Association between prehospital shock index and mortality among patients with COVID-19 disease.

BACKGROUND: There exists a need for prognostic tools for the early identification of COVID-19 patients requiring intensive care unit (ICU) admission and mortality. Here we investigated the association between a clinical (initial prehospital shock index (SI)) and biological (initial prehospital lactatemia) tool and the ICU admission and 30-day mortality among COVID-19 patients cared for in the prehospital setting. METHODS: We retrospectively analysed COVID-19 patients initially cared for by a Paris Fire Brigade advanced (ALS) or basic life support (BLS) team in the prehospital setting between 2020, March 08th and 2020, May 30th. We assessed the association between prehospital SI and prehospital lactatemia and ICU admission and mortality using logistic regression model analysis after propensity score matching with Inverse Probability Treatment Weighting (IPTW) method. Covariates included in the IPTW propensity analysis were: age, sex, body mass index (BMI), initial respiratory rate (iRR), initial pulse oximetry without (SpO2i) and with oxygen supplementation (SpO2i.O2), initial Glasgow coma scale (GCSi) value, initial prehospital SI and initial prehospital lactatemia. RESULTS: We analysed 410 consecutive COVID-19 patients [254 males (62%); mean age, 64 ± 18 years]. Fifty-seven patients (14%) deceased on the scene, of whom 41 (72%) were male and were significantly older (71 ± 12 years vs. 64 ± 19 years; P 〈10-3). Fifty-three patients (15%) were admitted in ICU and 39 patients (11%) were deceased on day-30. The mean prehospital SI value was 1.5 ± 0.4 and the mean prehospital lactatemia was 2.0 ± 1.7 mmol.l-1. Multivariate logistic regression analysis on matched population after IPTW propensity analysis reported a significant association between ICU admission and age (adjusted Odd-Ratio (aOR), 0.90; 95% confidence interval (95%CI): 0.93-0.98;p = 10-3), SpO2i.O2 (aOR, 1.10; 95%CI: 1.02-1.20;p = 0.002) and BMI (aOR, 1.09; 95% CI: 1.03-1.16;p = 0.02). 30-day mortality was significantly associated with SpO2i.O2 (aOR, 0.92; 95% CI: 0.87-0.98;p = 0.01 P < 10-3) and GCSi (aOR, 0.90; 95% CI: 0.82-0.99;p = 0.04). Neither prehospital SI nor prehospital lactatemia were associated with ICU admission and 30-day mortality. CONCLUSION: Neither prehospital initial SI nor lactatemia were associated with ICU admission and 30-day mortality among COVID-19 patients initially cared for by a Paris Fire Brigade BLS or ALS team. Further prospective studies are needed to confirm these preliminary results.

Methods of induction of labor and women's experience: a population-based cohort study with mediation analyses.

BACKGROUND: Negative childbirth experience may affect mother wellbeing and health. However, it is rarely evaluated in studies comparing methods of induction of labor (IoL). AIM: To compare women's experience of IoL according to the method, considering the mediating role of interventions and complications of delivery. METHODS: We used data from the MEDIP prospective population-based cohort, including all women with IoL during one month in seven French perinatal networks. The experience of IoL, assessed at 2 months postpartum, was first compared between cervical ripening and oxytocin, and secondarily between different cervical ripening methods. Mediation analyses were used to measure the direct and indirect effects of cervical ripening on maternal experience, through delivery with interventions or complications. FINDINGS: The response rate was 47.8% (n = 1453/3042). Compared with oxytocin (n = 541), cervical ripening (n = 910) was associated less often with feelings that labor went 'as expected' (adjusted risk ratio for the direct effect 0.78, 95%CI [0.70-0.88]), length of labor was 'acceptable' (0.76[0.71-0.82]), 'vaginal discomfort' was absent (0.77[0.69-0.85]) and with lower global satisfaction (0.90[0.84-0.96]). Interventions and complications mediated between 6 and 35% of the total effect of cervical ripening on maternal experience. Compared to the dinoprostone insert, maternal experience was not significantly different with the other prostaglandins. The balloon catheter was associated with less pain. DISCUSSION: Cervical ripening was associated with a less positive experience of childbirth, whatever the method, only partly explained by interventions and complications of delivery. CONCLUSION: Counselling and support of women requiring cervical ripening might be enhanced to improve the experience of IoL.

Target populations to reduce cesarean rates after induced labor: A national population-based cohort study.

INTRODUCTION: Great variations in cesarean rates after induction of labor exist and reasons for these disparities remain unclear. They may be explained by individual characteristics or obstetric practices. Ten-group classification systems have proved their utility to monitor cesarean rates in general population. We aimed to identify groups of women that account for most cesareans after induction of labor using the Nippita reproducible 10-group classification, specifically designed for induced population. MATERIAL AND METHODS: A prospective population-based cohort study was performed in 94 French maternity units, including 3042 women undergoing induction of labor. Women were sorted according to 10 mutually exclusive groups based on parity, weeks of gestation, number of fetuses, fetal presentation and previous cesarean delivery. Relative size, cesarean delivery rate and contribution to the overall cesarean rate were described for each group. Cesarean rates were compared according to the Bishop score at the onset of labor induction. Indications for cesarean delivery were also described in the groups that contributed most to the overall cesarean rate. The MEDIP protocol was registered in ClinicalTrial (NCT02477085). RESULTS: The overall cesarean rate was 21.0% among this population of induced women. Nulliparous women with a term singleton cephalic fetus (groups 1, 2 and 3; at 37-38, 39-40 and ≥41 weeks of gestation, respectively) accounted for two-thirds of the overall cesarean rate because they were the largest group (relative size of 10.6, 16.6 and 18.1%, respectively) and had higher cesarean rates (27.2, 30.9 and 33.0%, respectively). When the Bishop score was <6 (n = 2270/3042), cesarean delivery rates were higher (24.1 vs 10.7% if Bishop score ≥6, P < 0.01), in particular for group 1 (29.1 vs 12.5%, P = 0.02), and group 2 (33.3 vs 19.3%, P = 0.01). In groups 1, 2 and 3, which contributed most to the overall cesarean rate, a significant part of the cesareans were performed before 6 cm of cervical dilation for dystocia only (40.0, 16.7 and 17.6%, respectively). CONCLUSIONS: Nulliparous women with a term singleton cephalic fetus and an unfavorable cervix represent the population to target for auditing induction practices. Specific actions could be implemented among this population to weigh the benefits and risks of induction and improve the management of labor induction.

Comparison of effectiveness and safety of cervical ripening methods for induction of labour: A population-based study using coarsened exact matching.

BACKGROUND: There is no consensus about the ideal cervical ripening method to use for induction of labour. OBJECTIVE: To compare in current practice the effectiveness and safety of four cervical ripening methods. METHODS: We performed a matched comparative study using data from the MEDIP prospective population-based cohort conducted during one month in 2015 in all maternity units of seven French perinatal networks (3042 consecutive women with a live fetus and induction of labour). We analysed 1671 women with singleton cephalic fetus, unscarred uterus, and bishop score <7. Dinoprostone vaginal pessary (reference) was compared to dinoprostone vaginal gel, misoprostol vaginal tablet, and balloon catheter. Effectiveness outcomes were the need for more than one induction agent, oxytocin use, failure to achieve vaginal delivery within 24 hours (VD < 24 hours), and caesarean delivery. Safety outcomes were meconium-stained amniotic fluid, uterine hyperstimulation, NICU admission, and post-partum haemorrhage. Coarsened exact matching was used to balance confounders among the groups. Outcomes were compared using multivariable logistic regression models. RESULTS: Compared to the dinoprostone pessary (N = 1142, 68.3%), dinoprostone gel (N = 335, 20.1%) was associated with less failure to achieve VD < 24 hours (adjusted OR 0.66, 95% CI 0.47, 0.91). Misoprostol (N = 103, 6.2%) was associated with less need of more than one induction agent (aOR 0.56, 95% CI 0.34, 0.92) and less oxytocin use (aOR 0.60, 95% CI 0.37, 0.99). The balloon catheter (N = 91, 5.4%) was associated with more failure to achieve VD < 24 hours (aOR 2.62, 95% CI 1.37, 5.01), more caesarean delivery (aOR 1.84, 95% CI 1.09, 3.08), and less meconium-stained amniotic fluid (aOR 0.12, 95% CI 0.02, 0.70). Uterine hyperstimulation rates seemed lower with the balloon catheter (1.2% vs 4.2% for the pessary). CONCLUSIONS: In current practice, no cervical ripening method appears clearly superior to the others considering all effectiveness and safety outcomes.

Analysis during chest compressions in out-of-hospital cardiac arrest patients, a cross/sectional study: The DEFI 2022 study.

AIMS: During out-of-hospital cardiac arrest (OHCA), an automatic external defibrillator (AED) analyzes the cardiac rhythm every two minutes; however, 80% of refibrillations occur within the first minute post-shock. We have implemented an algorithm for Analyzing cardiac rhythm While performing chest Compression (AWC). When AWC detects a shockable rhythm, it shortens the time between analyses to one minute. We investigated the effect of AWC on cardiopulmonary resuscitation quality. METHOD: In this cross-sectional study, we compared patients treated in 2022 with AWC, to a historical cohort from 2017. Inclusion criteria were OHCA patients with a shockable rhythm at the first analysis. Primary endpoint was the chest compression fraction (CCF). Secondary endpoints were cardiac rhythm evolution and survival, including survival analysis of non-prespecified subgroups. RESULTS: In 2017 and 2022, 355 and 377 OHCAs met the inclusion criteria, from which we analyzed the 285 first consecutive cases in each cohort. CCF increased in 2022 compared to 2017 (77% [72-80] vs 72% [67-76]; P < 0.001) and VF recurrences were shocked more promptly (53 s [32-69] vs 117 s [90-132]). Survival did not differ between 2017 and 2022 (adjusted hazard-ratio 0.96 [95% CI, 0.78-1.18]), but was higher in 2022 within the sub-group of OHCAs that occurred in a public place and within a short time from call to AED switch-on (adjusted hazard ratio 0.85[0.76-0.96]). CONCLUSIONS: OHCA patients treated with AWC had higher CCF, shorter time spent in ventricular fibrillation, but no survival difference, except for OHCA that occurred in public places with short intervention time.

Prehospital Lyophilized Plasma Transfusion for Trauma-Induced Coagulopathy in Patients at Risk for Hemorrhagic Shock: A Randomized Clinical Trial.

Importance: Blood transfusion is a mainstay of therapy for trauma-induced coagulopathy, but the optimal modalities for plasma transfusion in the prehospital setting remain to be defined. Objective: To determine whether lyophilized plasma transfusion can reduce the incidence of trauma-induced coagulopathy compared with standard care consisting of normal saline infusion. Design, Setting, and Participants: This randomized clinical trial was performed at multiple centers in France involving prehospital medical teams. Participants included 150 adults with trauma who were at risk for hemorrhagic shock and associated coagulopathy between April 1, 2016, and September 30, 2019, with a 28-day follow-up. Data were analyzed from November 1, 2019, to July 1, 2020. Intervention: Patients were randomized in a 1:1 ratio to receive either plasma or standard care with normal saline infusion (control). Main Outcomes and Measures: The primary outcome was the international normalized ratio (INR) on arrival at the hospital. Secondary outcomes included the need for massive transfusion and 30-day survival. As a safety outcome, prespecified adverse events included thrombosis, transfusion-related acute lung injury, and transfusion-associated circulatory overload. Results: Among 150 randomized patients, 134 were included in the analysis (median age, 34 [IQR, 26-49] years; 110 men [82.1%]), with 68 in the plasma group and 66 in the control group. Median INR values were 1.21 (IQR, 1.12-1.49) in the plasma group and 1.20 (IQR, 1.10-1.39) in the control group (median difference, -0.01 [IQR, -0.09 to 0.08]; P = .88). The groups did not differ significantly in the need for massive transfusion (7 [10.3%] vs 4 [6.1%]; relative risk, 1.78 [95% CI, 0.42-8.68]; P = .37) or 30-day survival (hazard ratio for death, 1.07 [95% CI, 0.44-2.61]; P = .89). In the full intention-to-treat population (n = 150), the groups did not differ in the rates of any of the prespecified adverse events. Conclusions and Relevance: In this randomized clinical trial including severely injured patients at risk for hemorrhagic shock and associated coagulopathy, prehospital transfusion of lyophilized plasma was not associated with significant differences in INR values vs standard care with normal saline infusion. Nevertheless, these findings show that lyophilized plasma transfusion is a feasible and safe procedure for this patient population. Trial Registration: ClinicalTrials.gov Identifier: NCT02736812.

Automatic external defibrillator provided by unmanned aerial vehicle (drone) in Greater Paris: A real world-based simulation.

AIM: To reduce the delay in defibrillation of out-of-hospital cardiac arrest (OHCA) patients, recent publications have shown that drones equipped with an automatic external defibrillator (AED) appear to be effective in sparsely populated areas. To study the effectiveness of AED-drones in high-density urban areas, we developed an algorithm based on emergency dispatch parameters for the rate and detection speed of cardiac arrests and technical and meteorological parameters. METHODS: We ran a numerical simulation to compare the actual time required by the Basic Life Support team (BLSt) for OHCA patients in Greater Paris in 2017 to the time required by an AED-drone. Endpoints were the proportion of patients with "AED-drone first" and the defibrillation time gained. We built an open-source website (https://airborne-aed.org/) to allow modelling by modifying one or more parameters and to help other teams model their own OHCA data. RESULTS: Of 3014 OHCA patients, 72.2 ±â€¯0.7% were in the "no drone flight" group, 25.8 ±â€¯0.2% in the "AED-drone first" group, and 2.1 ±â€¯0.2% in the "BLSt-drone first" group. When a drone flight was authorized, it arrived an average 190 s before BLSt in 93% of cases. The possibility of flying the drone during the aeronautical night improved the results of the "AED-drone first" group the most (+60%). CONCLUSIONS: In our very high-density urban model, at most 26% of OHCA patients received an AED from an AED-drone before BLSt. The flexible parameters of our website model allows evaluation of the impact of each choice and concrete implementation of the AED-drone.

Dissatisfaction of women with induction of labour according to parity: Results of a population-based cohort study.

OBJECTIVE: To determine the factors associated with dissatisfaction in women whose labour was induced, according to parity. DESIGN: Prospective population-based cohort study. SETTING: Seven French perinatal health networks including 94 maternity units PARTICIPANTS: Among 3042 consecutive women who underwent induction of labour (IoL) with a live foetus from November 17 to December 20, 2015, in participating maternity units, this study included the 1453 who answered the self-administered questionnaire about their experience of IoL at two months post-delivery. MEASUREMENTS: The associations between women's dissatisfaction at two months post-delivery and the characteristics of their pregnancy, labour, and delivery were assessed with multivariable logistic regression models. Analyses were stratified for nulliparous and parous women. Multivariable mixed models were used to take a random effect for the maternity unit into account. FINDINGS: The response rate was 47.8% (n = 1453/3042). Overall, 30% of the nulliparous women were dissatisfied (n = 231/770) and 19.7% (n = 130/659) of the parous women. The specific independent determinants of dissatisfaction for nulliparous women were antenatal birth classes that failed to include discussion of IoL (OR: 2.68, 95% CI [1.37; 5.23]) and lack of involvement in the decision-making process (OR: 1.92, 95% CI [1.23; 3.02]). For the parous women, a specific determinant was a delivery that lasted more than 24 h (OR: 4.04, 95% CI [1.78; 9.14]). Determinants of maternal dissatisfaction common to both groups were unbearable vaginal discomfort (respectively, OR: 1.98, 95% CI [1.16; 3.37] and OR: 4.23, 95% CI [2.04; 8.77]), inadequate pain relief (respectively, OR: 5.55, 95% CI [3.48; 8.86] and OR: 9.17, 95% CI [5.24; 16.02]), lack of attention to requests (respectively OR: 3.81, 95% CI [2.35; 6.19] and OR: 5.01, 95% CI [2.38; 10.52]), caesarean delivery (respectively, OR: 5.55, 95% CI [3.41; 9.03] and OR: 4.61, 95% CI [2.02; 10.53]) and severe maternal complications (respectively, OR: 2.45, 95% CI [1.02; 5.88] and OR: 5.29, 95% CI [1.32; 21.21]). KEY CONCLUSIONS AND IMPLICATIONS FOR PRACTICE: To reduce dissatisfaction in nulliparous women, IoL should be discussed during antenatal birth classes and women should be made to feel that they shared in the medical decision to perform IoL. For parous women, care providers should inform them that the duration of delivery may exceed 24 h. Continuous support for all women during IoL should pay closer attention to vaginal discomfort, pain and women's requests. Postpartum discussions with mothers should be arranged to enable conversation about the experience of unexpected events.

French lyophilized plasma versus normal saline for post-traumatic coagulopathy prevention and correction: PREHO-PLYO protocol for a multicenter randomized controlled clinical trial.

BACKGROUND: Post-trauma bleeding induces an acute deficiency in clotting factors, which promotes bleeding and hemorrhagic shock. However, early plasma administration may reduce the severity of trauma-induced coagulopathy (TIC). Unlike fresh frozen plasma, which requires specific hospital logistics, French lyophilized plasma (FLYP) is storable at room temperature and compatible with all blood types, supporting its use in prehospital emergency care. We aim to test the hypothesis that by attenuating TIC, FLYP administered by prehospital emergency physicians would benefit the severely injured civilian patient at risk for hemorrhagic shock. METHODS/DESIGN: This multicenter randomized clinical trial will include adults severely injured and at risk for hemorrhagic shock, with a systolic blood pressure < 70 mmHg or a Shock Index > 1.1. Two parallel groups of 70 patients will receive either FLYP or normal saline in addition to usual treatment. The primary endpoint is the International Normalized Ratio (INR) at hospital admission. Secondary endpoints are transfusion requirement, length of stay in the intensive care unit, survival rate at day 30, usability and safety related to FLYP use, and other biological coagulation parameters. CONCLUSION: With this trial, we aim to confirm the efficacy of FLYP in TIC and its safety in civilian prehospital care. The study results will contribute to optimizing guidelines for treating hemorrhagic shock in civilian settings. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02736812. Registered on 13 April 2016. The trial protocol has been approved by the French ethics committee (CPP 3342) and the French Agency for the Safety of Medicines and Health Products (IDRCB 2015-A00866-43).

Human immunodeficiency virus-related anemia of chronic disease: relationship to hematologic, immune, and iron metabolism parameters, and lack of association with serum interferon-gamma levels.

Anemia of chronic disease (ACD) is frequent in patients with human immunodeficiency virus (HIV) and its etiology is multifactorial. In a group of 111 patients with HIV, 19 were diagnosed with ACD. Parameters related to iron metabolism, such as serum iron (SI), serum ferritin (SF), and soluble transferrin receptor (sTfR) were correlated to levels of interferon-gamma (IFN-gamma) and results compared to a group of 42 nonanemic patients with HIV. Measurements of erythropoietin (EPO), CD4/CD8 T-cell ratio, and reticulocyte count (RTC) were determined to verify aspects related to severity of disease and bone marrow response. The results showed higher SF concentrations in ACD patients and normal or slightly increased sTfR measurements in both groups. There was no correlation between IFN-gamma and SF and between IFN-gamma and sTfR determinations. Lower CD4/CD8 values were obtained in ACD, and an inverse correlation was observed between IFN-gamma and CD4/CD8 in groups with and without anemia. RTC counts and EPO concentrations were similar in both groups: immature RTC were increased in patients with anemia, indicating an apparent attempt of marrow response to compensate the increased demand. Our data showed no correlation between IFN-gamma levels and iron disturbances in ACD, but results reinforced the observation of enhanced immunologic system deterioration in patients with HIV and ACD.