Albumin Versus Balanced Crystalloid for the Early Resuscitation of Sepsis: An Open Parallel-Group Randomized Feasibility Trial. The ABC-Sepsis Trial.

OBJECTIVES: International guidelines recommend IV crystalloid as the primary fluid for sepsis resuscitation, with 5% human albumin solution (HAS) as the second line. However, it is unclear which fluid has superior clinical effectiveness. We conducted a trial to assess the feasibility of delivering a randomized controlled trial comparing balanced crystalloid against 5% HAS as sole early resuscitation fluid in patients with sepsis presenting to hospital. DESIGN: Multicenter, open, parallel-group randomized feasibility trial. SETTING: Emergency departments (EDs) in 15 U.K. National Health Service (NHS) hospitals. PATIENTS: Adult patients with sepsis and a National Early Warning Score 2 greater than or equal to five requiring IV fluids withing one hour of randomization. INTERVENTIONS: IV fluid resuscitation with balanced crystalloid or 5% HAS for the first 6 hours following randomization. MEASUREMENTS AND MAIN RESULTS: Primary feasibility outcomes were recruitment rate and 30-day mortality. We successfully recruited 301 participants over 12 months. Mean (sd) age was 69 years (± 16 yr), and 151 (50%) were male. From 1303 participants screened; 502 participants were potentially eligible and 300 randomized to receive trial intervention with greater than 95% of participants receiving the intervention. The median number of participants per site was 19 (range, 1-63). Thirty-day mortality was 17.9% (n = 53). Thirty-one participants died (21.1%) within 30 days in the 5% HAS arm, compared with 22 participants (14.8%) in the crystalloid arm (adjusted odds ratio, 1.50; 95% CIs, 0.84-2.83). CONCLUSIONS: Our results suggest it is feasible to recruit critically ill patients to a fluid resuscitation trial in U.K. EDs using 5% HAS as a primary resuscitation fluid. There was lower mortality in the balanced crystalloid arm. Given these findings, a definitive trial is likely to be deliverable, but the point estimates suggest such a trial would be unlikely to demonstrate a significant benefit from using 5% HAS as a primary resuscitation fluid in sepsis.

From a voluntary vaccination policy to mandatory vaccination against COVID-19 in cancer patients: an empirical and interdisciplinary study in bioethics.

BACKGROUND: At the start of 2021, oncologists lacked the necessary scientific knowledge to adapt their clinical practices optimally when faced with cancer patients refusing or reluctant to be vaccinated against COVID-19, despite the marked vulnerability of these patients to severe, and even fatal forms of this new viral infectious disease. Oncologists at Foch Hospital were confronted with this phenomenon, which was observed worldwide, in both the general population and the population of cancer patients. METHODS: Between April and November 2021, the Ethics and Oncology Departments of Foch Hospital decided to investigate this subject, through an empirical and interdisciplinary study in bioethics. Our scientific objective was to try to identify and resolve the principal bio-ethical issues, with a view to improving clinical practices in oncology during future major pandemics of this kind, from a highly specific bio-ethical standpoint (= quality of life/survival). We used a mainly qualitative methodological approach based on questionnaires and interviews. RESULTS: In April 2021, 29 cancer patients refused or were reluctant to be vaccinated (5.6%; 29/522). Seventeen of these patients said that making vaccination mandatory would have helped them to accept vaccination. In October 2021, only 10 cancer patients continued to maintain their refusal (1.9%; 10/522). One of the main reasons for the decrease in refusals was probably the introduction of the "pass sanitaire" (health pass) in July 2021, which rendered vaccination indispensable for many activities. However, even this was not sufficient to convince these 10 cancer patients. CONCLUSION: We identified a key bio-ethical issue, which we then tried to resolve: vaccination policy. We characterized a major tension between "the recommendation of anti-COVID-19 vaccination" (a new clinical practice) and "free will" (a moral value), and the duty to "protect each other" (a moral standard). Mandatory vaccination, at least in France, could resolve this tension, with positive effects on quality of life (i.e. happiness), or survival, in cancer patients initially refusing or reluctant to be vaccinated, but only if collective and individual scales are clearly distinguished.

Back to the future: vaginal hysterectomy and Campbell uterosacral ligaments suspension for urogenital prolapse.

INTRODUCTION AND HYPOTHESIS: To evaluate vaginal hysterectomy (VH) associated with vaginal native tissue repair (VNTR) using Campbell uterosacral ligament suspension (C-USLS) for the treatment of predominant uterine prolapse associated with cystocele. METHODS: We conducted a retrospective monocentric study including patients who underwent VH and C-USLS, without concomitant mesh, for primary urogenital prolapse between January 2011 and June 2018. We evaluated the anterior and apical prolapse recurrence rate, using a composite criterion (symptomatic, asymptomatic recurrence, POP-Q stage ≥ 2). We analyzed 2-year recurrence-free survival using the Kaplan-Meier method. Univariate and multivariate analyses were performed to identify variables associated with recurrence. Secondary outcomes included postoperative complications, lower urinary tract symptoms (LUTS) and sexual satisfaction. RESULTS: Ninety-four patients were included. Eighty-three (88.3%) and 65 (69.1%) patients had stage ≥ 3 uterine prolapse and cystocele, respectively. Mean follow-up was 36 months. Prolapse recurrence rate was 21.3% including 3.2% of cystocele. Two-year recurrence-free survival was 80%. Age, body mass index, POP-Q stage and associated surgical procedure were not significantly associated with recurrence. Early complications were reported for 20 patients (21.2%), mostly grade ≤ 2 (95%). De novo LUTS were reported in 11 cases (11.7%). Preoperative stress urinary incontinence and urgency were cured for 12 (80%) and 29 (80.6%) patients, respectively. Sexual satisfaction rate for patients with preoperative sexual activity was 95.8%. CONCLUSION: C-USLS following VH as primary treatment for predominant uterine prolapse with associated cystocele is a safe procedure with satisfying mid-term functional results. This VNTR could be an alternative in light of the worldwide market withdrawal of actual vaginal mesh.

Comprehensive assessment of postoperative mobility during the first days after mini-invasive lung surgery: A prospective observational study.

STUDY OBJECTIVE: Postoperative physical therapy and early mobilization are major elements for enhanced recovery after surgery. In contrast with supervised physical therapy sessions that can be monitored, self-mobilization is not easily quantifiable and has so far been estimated mainly through patient auto-reports. This study aimed to perform a comprehensive and objective evaluation of postoperative mobility. DESIGN: Prospective observational study. SETTING: Postoperative setting. PATIENTS: Patients undergoing mini-invasive lung surgery. INTERVENTIONS: Measurement of postoperative mobility during the first five postoperative days using an accelerometer (ActiGraph GT3X). MEASUREMENTS: The primary outcome was the number of daily steps. Secondary outcomes included physical activity duration and intensity, sedentary time, number of breaks in sedentary time, sedentary patterns, daily evaluation by physiotherapists, postoperative complications, and acceptability of wearing the accelerometer. MAIN RESULTS: Sixty patients were included in the study, of whom 56 provided at least one day of valid accelerometry data. There was no significant change during the first four PODs concerning the number of daily steps nor the mean cadence. One-minute cadence peak, total activity counts, and duration of light-intensity physical activity increased over time (p = 0.032, p = 0.001 and p = 0.001, respectively). Sedentary patterns changed favorably over time, with a decrease in prolonged sedentary bouts (≥ 60 consecutive min) (p < 0.001), and an increase in shorter bouts (< 10 min) (p = 0.001). Similar results were observed when analysis was adjusted for the day of the week when the surgery took place. The median acceptability of wearing the accelerometer was excellent (median 10 [9-10] on a 10-point Likert scale). Three patients had major complications. CONCLUSIONS: Our findings suggest that daily steps may not be the only relevant indicator of early mobility following thoracic surgery and that accelerometry is suitable to follow patients' early postoperative activity.

Prospective Radiologic-Pathologic Correlation of Macroscopic Volume and Microscopic Extension of Nonsolid Lung Nodules on Thin-section CT Images for Sublobar Resection and Stereotactic Radiotherapy Planning.

INTRODUCTION: The objective of this study was to determine whether computed tomography (CT) could be a useful tool for nonsolid lung nodule (NSN) treatment planning, surgery or stereotactic body radiation therapy (SBRT), by assessing the macroscopic and microscopic extension of these nodules. METHODS: The study prospectively included 23 patients undergoing anatomic resection at the Foch Hospital in 2020/2021 for NSN with a ground-glass component of more than 50%. Firstly, for each patient, both the macroscopic dimensions of the NSN were assessed on CT and during pathologic analysis. Secondly, the microscopic extension was assessed during pathologic examination. Wilcoxon sign rank tests were used to compare these dimensions. Spearman correlation test and Bland-Altman analysis were used to evaluate the agreement between radiological and pathologic measurements. RESULTS: On CT, the median largest diameter and volume of NSN were 21 mm and 3780 cc, while on pathologic analysis, they were 15 mm and 1800 cc, respectively. Therefore, the largest diameter and volume of the NSN were significantly higher on CT than on pathological analysis. For microscopic extension, the median largest diameter and volume of NSN were 17 mm and 2040 cc, respectively. No significant difference was observed between the macroscopic size and the microscopic extension assessed during pathologic analysis. Moreover, correlation analysis and Bland-Altman plots showed that radiological and pathologic measurements could provide equivalent precision. CONCLUSION: Our study showed that CT did not underestimate the macroscopic size and microscopic extension of NSN and confirmed that CT can be used for NSN treatment planning.

Impact of COVID-19 on Subclinical Placental Thrombosis and Maternal Thrombotic Factors.

BACKGROUND: In the context of the SARS-CoV-2 pandemic, our interest was to evaluate the effect of COVID-19 during pregnancy on placenta and coagulation factors. METHODS: a prospective cohort study between January and July 2021 of 55 pregnant women stratified into: Group O, 16 patients with ongoing SARS-CoV-2 infection at delivery; Group R, 21 patients with a history of SARS-CoV-2 infection during pregnancy but who recovered prior to delivery; Group C, 18 control patients with no infection at any time. All women had nasopharyngeal SARS-CoV-2 RT-PCR tests performed within 72 h of delivery. Obstetrical complications were recorded and two physiological inhibitors of coagulation, protein Z (PZ) and dependent protease inhibitor (ZPI), were analyzed in maternal and cord blood. All placentae were analyzed by a pathologist for vascular malperfusion. RESULTS: No patient in any group had a severe COVID-19 infection. More obstetrical complications were observed in Group O (O: n = 6/16 (37%), R: n = 2/21 (10%), C: n = 1/18 (6%), p = 0.03). The incidence of placental vascular malperfusion was similar among the groups (O: n = 9/16 (56%), R: n = 8/21 (42%), C: n = 8/18 (44%), p = 0.68). No PZ or ZPI deficiency was associated with COVID-19. However, an increased ZPI/PZ ratio was observed in neonates of Group R (O: 82.6 (min 41.3-max 743.6), R: 120.7 (29.8-203.5), C: 66.8 (28.2-2043.5), p = 0.04). CONCLUSION: COVID-19 was associated with more obstetrical complications, but not an increased incidence of placental lesions or PZ and ZPI abnormalities.

Influence of videolaryngoscopy using McGrath Mac on the need for a helper to perform intubation during general anaesthesia: a multicentre randomised video-no-video trial.

OBJECTIVE: We hypothesised that videolaryngoscopy modifies practice of tracheal intubation. DESIGN: Randomised single-blinded study (video and no-video groups). SETTING: Three institutions: one academic, one non-profit and one profit. PARTICIPANTS: Patients >18 years, requiring orotracheal intubation, without predicted difficult intubation. Non-inclusion criterion was patients requiring a rapid-sequence intubation. 300 patients were included, 271 randomised, 256 analysed: 123 in the no-video and 133 in the video groups. INTERVENTION: Tracheal intubation using a McGrath Mac videolaryngoscope, the sequence being video recorded. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was the proportion of intubations where assistance is necessary on request of the operator. Secondary outcomes included intraoperative variables (intubation difficulty scale and its components, percentage of glottic opening score, oesophageal Intubation, duration of intubation, removal of the screen cover in the no-video group, global evaluation of the ease of intubation, bispectral index, heart rate and blood pressure), intraoperative and postoperative complications (hoarseness or sore throat) and cooperation of the anaesthesiology team. RESULTS: Requirement for assistance was not decreased in the Video group: 36.1% (95% CI 27.9 to 44.9) vs 45.5% (95% CI 36.5 to 54.7) in the no-video group, p=0.74; OR: 0.7 (95% CI 0.4 to 1.1) and absolute risk: 0.10 (95% CI -0.03 to 0.22). Intubation difficulty scale was similar in both groups (p=0.05). Percentage of glottic opening score was better in the Video group (median of 100 (95% CI (100 to 100) and 80 (95%CI (80 to 90) in the no-video group; p<0.001) as Cormack and Lehane grade (p=0001). Ease of intubation was considered better in the video group (p<0.001). Other secondary outcomes were similar between groups. Screen cover was removed in 7.3% (95% CI (2.7 to 11.9)) of the cases in the video group. No serious adverse event occurred. Communication and behaviour within the anaesthesia team were appropriate in all cases. CONCLUSION: In patients without predicted difficult intubation, videolaryngoscopy did not decrease the requirement for assistance to perform intubation. TRIAL REGISTRATION NUMBER: NCT02926144; Results.

Plasticity of natural killer cells in pregnant patients infected with SARS-CoV-2 and their neonates during childbirth.

The COVID-19 pandemic has occurred due to infection caused by the SARS-CoV-2 coronavirus, which impacts gestation and pregnancy. In SARS-CoV-2 infection, only very rare cases of vertical transmission have been reported, suggesting that fetal immune imprinting due to a maternal infection is probably a result of changes in maternal immunity. Natural killer (NK) cells are the leading maternal immune cells that act as a natural defense system to fight infections. They also play a pivotal role in the establishment and maintenance of pregnancy. While peripheral NK cells display specific features in patients infected with SARS-CoV-2 in the general population, information remains elusive in pregnant mothers and neonates. In the present study, we analyzed the characteristics of NK cells isolated from both neonatal umbilical cord blood and maternal peripheral blood close to the time of delivery. Phenotype and functions were compared in 18 healthy pregnant women and 34 COVID-19 patients during pregnancy within an ongoing infection (PCR+; N = 15) or after recovery (IgG+PCR-; N = 19). The frequency of NK cells from infected women and their neonates was correlated with the production of inflammatory cytokines in the serum. The expression of NKG2A and NKp30, as well as degranulation of NK cells in pregnant women with ongoing infection, were both negatively correlated to estradiol level. Furthermore, NK cells from the neonates born to infected women were significantly decreased and also correlated to estradiol level. This study highlights the relationship between NK cells, inflammation, and estradiol in patients with ongoing infection, providing new insights into the impact of maternal SARS-CoV-2 infection on the neonate.

Early Postoperative Pain Trajectories after Posterolateral and Axillary Approaches to Thoracic Surgery: A Prospective Monocentric Observational Study.

Less-invasive thoracotomies may reduce early postoperative pain. The aims of this study were to identify pain trajectories from postoperative days 0-5 after posterolateral and axillary thoracotomies and to identify potential factors related to the worst trajectory. Patients undergoing a posterolateral (92 patients) or axillary (89 patients) thoracotomy between July 2014 and November 2015 were analyzed in this prospective monocentric cohort study. The best-fitting model resulted in four pain trajectory groups: trajectory 1, the "worst", with 29.8% of the patients with permanent significant pain; trajectory 2 with patients with low pain (32.6%); trajectory 3 with patients with a steep decrease in pain (22.7%); and trajectory 4 with patients with a steep increase (14.9%). According to a multinomial logistic model multivariable analysis, some predictive factors allow for differentiation between trajectory groups 1 and 2. Risk factors for permanent pain are the existence of preoperative pain (OR = 6.94, CI 95% (1.54-31.27)) and scar length (OR = 1.20 (1.05-1.38)). In contrast, ASA class III is a protective factor in group 1 (OR = 0.02 (0.001-0.52)). In conclusion, early postoperative pain can be characterized by four trajectories and preoperative pain is a major factor for the worst trajectory of early postoperative pain.

Effects of a Single Application of ScenarTM, a Low-Frequency Modulated Electric Current Therapy, for Pain Relief in Patients with Low Back and Neck Pain: A Randomized Single Blinded Trial.

We aimed to demonstrate the antalgic effectiveness of ScenarTM (Self-Controlled Electro Neuro Adaptative Regulation) in patients experiencing low back and neck pain. Sixty patients were included and equally assigned by randomization to a Scenar-On group and to a Scenar-Off group (sham group). All patients received a 20 min application of ScenarTM on the area where they experienced pain. The pain at rest and during movement and the sensation of stiffness were assessed using a numeric rating scale at baseline, immediately after the session and 24 h after the session. The patients' characteristics at entry were similar between groups. The pain at rest decreased after the session in both groups (from 8 (4) to 5.0 (3) in the Scenar-Off group, p = 0.0001, and from 7 (3) to 4 (4) in the Scenar-On group, p < 0.0001). The difference was not statistically significant for the groups (p = 0.22). Similar results were observed during movement, but the sensation of stiffness was not modified. Such beneficial results did not last until the next day. No undesirable major effects were noticed. Our study does not support the fact that one ScenarTM session improves low back and neck pain better than a sham session.

Risks factors FOR wound complications after cesarean section.

OBJECTIVE: The primary outcome was to determine risks factors for wound complications after cesarean section. Secondary outcome was the management of these complications. STUDY DESIGN: We performed a retrospective cohort study of consecutive cesarean deliveries performed at a secondary care facility between June 2017 and June 2019. Composite wound complications included infection, disruption and fluid collection occurring 30 days post-operatively. Medical records were reviewed and data including patient demographics, comorbidities, intra-partum characteristics were evaluated as potential risk factors for wound complications using multivariate logistic regression. Secondarily, post-operative management of wound complications was described. RESULTS: Among 1520 patients undergoing cesarean section during the period of study, 67 developed wound complications (4.4 %). Mean Duration of local wound care was 41.35 days (2-95). Mean number of wound care related visits in our hospital was 4.85(1-11). Multivariate logistic regression analysis showed 2 significant independant risk factors: preeclampsia with OR 5.60, 95 % CI 2.83, 11.11 (p:<0.001), and premature rupture of the membranes with OR 9.76, 95 % CI 2.13, 44.77 (p: 0.003). CONCLUSION: Preeclampsia and premature rupture of the membrane were independent risk factors for wound complications after cesarean section. Information regarding higher rates of wound complications and preventive measures should be provided to high-risk women prior to surgery.

Prehabilitation Program in Elderly Patients: A Prospective Cohort Study of Patients Followed Up Postoperatively for Up to 6 Months.

The preoperative period may be an opportune period to optimize patients' physical condition with a multimodal preoperative program. The impact of a "prehabilitation" program on elderly patients is discussed. This mono-center observational cohort study included consecutively 139 patients planned for major abdominal and thoracic surgery, with 44 in the control group (age < 65) and 95 in the elderly group (age > 65). All patients followed a "prehabilitation" program including exercise training, nutritional optimization, psychological support, and behavioral change. Seventeen patients in the control group and 45 in the elderly group completed the study at six months. The 6-minute walk test (6 MWT) increased in both groups from the initial evaluation to the last (median value of 80 m (interquartile range 51) for those under 65 years; 59 m (34) for the elderly group; p = 0.114). The 6 MWT was also similar after one month of prehabilitation for both populations. The rate of postoperative complications was similar in the two groups. Prehabilitation showed equivalence in patients over 65 years of age compared to younger patients in terms of increase in functional capabilities and of postoperative evolution. This multimodal program represents a bundle of care that can benefit a frailer population.

Robotic Hysterectomy for Benign Indications: What Have We Learned from a Decade?

BACKGROUND AND OBJECTIVES: Robotic surgery data need a setback on many years of practice with high-volume surgeons to evaluate its real value. Our main objective was to study the impact of a decade of robotic surgery on minimally-invasive hysterectomies for benign indications. Our secondary objectives were to evaluate our results for high-volume surgeons and complex cases. METHODS: In this retrospective cohort study, we reviewed medical records at Foch Hospital, from 2010 to 2019, to evaluate the outcomes of robotic hysterectomies for benign disease. We compared the trends of benign hysterectomies done by laparoscopy and laparotomy during this period. We analyzed the proficiency group (≥ 75 cases per surgeon) and complex cases including obese patients and large uteri (>250 g). RESULTS: 495 hysterectomies were performed by robotic, 275 by laparotomy, and 130 by laparoscopy. The laparotomy approach decreased from 62% to 29%, whereas the robotic approach increased from 26% to 61%. The operating room (OR) time decreased in the proficiency group (157.3 ± 43.32 versus 178.6 ± 48.05, P = 0.005); whereas the uterine weight was higher (194.6 ± 158.6 versus 161.3 ± 139.4, P = 0.04). Lower EBL and shorter OR time were seen with uteri ≤ 250 g subgroup (64.24 ± 110.2 ml versus 116.63 ± 146.98 ml, P = 0.0004) (169.62 ± 47.50 min versus 192.44 ± 45.82 min, P = 0.0001). The estimated blood loss (EBL) was less in the BMI ≤ 30 subgroup (68.83 ± 119.24 ml versus 124.53 ± 186.14 ml, P = 0.0005). CONCLUSION: A shift was observed between the laparotomy and robotic approaches. High-volume surgeons were more efficient and showed a decrease in OR time after 75 cases despite an increase in uterine weight.

Automated AI-Driven CT Quantification of Lung Disease Predicts Adverse Outcomes in Patients Hospitalized for COVID-19 Pneumonia.

The purpose of our work was to assess the independent and incremental value of AI-derived quantitative determination of lung lesions extent on initial CT scan for the prediction of clinical deterioration or death in patients hospitalized with COVID-19 pneumonia. 323 consecutive patients (mean age 65 ± 15 years, 192 men), with laboratory-confirmed COVID-19 and an abnormal chest CT scan, were admitted to the hospital between March and December 2020. The extent of consolidation and all lung opacities were quantified on an initial CT scan using a 3D automatic AI-based software. The outcome was known for all these patients. 85 (26.3%) patients died or experienced clinical deterioration, defined as intensive care unit admission. In multivariate regression based on clinical, biological and CT parameters, the extent of all opacities, and extent of consolidation were independent predictors of adverse outcomes, as were diabetes, heart disease, C-reactive protein, and neutrophils/lymphocytes ratio. The association of CT-derived measures with clinical and biological parameters significantly improved the risk prediction (p = 0.049). Automated quantification of lung disease at CT in COVID-19 pneumonia is useful to predict clinical deterioration or in-hospital death. Its combination with clinical and biological data improves risk prediction.