Complications and risk factors on midline catheters’ follow-up about non-ICU patients: study protocol for a multicentre observational study (the midDATA study)

Introduction The midline catheter (MC) is an increasingly popular device used commonly for patients with difficult venous access or those who require infusion for more than 6 days. Little is known about complications such as infection, thrombosis or occlusion for inpatient and home care patient. This protocol presents the follow-up of non-intensive care unit patients with an MC. The aim is to identify complications and search for risk factors associated with these complications.Method and analysis A prospective observational design is used for the follow-up of 2000 patients from 13 centres in France. Each practitioner (inserting clinician, anaesthetist nurse, hospital nurse and home nurse) will fill out a logbook to report each care made (eg, number of saline flushes, dress maintenance) on the MC and if any complications occurred. The incidence of complications (ie, infections, thrombosis or occlusions) will be expressed by the total number of events per 1000 catheter days. The period of recruitment began in December 2019 for a duration of 2 years. An extension of the inclusion period of 1 year was obtained.Ethics and dissemination This study received the approval of the Committee for the Protection of Persons of Nord Ouest IV (No EudraCT/ID-RCB : 2019-A02406-51). It was registered at clinical trials (NCT04131088). It is planned to communicate results at conferences and in a peer-reviewed journal.Trial registration number NCT04131088

Évaluation d’un parcours de soin chez la femme au décours d’une prééclampsie

International audienceThe aim of our study was to investigate whether prepregnancy underweight body mass index (BMI) is associated with preterm birth (PTB) and small-for-gestational age (SGA). This retrospective case-control study included 814 women with live singleton fetuses in vertex presentation that gave birth between January 2016 and November 2016 in two tertiary care hospitals. The study group (n = 407) comprised all women whose prepregnancy BMI was underweight (<18.5 kg/m2) and who delivered during the study period. A control group (n = 407) was established with women whose prepregnancy BMI was normal (18.5–24.9 kg/m2) by matching age and parity. Univariate and multivariate analyses were performed to compare PTB and SGA associated with prepregnancy underweight BMI. Compared with the control group, the study group had higher rates of overall PTB (10.1% vs. 5.7%, p = 0.02), iatrogenic PTB (4.2% vs. 1.5%, p = 0.02), and SGA (22.1% vs. 11.1%, p < 0.001). In a multivariable analysis, prepregnancy underweight BMI was associated with PTB (aOR 2.32, 95% CI 1.12–4.81) and with SGA (aOR 2.38, 95% CI 1.58–3.58). In singleton pregnancies, women’s prepregnancy underweight compared with normal BMI was associated with an increase in PTB and in SGA neonates. Identifying this specific high-risk group is pragmatic and practical for all physicians, and they should be aware about perinatal outcome among underweight women

Efficacy of serum procalcitonin to predict spontaneous preterm birth in women with threatened preterm labour: a prospective observational study

Abstract Background A hypothesis of preterm parturition is that the pathogenesis of spontaneous preterm birth (sPTB) may be associated with an inflammatory process. Based on this theory, we have hypothesized that an inflammatory biomarker, procalcitonin (PCT), may be a good predictive marker of sPTB at the admission for threatened preterm labour (TPL). The present study was aimed to investigate the association between serum PCT and sPTB in women with TPL and to evaluate whether PCT levels may predict sPTB in women with TPL within 7 or 14 days. Methods In a prospective observational laboratory-based study, women with singleton pregnancies, TPL between 24 and 36 weeks and intact membranes, were enrolled between January 2014 and June 2016. Participants received routine medical management of TPL (tocolysis with atosiban, antenatal corticosteroids, and biological tests at admission (C-reactive protein, white blood cell count, and PCT measured on electrochemiluminescence immunoassay)). The primary endpoint was sPTB before 37 weeks of gestation. The value of serum PCT levels to predict sPTB within 7 or 14 days were evaluated using receiver-operating curves (ROC) analysis. Results A total of 124 women were included in our study. PCT levels did not statistically differ between women with sPTB (n = 30, 24.2%) and controls (n = 94) (median in ng/mL [interquartile range]: 0.043 [0.02–0.07] compared to 0.042 [0.02–0.13], respectively; P = 0.56). PCT levels did not also statistically differ between women with sPTB within 7 days (n = 7, 5.6%) or 14 days (n = 12, 9.7%) after testing and controls. Moreover, subgroup analysis revealed no difference among PCT levels at admission between 24 and 28 weeks, between 28 and 32 weeks and over 32 weeks, and controls. On the basis of the receiver-operating characteristic curve, the highest sensitivity and specificity corresponded to a PCT concentration of 0.038 ng/mL, with poor predictive values for sPTB within 7 or 14 days. Conclusion Serum PCT was not relevant to predict sPTB within 7 or 14 days in women admitted with TPL between 24 and 36 weeks, and thus it is not a suitable biological marker to confirm the hypothesis of an inflammatory process associated with preterm parturition. Trial registration Clinicaltrials.gov (NCT01977079), Registered 24 October 2013

Impact of emergency physician performed ultrasound in the evaluation of adult patients with acute abdominal pain: a prospective randomized bicentric trial

Abstract Background Abdominal pain is common in patients visiting the emergency department (ED). The aim of this study was to assess the diagnostic contribution of point-of-care ultrasound (POCUS) in patients presenting to the ED with acute abdominal pain. Methods We designed an interventional randomized, controlled, open label, parallel-group, trial in two French EDs. We included adult patients presenting to the ED with acute abdominal pain. Exclusion criteria were a documented end-of-life, an immediate need of life-support therapy and pregnant or breast-feeding women. Patients were randomized in the experimental group (i.e., workup including POCUS) or control group (usual care). The primary objective of the study was to assess the added value of POCUS on diagnostic pathway in the ED, according to the diagnostic established a posteriori by an adjudication committee. The primary endpoint was the proportion of exact preliminary diagnosis between the 2 groups. The preliminary diagnosis made after clinical examination and biological results with POCUS (intervention arm) or without POCUS (usual care) was considered exact if it was similar to the adjudication committee diagnosis. Results Between June 2021 11th and June 2022 23th, 256 patients were randomized, but five were not included in the primary analysis, leaving 125 patients in the POCUS group and 126 patients in the usual care group (130 women and 121 men, median [Q1-Q3] age: 42 [30;57]). There was no difference for exact diagnosis between the two groups (POCUS 70/125, 56% versus control 78/126 (62%), RD 1.23 [95% CI 0.74–2.04]). There was no difference in the accuracy for the diagnosis of non-specific abdominal pain nor number of biological or radiological exams. Diagnostic delays and length of stay in the ED were also similar. Conclusions In this trial, systematic POCUS did not improve the rate of diagnostic accuracy in unselected patients presenting to the ED with acute abdominal pain. However, as it was a safe procedure, further research should focus on patients with suspected etiologies where POCUS is particularly useful. Trial registration: This trial was registered on ClinicalTrials.gov on 2022/07/20 ( https://clinicaltrials.gov/study/NCT04912206?id=NCT04912206&rank=1 ) (NCT04912206)

Functional and Survival Outcomes of Patients following the Harrington Procedure for Complex Acetabular Metastatic Lesions

Background: The Harrington surgical technique makes it possible to manage complex, extensive bone lesions using pins and cement to consolidate bone for acetabular cup positioning. However, it may be associated with a high reoperation rate, and the functional results of this surgery are not precisely described in the literature. Methods: In a monocentric retrospective study including all patients operated on using the Harrington procedure associated with THA between 2005 and 2020, we aimed to assess preoperative and postoperative function, reoperation-free survival, and overall survival. Results: Functional improvement was significant for Parker scores (preoperative: 3.6 ± 2.0; 6-month follow-up: 6.6 ± 3.2; 12-month follow-up: 7.6 ± 2.1) and Musculoskeletal Tumor Society (MSTS) scores (preoperative: 31.1 ± 16.2%; 6-month follow-up: 67.7 ± 30.6%; 12-month follow-up: 82.4 ± 24.0%). Of the 21 patients included, the reoperation-free survival rate was 76.1% [CI 95%: 58.1–99.7] at six and twelve months, with the main complications being pin migration (50.0%) and infection (25%). The patient overall survival rate was 76.2% [95% CI: 59.9–96.7] at six months and 61.9% [95% CI: 59.9–96.7] at 12 months. Discussion: These results underlined significant functional improvements following a conventional Harrington procedure, with acceptable reoperation rates

Combined Plasma Elevation of CRP, Intestinal-Type Fatty Acid-Binding Protein (I-FABP), and sCD14 Identify Older Patients at High Risk for Health Care-Associated Infections

International audienceBackground: We hypothesized that low-grade inflammation was driven by microbial translocation and associated with an increased risk of health care-associated infections (HAIs).Methods: We included 121 patients aged 75 years or over in this prospective cohort study. High-sensitivity C-reactive protein (hs-CRP), I-FABP, and sCD14-as markers for low-grade inflammation, intestinal epithelial barrier integrity, and monocyte activation, respectively-were measured at admission.Results: HAIs occurred during hospitalization in 62 (51%) patients. Elevated hs-CRP (≥6.02 mg/L, ie, the median) was associated with a significantly higher HAI risk when I-FABP was in the highest quartile (odds ratio [OR], 4; 95% confidence interval [95% CI], 1.39-11.49; p = .010). In patients with hs-CRP elevation and highest-quartile I-FABP, sCD14 elevation (≥0.65 µg/mL, ie, the median) was associated with an 11-fold higher HAI risk (OR, 10.8; 95% CI, 2.28-51.1; p = .003). Multivariate analyses adjusted for invasive procedures and comorbidities did not change the associations linking the three markers to the HAI risk.Conclusion: Increased levels of hs-CRP, I-FABP, and sCD14 may reflect loss of intestinal epithelial barrier integrity with microbial translocation leading to monocyte activation and low-grade inflammation. In our cohort, these markers identified patients at high risk for HAIs

Combined Plasma Elevation of CRP, Intestinal-Type Fatty Acid-Binding Protein (I-FABP), and sCD14 Identify Older Patients at High Risk for Health Care-Associated Infections

International audienceBackground: We hypothesized that low-grade inflammation was driven by microbial translocation and associated with an increased risk of health care-associated infections (HAIs).Methods: We included 121 patients aged 75 years or over in this prospective cohort study. High-sensitivity C-reactive protein (hs-CRP), I-FABP, and sCD14-as markers for low-grade inflammation, intestinal epithelial barrier integrity, and monocyte activation, respectively-were measured at admission.Results: HAIs occurred during hospitalization in 62 (51%) patients. Elevated hs-CRP (≥6.02 mg/L, ie, the median) was associated with a significantly higher HAI risk when I-FABP was in the highest quartile (odds ratio [OR], 4; 95% confidence interval [95% CI], 1.39-11.49; p = .010). In patients with hs-CRP elevation and highest-quartile I-FABP, sCD14 elevation (≥0.65 µg/mL, ie, the median) was associated with an 11-fold higher HAI risk (OR, 10.8; 95% CI, 2.28-51.1; p = .003). Multivariate analyses adjusted for invasive procedures and comorbidities did not change the associations linking the three markers to the HAI risk.Conclusion: Increased levels of hs-CRP, I-FABP, and sCD14 may reflect loss of intestinal epithelial barrier integrity with microbial translocation leading to monocyte activation and low-grade inflammation. In our cohort, these markers identified patients at high risk for HAIs

Automatic versus manual changeovers of norepinephrine infusion pumps in critically ill adults: a prospective controlled study

International audienceBackground: Norepinephrine is a key drug for treating shock but has a short half-life that requires continuous intravenous administration to maintain the constant plasma concentration needed to obtain a stable blood pressure. The small volume of the syringes used in power infusion pumps requires frequent changeovers, which can lead to norepinephrine flow interruptions responsible for hemodynamic instability. Changeovers from the nearly empty to the full syringe can be performed manually using the quick change technique (QC) or automatically using smart infusion pumps (SIP) that link two syringes. The purpose of our study was to evaluate the hypothesis that, compared to QC, SIP for norepinephrine changeovers was associated with less hemodynamic instability.Methods: After information of the patient or next of kin, patients receiving norepinephrine for shock were allocated to QC or SIP changeovers. QC changeovers were performed by a nurse, who started a new loaded pump when the previous syringe was nearly empty. SIP changeovers were managed automatically by SIP workstations. The primary outcome was the proportion of changeovers followed by a ≥20 % drop in mean arterial pressure (MAP).Results: 411 changeovers were performed, 193 in the 18 patients allocated to QC and 218 in the 32 patients allocated to SIP. Baseline patient characteristics were similar in both groups. The proportion of changeovers followed by an MAP drop ≥20 % was 12.4 % (24/193) with QC and 5.5 % (12/218) with SIP (P = 0.01). By multivariate analysis, two factors were independently associated with a significantly decreased risk of ≥20 % MAP drops during changeovers, namely, SIP (odds ratio, 0.47; 95 % confidence interval, 0.22–0.98) and norepinephrine dosage >0.5 μg/kg/min (odds ratio, 0.39; 95 % confidence interval, 0.19–0.81).Conclusions: The risk of MAP drops ≥20 % during changeovers can be significantly diminished using SIPs instead of the QC method

Efficacy of HE4, CA125, risk of malignancy index and risk of ovarian malignancy index to detect ovarian cancer in women with presumed benign ovarian tumours: a prospective, multicentre trial

Presumed benign ovarian tumours (PBOT) are defined by the International Ovarian Tumour Analysis (IOTA) group, without suspected sonographic criteria of cancer, without ascites or metastasis. The aim is to evaluate the efficacy of human epididymis protein 4 (HE4), cancer antigen 125 (CA125), the risk of malignancy index (RMI) and the risk of ovarian malignancy index (ROMA) to predict ovarian cancer in women with PBOT. Methods: It is a prospective, observational, multicentre, laboratory-based study including women with PBOT in four hospitals from 11 May 2015 through 12 May 2016. Preoperative CA125 and HE4 plasma levels were measured for all women. The primary endpoint was the specificity of CA125 and HE4 for diagnosing ovarian cancer. The main secondary endpoints were specificity and likelihood ratio of RMI, ROMA and tumours markers. Results: Two hundred and fifty patients were initially enrolled and 221 patients were finally analysed, including 209 benign ovarian tumours (94.6%) and 12 malignant ovarian tumours (5.4%). The malignant group had significantly higher mean values of HE4, CA125, RMI and ROMA compared to the benign group (p < 0.001). Specificity was significantly higher using a combination of HE4 and CA125 (99.5%) compared to either HE4 or CA125 alone (90.4% and 91.4%, respectively, p < 0.001). Moreover, the positive likelihood ratio for combination HE4 and CA125 was significantly higher (104.5; 95% CI 13.6–800.0) compared to HE4 alone (5.81; 95% CI 2.83–11.90) or CA125 alone (6.97; 95% CI 3.91–12.41). Conclusions: The combination of HE4 and CA125 represents the best tool to predict the risk of ovarian cancer in patients with a PBO

A comparative study of three-dimensional cone-beam CT sialography and MR sialography for the detection of non-tumorous salivary pathologies

International audienceBackground Imaging of the salivary ductal system is relevant prior to an endoscopic or a surgical procedure. Various imaging modalities can be used for this purpose. The aim of this study was to compare the diagnostic capability of three-dimensional (3D)-cone-beam computed tomography (CBCT) sialography versus magnetic resonance (MR) sialography in non-tumorous salivary pathologies.Methods: This prospective, monocenter, pilot study compared both imaging modalities in 46 patients (mean age 50.1 ± 14.9 years) referred for salivary symptoms. The analyses were performed by two independent radiologists and referred to identification of a salivary disease including sialolithiasis, stenosis, or dilatation (primary endpoint). The location and size of an abnormality, the last branch of division of the salivary duct that can be visualized, potential complications, and exposure parameters were also collected (secondary endpoints).Results Salivary symptoms involved both the submandibular (60.9%) and parotid (39.1%) glands. Sialolithiasis, dilatations, and stenosis were observed in 24, 25, and 9 patients, respectively, with no statistical differences observed between the two imaging modalities in terms of lesion identification (p 1 = 0.66, p 2 = 0.63, and p 3 = 0.24, respectively). The inter-observer agreement was perfect (> 0.90) for lesion identification. MR sialography outperformed 3D-CBCT sialography for visualization of salivary stones and dilatations, as evidenced by higher positive percent agreement (sensitivity) of 0.90 [95% CI 0.70–0.98] vs. 0.82 [95% CI 0.61–0.93], and 0.84 [95% CI 0.62–0.94] vs. 0.70 [95% CI 0.49–0.84], respectively. For the identification of stenosis, the same low positive percent agreement was obtained with both procedures (0.20 [95% CI 0.01–0.62]). There was a good concordance for the location of a stone (Kappa coefficient of 0.62). Catheterization failure was observed in two patients by 3D-CBCT sialography.Conclusions: Both imaging procedures warrant being part of the diagnostic arsenal of non-tumorous salivary pathologies. However, MR sialography may be more effective than 3D-CBCT sialography for the identification of sialolithiasis and ductal dilatations. Trial registration NCT02883140