. The aim of this study was to determine whether a comprehensive perioperative protocol for the administration of chloride-limited IV fluid would reduce perioperative renal injury in adults undergoing cardiac surgery.

Methods

From February 2014 through to December 2015, all adult patients undergoing cardiac surgery within a single academic medical center received IV fluid according to the study protocol. The perioperative protocol governed all fluid administration from commencement of anesthesia through to discharge from the intensive care unit and varied over four sequential periods, each lasting 5 months. In periods 1 and 4 a chloride-rich strategy, consisting of 0.9% saline and 4% albumin, was adopted; in periods 2 and 3, a chloride-limited strategy, consisting of a buffered salt solution and 20% albumin, was used. Co-primary outcomes were peak delta serum creatinine (?S_Cr) within 5 days after the operation and KDIGO-defined stage 2 or stage 3 acute kidney injury (AKI) within 5 days after the operation.

Results

We enrolled and analysed data from 1136 patients, with 569 patients assigned to a chloride-rich fluid strategy and 567 to a chloride-limited one. Compared with a chloride-limited strategy and adjusted for prespecified covariates, there was no association between a chloride-rich perioperative fluid strategy and either peak ?S _Cr, transformed to satisfy the assumptions of multivariable linear regression [regression coefficient 0.03, 95% confidence interval (CI) ?0.03 to 0.08); p = 0.39], or stage 2 or 3 AKI (adjusted odds ratio 0.97, 95% CI 0.65–1.47; p = 0.90].

Conclusions

A perioperative fluid strategy to restrict IV chloride administration was not associated with an altered incidence of AKI or other metrics of renal injury in adult patients undergoing cardiac surgery. Trial Registration: Clinicaltrials.gov Identifier: NCT02020538.

     

Zoomed echo-planar diffusion tensor imaging for MR tractography of the prostate gland neurovascular bundle without an endorectal coil: a feasibility study

Purpose

The purpose of this study was to assess the feasibility of zoomed echo-planar imaging (EPI) diffusion tensor imaging (DTI) with 2-channel parallel transmission (pTx) for MR tractography of the periprostatic neurovascular bundle (NVB) without an endorectal coil, and to compare its performance to that of conventionally acquired DTI.

Methods

8 healthy males (28.9 ± 4.6 years) underwent pelvic phased-array coil prostate MRI on a 3T system using both zoomed-EPI DTI (z-DTI) with 2-channel pTx and conventional single-shot spin-echo EPI DTI (c-DTI) acquisitions with 6 encoding directions and b-values of 0 and 1000 s/mm². Fractional anisotropy (FA) maps and tractography analysis incorporating 3D visualization of the NVB were performed from each acquisition. Fiber tract counts, estimated signal-to-noise ratio (eSNR), and image quality measures of the FA maps and NVB tractography were compared. Quantitative and image quality measures were compared using Wilcoxon signed rank tests.

Results

3 of 8 subjects had no tracts detected with c-DTI acquisition, while all 8 had tracts detected with z-DTI. z-DTI acquisition yielded significantly more fiber tracts (c-DTI: 77 ± 116 tracts; z-DTI: 430 ± 228 tracts; p = 0.019) and higher eSNR (c-DTI: 2.9 ± 1.2; z-DTI: 13.17 ± 9.9; p = 0.014). Relative to c-DTI acquisitions, z-DTI FA maps showed significantly reduced artifact (p = 0.008) and reduced anatomic distortion of the prostate (p = 0.010), while z-DTI tractography showed significantly better overall visual quality (p = 0.011), tract symmetry (p = 0.010), tract coherence (p = 0.011), and subjective similarity to the actual NVB (p = 0.011).

Conclusion

Zoomed-EPI DTI acquisition for tractography of the prostate gland NVB improves quantitative and qualitative measures of image and tract fiber quality, allowing tractography of the NVB at 3T without using an endorectal coil.

     

Critical care admission following elective surgery was not associated with survival benefit: prospective analysis of data from 27 countries

Purpose

As global initiatives increase patient access to surgical treatments, there is a need to define optimal levels of perioperative care. Our aim was to describe the relationship between the provision and use of critical care resources and postoperative mortality.

Methods

Planned analysis of data collected during an international 7-day cohort study of adults undergoing elective in-patient surgery. We used risk-adjusted mixed-effects logistic regression models to evaluate the association between admission to critical care immediately after surgery and in-hospital mortality. We evaluated hospital-level associations between mortality and critical care admission immediately after surgery, critical care admission to treat life-threatening complications, and hospital provision of critical care beds. We evaluated the effect of national income using interaction tests.

Results

44,814 patients from 474 hospitals in 27 countries were available for analysis. Death was more frequent amongst patients admitted directly to critical care after surgery (critical care: 103/4317 patients [2%], standard ward: 99/39,566 patients [0.3%]; adjusted OR 3.01 [2.10–5.21]; p < 0.001). This association may differ with national income (high income countries OR 2.50 vs. low and middle income countries OR 4.68; p = 0.07). At hospital level, there was no association between mortality and critical care admission directly after surgery (p = 0.26), critical care admission to treat complications (p = 0.33), or provision of critical care beds (p = 0.70). Findings of the hospital-level analyses were not affected by national income status. A sensitivity analysis including only high-risk patients yielded similar findings.

Conclusions

We did not identify any survival benefit from critical care admission following surgery.

     

Assessing anxiety in Black men with prostate cancer: further data on the reliability and validity of the Memorial Anxiety Scale for Prostate Cancer (MAX-PC)

Purpose

The National Cancer Institute has highlighted the need for psychosocial research to focus on Black cancer patients. This applies to Black men with prostate cancer, as there is little systematic research concerning psychological distress in these men. This study was designed to validate the Memorial Anxiety Scale for Prostate Cancer (MAX-PC) in Black men with prostate cancer to help facilitate research within this group.

Methods

At three institutions, Black men with prostate cancer (n = 101) completed the MAX-PC, the Hospital Anxiety and Depression Scale (HADS), the Functional Assessment of Cancer Therapy (FACT) Quality of Life Questionnaire, and the Distress Thermometer.

Results

The average age of the 101 men was 66 (SD = 10) and 58 % had early-stage disease. The MAX-PC and its subscales (Prostate Cancer Anxiety, PSA Anxiety, and Fear of Recurrence) produced strong coefficient alphas (0.89, 0.88, 0.71, and 0.77, respectively). Factor analysis supported the three-factor structure of the scale established in earlier findings. The MAX-PC also demonstrated strong validity. MAX-PC total scores correlated highly with the Anxiety subscale of the HADS (r = 0.59, p < 0.01) and the FACT Emotional Well-Being subscale (r = ?0.55, p < 0.01). Demonstrating discriminant validity, the correlation with the HADS Depression subscale (r = 0.40, p < 0.01) and the CES-D (r = 0.42, p < 0.01) was lower compared to that with the HADS Anxiety subscale.

Conclusions

The MAX-PC is valid and reliable in Black men with prostate cancer. We hope the validation of this scale in Black men will help facilitate psychosocial research in this group that is disproportionately adversely affected by this cancer.

     

A randomized clinical trial of ultrasound-guided infra-clavicular cannulation of the subclavian vein in cardiac surgical patients: short-axis versus long-axis approach

Purpose

The aim of this study was to compare the success rate and safety of short-axis versus long-axis approaches to ultrasound-guided subclavian vein cannulation.

Methods

A total of 190 patients requiring central venous cannulation following cardiac surgery were randomized to either short-axis or long-axis ultrasound-guided cannulation of the subclavian vein. Each cannulation was performed by anesthesiologists with at least 3 years’ experience of ultrasound-guided central vein cannulation (>150 procedures/year, 50% short-axis and 50% long-axis). Success rate, insertion time, number of needle redirections, number of separate skin or vessel punctures, rate of mechanical complications, catheter misplacements, and incidence of central line-associated bloodstream infection were documented for each procedure.

Results

The subclavian vein was successfully cannulated in all 190 patients. The mean insertion time was significantly shorter (p = 0.040) in the short-axis group (69 ± 74 s) than in the long-axis group (98 ± 103 s). The short-axis group was also associated with a higher overall success rate (96 vs. 78%, p < 0.001), first-puncture success rate (86 vs. 67%, p = 0.003), and first-puncture single-pass success rate (72 vs. 48%, p = 0.002), and with fewer needle redirections (0.39 ± 0.88 vs. 0.88 ± 1.15, p = 0.001), skin punctures (1.12 ± 0.38 vs. 1.28 ± 0.54, p = 0.019), and complications (3 vs. 13%, p = 0.028).

Conclusions

The short-axis procedure for ultrasound-guided subclavian cannulation offers advantages over the long-axis approach in cardiac surgery patients.

     

A Randomized Trial Investigating the Pharmacokinetics,Pharmacodynamics, and Safety of Subcutaneous Semaglutide Once-Weekly in Healthy Male Japanese and Caucasian Subjects

Introduction

Semaglutide is a glucagon-like peptide-1 analogue for once-weekly subcutaneous treatment of type 2 diabetes. This trial compared the pharmacokinetics, pharmacodynamics, and safety of semaglutide in Japanese and Caucasian subjects.

Methods

In this single-center, double-blind, parallel-group, 13-week trial, 44 healthy male subjects (22 Japanese, 22 Caucasian) were randomized within each race to semaglutide 0.5 mg (n = 8), 1.0 mg (n = 8), placebo 0.5 mg (n = 3) or 1.0 mg (n = 3). The primary endpoint was semaglutide exposure at steady state [area under the curve (AUC_0–168h)].

Results

Steady-state exposure of semaglutide was similar for both populations: AUC_0–168h estimated race ratio (ERR), Japanese/Caucasian: 0.5 mg, 1.06; 1.0 mg, 0.99; maximum concentration (C_max) ERR: 0.5 mg, 1.06; 1.0 mg, 1.02. Exposure after the first dose (0.25 mg) was slightly higher in Japanese versus Caucasian subjects (AUC_0–168h ERR 1.11; C_max ERR 1.14). Dose-dependent increases in AUC_0–168h and C_max occurred in both populations. Accumulation was as expected, based on the half-life (t_1/2, ~ 1 week) and dosing interval of semaglutide. Significant body weight reductions were observed with semaglutide 0.5 mg and 1.0 mg in Japanese (both p ≤ 0.05) and Caucasian (both p ≤ 0.05) subjects versus placebo. No new safety issues were identified.

Conclusions

The pharmacokinetic, pharmacodynamic, and safety profiles of semaglutide were similar in Japanese and Caucasian subjects, suggesting that no dose adjustment is required for the clinical use of semaglutide in Japanese subjects.

Funding

Novo Nordisk A/S, Denmark.

Trial registration

ClinicalTrials.gov identifier NCT02146079. Japanese trial registration number JapicCTI-142550.

     

FLT-PET/CT diagnosis of primary and metastatic nodal lesions of gastric cancer: comparison with FDG-PET/CT

Purpose

To examine the diagnostic performance of ¹⁸F-fluorothymidine (FLT)-PET/CT of primary and metastatic nodal lesions of gastric cancer by comparing with ¹⁸F-fluorodeoxyglucose (FDG)-PET/CT.

Methods

The enrolled study population comprised 17 patients with 17 newly diagnosed gastric cancers who underwent surgery of the primary lesion and regional nodes after both FDG- and FLT-PET/CT scans. Visual detectability of the primary gastric lesions was correlated with pathological factors using the Fisher exact or Mann–Whitney U test. The sensitivity, specificity, and accuracy in detecting nodal lesions were compared between both PET/CT scans using the McNemar exact or χ ² test.

Results

Fourteen of 17 (82.4%) primary cancers were visualized by both FDG- and FLT-PET/CT scans. Although FDG or FLT visibility was not significantly associated with tumor size (p = 0.16) or histological type (p = 1.00), the 3 nonvisible lesions were pathologically early (T1) cancers. The sensitivity, specificity, and accuracy for detecting nodal metastasis were 44.8% (13/29), 98.7% (164/166), and 90.8% (177/195) for FDG-PET/CT, and 31.0% (9/29), 100% (166/166), and 89.7% (175/195) for FLT-PET/CT, respectively. No significant difference was found between the two scans in sensitivity (p = 0.13), specificity (p = 0.48), or accuracy (p = 1.00).

Conclusion

FLT-PET/CT may have the same diagnostic value as FDG-PET/CT for detection of primary and nodal lesions of gastric cancer.

     

Nitric oxide administration during paediatric cardiopulmonary bypass: a randomised controlled trial

Purpose

Cardiopulmonary bypass induces an ischaemia–reperfusion injury and systemic inflammatory response, which contributes to low cardiac output syndrome following cardiac surgery. Exogenous nitric oxide during cardiopulmonary bypass has shown potential to ameliorate such injury. We undertook a large randomised controlled trial to investigate the clinical effects of administering nitric oxide to the cardiopulmonary bypass circuit in children.

Methods

After written informed consent, children were randomised to receive 20 ppm nitric oxide to the gas inflow of the cardiopulmonary bypass oxygenator, or standard conduct of bypass.

Results

101 children received nitric oxide and developed low cardiac output syndrome less frequently (15 vs. 31 %, p = 0.007) than the 97 children who did not receive nitric oxide. This effect was most marked in children aged less than 6 weeks of age (20 vs. 52 %, p = 0.012) and in those aged 6 weeks to 2 years (6 vs. 24 %, p = 0.026), who also had significantly reduced ICU length of stay (43 vs. 84 h, p = 0.031). Low cardiac output syndrome was less frequent following more complex surgeries if nitric oxide was administered (17 vs. 48 %, p = 0.018). ECMO was used less often in the nitric oxide group (1 vs. 8 %, p = 0.014).

Conclusions

Delivery of nitric oxide to the oxygenator gas flow during paediatric cardiopulmonary bypass reduced the incidence of low cardiac output syndrome by varying degrees, according to age group and surgery complexity.Clinical Trial Registration: ACTRN12615001376538.

     

Readout-segmented echo-planar imaging in diffusion-weighted imaging of the kidney: comparison with single-shot echo-planar imaging in image quality

Objective

The purpose of this study was to compare the image quality of readout-segmented echo-planar imaging (RS-EPI) and that of standard single-shot echo-planar imaging (SS-EPI) in the kidney in a rat model.

Materials and methods

Twelve Wistar rats undergoing MRI examinations were imaged with two diffusion-weighted (DW) imaging protocols: a standard SS-EPI and a new RS-EPI protocol, both with a 1.0 × 1.0 × 3.0 mm voxel. The two groups of diffusion-weighted images were independently scored on geometric distortion, image blurring, signal dropout, and the overall image quality by two radiologists. Signal-to-noise ratio (SNR) and apparent diffusion coefficient (ADC) were measured on both sequences. Inter-rater agreement (IRA) was evaluated by Fleiss kappa (κ) and inter-class correlation coefficient (ICC) statistics. Comparisons of image qualities were made by Wilcoxon signed-rank test and paired-sample t test.

Results

Both RS-EPI and SS-EPI had good IRAs in scoring image qualities (κ = 0.607–0.833) and measuring renal ADCs (ICC = 0.828–0.945). Compared to SS-EPI, RS-EPI produced less geometric distortion (median score 1.5 versus 2.5, p < 0.0001), less image blurring (1.75 versus 2.0, p = 0.0003), less signal dropout (1.0 versus 3.0, p = 0.0001), and a lower score in overall image artifacts (4.25 versus 7.25; p < 0.0001). RS-EPI had higher SNR of renal DW images than SS-EPI (p < 0.001). The intra-variability of ADCs in cortex, outer medulla, and inner medulla ranged from 9.6 % to 11.1 % (Pearson correlation coefficient ρ = 0.675–0.729; p < 0.001) between the two protocols.

Conclusion

We showed that for DWI of the kidney at 1.0 × 1.0 × 3.0 mm³ voxel sizes, the new protocol provided better image quality than standard SS-EPI protocol.