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Impact of tracheal extubation location after surgical procedures on peri‐operative times: a prospective dual‐centre observational study*
No full textInternational audienceSummary Introduction Extubation of the trachea in the operating theatre may increase the time spent there. Conversely, tracheal extubation in the post‐anaesthesia care unit may prolong the duration of anaesthesia and increase the incidence of complications. Our primary objective was to quantify the additional occupancy time associated with tracheal extubation in the operating theatre compared with the post‐anaesthesia care unit. Secondary objectives were to assess the incidence of complications after tracheal extubation, including the need for ventilatory support. Methods This was a prospective dual‐centre observational cohort study of patients whose tracheas were intubated for surgery in the operating theatre of two university hospitals. The primary endpoint was operating theatre occupancy time between the end of surgical procedure and discharge from the operating theatre. Results In total, 756 patients were included, and 494 (65.3%) tracheal extubations occurred in the operating theatre. Room occupancy time was increased by 7 min (95%CI 5–8 min, p = 0.001) when tracheal extubation was performed in the operating theatre compared with the post‐anaesthesia care unit. After adjustment by matched or weighted propensity score, this time increased to 8 min (95%CI 6–10 min, p = 0.001) and 8 min (95%CI 6–9 min, p = 0.001), respectively. Desaturation after tracheal extubation (20.9% vs. 36.3%, p < 0.001) and arterial hypotension (0.6% vs. 3.1%, p = 0.019) were less frequent when tracheal extubation took place in the operating theatre. Discussion Tracheal extubation in the operating theatre is associated with an increase in theatre occupancy of < 8 min and a lower incidence of postoperative respiratory and cardiovascular complications
Intrapartum and childbirth care and outcomes in midwife-led birth centres in France: A nationwide descriptive study with an analysis of maternal and neonatal transfers
No full textInternational audienceProblem: Midwife-led birth centres (MLBCs) offer an alternative to obstetric-led units (OUs) for low-risk women. Despite positive assessments, their development still remains controversial. Aim: To assess the appropriateness of care, intrapartum and childbirth care, and outcomes of women with a planned birth in MLBCs and to describe transfers to OUs and their risk factors. Methods: This was a 2-year (2018-2019) nationwide population-based retrospective cohort involving women with a planned birth in all eight French MLBCs. We described the appropriateness of care, intrapartum and childbirth care, maternal and neonatal outcomes and causes of transfers to OUs. We calculated adjusted odds ratios to identify risk factors for transfers during labour and after birth. Results: Among 1313 women with a planned MLBC birth, the appropriateness of care was high, with 99.3 % of women meeting low-risk criteria. Intrapartum care in MLBCs featured few interventions (2.2 % artificial membrane ruptures and 1.1 % episiotomies). Regardless of the final place of birth, there were 90.8 % spontaneous vaginal births, 2.6 % caesarean births, 6.6 % operative vaginal births, 2.4 % severe postpartum haemorrhages, 0.4 % Apgar scores < 7 at 5 min and one neonatal death. Transfers to an OU involved 21 % of women with a planned birth in an MLBC during labour and 5.8 % after birth, mainly due to postpartum haemorrhage; 4.6 % of newborns were transferred, often for monitoring. Conclusion: With appropriate selection of women and low-intervention care, French MLBCs achieve salutogenic outcomes. We identified risk factors for transfers. Further research is needed to assess safety comprehensively with comparative studies
Clinical Benefits of Parasternal Block with Multihole Catheters when Inserted before Sternotomy
No full textInternational audienceABSTRACT Background: The aim of this study was to assess whether parasternal block with multihole catheters inserted before surgical incision enables to alleviate postoperative analgesia and opioid reduction in cardiac surgery patients with sternotomy. Methods: Twenty-six adult patients scheduled for cardiac surgery with sternotomy aged between 18 and 84 olds were included in this prospective, monocentric, open, single-group trial. Two parasternal multihole catheters were inserted on each side of the sternum before the surgical skin incision for cardiac surgery and 10 mL of ropivacaine 7.5 mg mL –1 was initially administered in each catheter. Local anesthetic administration followed by continued infusion at 3 mL hr –1 of ropivacaine 2 mg mL –1 per catheter for 48 h postoperatively upon patient arrival in the intensive care unit. The efficacy of the parasternal block was assessed according to a composite endpoint including pain score at rest, pain score during movements (dynamic pain), and morphine consumption over 48 hours. Results: The treatment failed in 11 patients and was considered effective in 15 patients. Sixteen patients out of 26 had a sternal pain score ≤≤3/10 on more than 75% of observations, and the treatment was considered successful. In 23/26 patients (88%), the mean pain score at cough was ≤≤3.5/10 and the treatment was considered successful. Morphine consumption over 48 h was significantly lower in the intervention group compared to the control group 7 mg [6; 21] versus 142 mg [116; 176] ( P < 0.001). Conclusions: Parasternal block with multihole catheters inserted before the surgical incision is an effective technique for postoperative analgesia and opioid reduction
OP38 Comparative efficacy of infliximab and vedolizumab after failure of a first anti-TNF in patients with ulcerative colitis: a double-blind randomized controlled trial (EFFICACI)
No full textInternational audienceBackground No clinical trial has previously assessed the best therapeutic strategy between switching to another anti-TNF or swapping to another class of biologic class after the failure of a first anti-TNF in ulcerative colitis (UC). The aim of the EFFICACI trial was to compare the efficacy of vedolizumab with infliximab in patients who had failed a first sub-cutaneous anti-TNF (golimumab and/or adalimumab). Methods EFFICACI was a French double-blind multicenter randomized controlled trial (1:1) comparing intravenous vedolizumab 300 mg at weeks 0-2-6 to intravenous infliximab 5 mg/kg at weeks 0-2-6. Eligible patients had moderate-to-severe UC, defined by a total Mayo score ≥ 6, despite at least 12 weeks (W) of treatment with adalimumab or golimumab as first line of advanced therapy. The primary endpoint was steroid free clinical remission at W14. The number of patients (N=150) was estimated for a 20% difference in favor of vedolizumab with a type 1 risk of 5% and a power of 80%. Patients were subsequently followed in an open-label fashion until week 54. The analysis was performed on an intention-to-treat basis. Only results at W14 will be presented. (CPP: 2018-002673-21; ClinicalTrial: 35RC17_8841_EFFICACI) Results From January 2018 to December 2023, 151 patients were randomized among 19 centers: 78 in the vedolizumab arm and 73 in the infliximab arm. Characteristics and demographics at inclusion were similar between groups, with 102/151 (67.5%) patients failing adalimumab and 49/151 (32.5%) failing golimumab. Concomitant immunosuppressive treatment with thiopurine or methotrexate was associated with infliximab and vedolizumab for 37/72 (51.4%) patients and 43/78 (55.1%) patients, respectively. At W14, proportions of patients in clinical remission (primary endpoint) were 34.6% (27/78) with vedolizumab and 19.2% (14/73) with infliximab (p=0.033). The clinical response rates were 46/78 (59.0%) with vedolizumab and 36/72 (50.0%) with infliximab (p=0.27). Proportions of patients in clinical response at W2, W6 and W14 are shown in Figure 1. At W14, endoscopic improvement (Mayo endoscopic subscore 0 or 1) was observed in 36/77 (46.8%) patients in the vedolizumab arm and 21/72 (29.2%) in the infliximab arm (p=0.027). No factor at inclusion was predictive of remission at week 14, including pharmacokinetic data for the first-line anti-TNF. Adverse event rates were similar in both groups - 46 (63.9%) infliximab arm, 55/78 (70.51%) vedolizumab arm. Eight patients were hospitalized for a severe flare (5 in the infliximab arm and 3 in the vedolizumab arm). Conclusion After failure of a first subcutaneous anti-TNF, induction therapy with vedolizumab was superior to infliximab in achieving steroid free clinical remission at week 14 in patients with UC
Evolution of the methodological requirements for surgery-related publications
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Analgesic efficacy of non-invasive neuromodulation techniques in chronic cancer pain: a systematic review
No full textInternational audiencePurpose: Chronic pain remains one of the most frequent and disabling symptoms of cancer, arising from tumors and/or treatments, and is poorly controlled in 40% of patients. Noninvasive brain stimulation (NIBS) is now widely recommended in drug-refractory neuropathic pain, but its effectiveness in chronic cancer-related pain remains unknown. A few observational studies and randomized controlled trials (RCTs) have assessed the effectiveness of NIBS on pain in this population.Methods: A systematic review of neuromodulation studies on patients with chronic cancerrelated pain involving transcranial direct currents stimulation (tDCS) or repetitive transcranial magnetic stimulation (rTMS) was conducted to estimate the analgesic efficacy, safety and feasibility in clinical routine.Results: Eleven publications (N=298 patients) were included and analyzed. For tDCS, three RCT had a moderate effect size of 0.7 [0.6; 0.9] on a rating scale (0-10), and two case reports showed a significant decrease of pain intensity on average by -4.25 ± 0.36 points. The rTMS provided similar pain relief, with two RCTs showing a large effect size of 0.9 [0.7; 1.1], two observational study studies reporting a significant pooled effect on pain intensity (-0.9 [-1.6; -0.1] and -2.3 [-3.3; -1.3]), and two case reports where pain was reduced on average by -4.75 ± 0.36 points. None of these studies reported serious adverse events, and discontinuations of treatment were associated with cancer complications.Conclusions: NIBS appears to have an analgesic effect in cancer-related pain. However, due to the high heterogeneity of pain conditions, placebo-controlled trials with larger and homogeneous patient cohorts are required to confirm these promising results.</div
Leveraging Deep Learning for Immune Cell Quantification and Prognostic Evaluation in Radiotherapy-Treated Oropharyngeal Squamous Cell Carcinomas.
No full textInternational audienceThe tumor microenvironment (TME) plays a critical role in cancer progression and therapeutic responsiveness, with the tumor immune microenvironment (TIME) being a key modulator. In head and neck squamous cell carcinomas (HNSCC), immune cell infiltration significantly influences the response to radiotherapy (RT). A better understanding of the TIME in HNSCC could help identify patients most likely to benefit from combining RT with immunotherapy. Standardized, cost-effective methods for studying TIME in HNSCC are currently lacking. This study aims to leverage deep learning (DL) to quantify immune cell densities using immunohistochemistry (IHC) in untreated oropharyngeal squamous cell carcinoma (OPSCC) biopsies of patients scheduled for curative RT, and to assess their prognostic value. We analyzed 84 pre-treatment formalin-fixed paraffin-embedded (FFPE) tumor biopsies from OPSCC patients. Immunohistochemistry was performed for CD3, CD8, CD20, CD163, and FOXP3, and whole slide images (WSIs) were digitized for analysis using a U-Net-based DL model. Two quantification approaches were applied: a cell-counting method and an area-based method. These methods were applied to stained regions. The DL model achieved high accuracy in detecting stained cells across all biomarkers. Strong correlations were found between our DL pipeline, the HALO® Image Analysis Platform, and the open-source QuPath software for estimating immune cell densities. Our DL pipeline provided an accurate and reproducible approach for quantifying immune cells in OPSCC. The area-based method demonstrated superior prognostic value for recurrence-free survival (RFS), when compared to the cell-counting method. Elevated densities of CD3, CD8, CD20, and FOXP3 were associated with improved RFS, while CD163 showed no significant prognostic association. These results highlight the potential of DL in digital pathology for assessing TIME and predicting patient outcomes. Further validation in larger cohorts is recommended
Pre-cachectic changes in amino acid homeostasis precede activation of eIF2α signaling in the liver at the onset of C26 cancer-induced cachexia
No full textInternational audienceThe sequence of events associated with cancer cachexia induction needs to be further characterized. Using the C26 mouse model, we found that prior to cachexia, cancer progression was associated with increased levels of IL-6 and growth differentiation factor 15 (GDF15), highly induced production of positive acute phase proteins (APPs) and reduced levels of most amino acids in the systemic circulation, while signal transducer and activator of transcription 3 (STAT3) signaling was induced (1) in the growing spleen, alongside activation of ribosomal protein S6 (rpS6) and alpha subunit of eukaryotic translation initiation factor-2 (eIF2α) signalings, and (2) in the liver, alongside increased positive-APP expression, decreased albumin expression, and upregulation of autophagy. At the onset of cachexia, rpS6 and eIF2α signalings were concomitantly activated in the liver, with increased expression of activating transcription factor 4 (ATF4) target genes involved in amino acid synthesis and transport, as well as autophagy. Data show that pre-cachectic (pre-Cx) alterations in protein/aa homeostasis are followed by activation of eIF2α signaling in the liver, an adaptive mechanism likely regulating protein/amino acid metabolism upon progression to cachexia
Personalised analgesia/nociception index-guided opioid administration for abdominal surgery
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Risk of Congenital Ocular Anomaly After Prenatal Exposure to Medications: A EUROmediCAT Study
No full textInternational audienceBackground: In Europe, the prevalence of congenital ocular anomaly (COA) is estimated at 3.7 per 10,000 births. While certain COAs have a genetic origin, the cause for most patients remains unknown. The role of medications administered during pregnancy in COA genesis in humans is unclear.Objective: To investigate any association between fetal exposure in the first trimester of pregnancy to medications and the occurrence of COA.Methods: We conducted a case-malformed-control study using data on 298,351 cases registered as having congenital anomalies (CA) from 19 registries and one healthcare database in 13 European countries. Two analyses were performed: (i) A signal confirmation analysis of signals from the literature, examining associations between COA and specific medications (nitrofurantoin, NSAIDs, opioids, alprazolam, antihypertensives, asthma medications, pyridoxine, and hydroxyethylrutoside). (ii) A signal detection analysis of all medications reported in the database.Results: We identified 4185 COA cases and 232,718 nongenetic and 38,409 genetic controls. We confirmed the association between prenatal opioid exposure and COA (aROR: 2.66, 95% CI: 1.18, 6.02, and 3.22, 95% CI: 1.35, 7.69, for nongenetic and genetic controls, respectively). Signal detection analysis revealed consistent associations for antiglaucoma preparations and miotics (p < 0.01) related to COA. Other associations included congenital cataracts and lens anomalies with desloratadine, congenital glaucoma with antiepileptics, and eyelid malformations with dermatological hydrocortisone.Conclusions: This pharmacoepidemiological study in Europe analyzing COA following fetal medication exposure confirmed reported signals regarding opioids and COA and identified new associations. Validation in independent datasets is necessary to consolidate these findings