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  1. Article ; Online: Effect of superficial and deep parasternal blocks on recovery after cardiac surgery

    Audrey Jeanneteau / Achille Demarquette / Aymeric Blanchard-Daguet / Olivier Fouquet / Sigismond Lasocki / Jérémie Riou / Emmanuel Rineau / Maxime Léger

    Trials, Vol 24, Iss 1, Pp 1-

    study protocol for a randomized controlled trial

    2023  Volume 10

    Abstract: Abstract Background Pain is frequent after cardiac surgery and source of multiple complications that can impair postoperative recovery. Regional anesthesia seems to be an interesting technique to reduce the pain in this context, but its effectiveness in ... ...

    Abstract Abstract Background Pain is frequent after cardiac surgery and source of multiple complications that can impair postoperative recovery. Regional anesthesia seems to be an interesting technique to reduce the pain in this context, but its effectiveness in improving recovery has been poorly studied so far. The objective of this study is to compare the effectiveness of two of the most studied chest wall blocks in cardiac surgery, i.e., the superficial and the deep parasternal intercostal plane blocks (SPIP and DPIP respectively), in addition to standard care, versus the standard care without regional anesthesia, on the quality of postoperative recovery (QoR) after cardiac surgery with sternotomy. Methods This is a single-center, single-blind, controlled, randomized trial with a 1:1:1 ratio. Patients (n = 254) undergoing cardiac surgery with sternotomy will be randomized into three groups: a control group with standard care and no regional anesthesia, a SPIP group with standard care and a SPIP, and a DPIP with standard care and a DPIP. All groups will receive the usual analgesic protocol. The primary endpoint is the value of the QoR evaluated by the QoR-15 at 24 h after the surgery. Discussion This study will be the first powered trial to compare the SPIP and the DPIP on global postoperative recovery after cardiac surgery with sternotomy. Trial registration ClinicalTrials.gov NCT05345639. Registered on April 26, 2022.
    Keywords Cardiac surgery ; Anesthesia ; Regional anesthesia ; Quality of recovery ; Patient related outcomes ; Superficial parasternal intercostal plane block ; Medicine (General) ; R5-920
    Subject code 610
    Language English
    Publishing date 2023-07-01T00:00:00Z
    Publisher BMC
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  2. Article ; Online: Safety of changes in the use of noninvasive ventilation and high flow oxygen therapy on reintubation in a surgical intensive care unit

    Stanislas Abrard / Lorine Jean / Emmanuel Rineau / Pauline Dupré / Maxime Léger / Sigismond Lasocki

    PLoS ONE, Vol 16, Iss 3, p e

    A retrospective cohort study.

    2021  Volume 0249035

    Abstract: Reintubation after weaning from mechanical ventilation is relatively common and is associated with poor outcomes. Different methods to decrease the reintubation rate post extubation, including noninvasive ventilation, and more recently high-flow oxygen ( ... ...

    Abstract Reintubation after weaning from mechanical ventilation is relatively common and is associated with poor outcomes. Different methods to decrease the reintubation rate post extubation, including noninvasive ventilation, and more recently high-flow oxygen (HFO) therapy, have been proposed. In this study, we aimed to assess the safety of introducing HFO in the post-extubation care of intensive care unit (ICU) patients. We conducted a single-center cohort study of extubated adult patients hospitalized in a surgical ICU and previously mechanically ventilated for > 1 day. Our study consisted of two phases: Phase 1 (before the introduction of HFO from April 2015 to April 2016) and Phase P2 (after the introduction of HFO from April 2017 to April 2018). The primary endpoint was the reintubation rate within 48 hours of extubation. In total, 290 patients (median age 65 years [50-74]; 190 men [65.5%]) were included in the analysis (181 and 109 in Phases 1 and 2, respectively). The results of the post-extubation use of noninvasive methods (noninvasive ventilation and/or HFO) were not significantly different between the two phases (41 [22.7%] versus 29 [26.6%] patients; p = 0.480), however these methods were implemented earlier in Phase 2 (0 versus 4 hours; p = 0.009) and HFO was used significantly more often than noninvasive ventilation (24 [22.0%] versus 25 [13.8%] patients; p = 0.039). The need for reintubation within 48 hours post extubation was significantly lower in Phase 2 (4 [3.7%] versus 20 [11.0%] patients; p = 0.028) but was not significantly different at 7 days post extubation (10 [9.2%] versus 30 [16.6%] patients; p = 0.082). The earlier implementation of noninvasive methods and the increased use of HFO beginning in Phase 2 were safe and effective based on the reintubation rates within the first 48 hours post extubation and after 7 days.
    Keywords Medicine ; R ; Science ; Q
    Subject code 610
    Language English
    Publishing date 2021-01-01T00:00:00Z
    Publisher Public Library of Science (PLoS)
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  3. Article ; Online: G-computation and machine learning for estimating the causal effects of binary exposure statuses on binary outcomes

    Florent Le Borgne / Arthur Chatton / Maxime Léger / Rémi Lenain / Yohann Foucher

    Scientific Reports, Vol 11, Iss 1, Pp 1-

    2021  Volume 12

    Abstract: Abstract In clinical research, there is a growing interest in the use of propensity score-based methods to estimate causal effects. G-computation is an alternative because of its high statistical power. Machine learning is also increasingly used because ... ...

    Abstract Abstract In clinical research, there is a growing interest in the use of propensity score-based methods to estimate causal effects. G-computation is an alternative because of its high statistical power. Machine learning is also increasingly used because of its possible robustness to model misspecification. In this paper, we aimed to propose an approach that combines machine learning and G-computation when both the outcome and the exposure status are binary and is able to deal with small samples. We evaluated the performances of several methods, including penalized logistic regressions, a neural network, a support vector machine, boosted classification and regression trees, and a super learner through simulations. We proposed six different scenarios characterised by various sample sizes, numbers of covariates and relationships between covariates, exposure statuses, and outcomes. We have also illustrated the application of these methods, in which they were used to estimate the efficacy of barbiturates prescribed during the first 24 h of an episode of intracranial hypertension. In the context of GC, for estimating the individual outcome probabilities in two counterfactual worlds, we reported that the super learner tended to outperform the other approaches in terms of both bias and variance, especially for small sample sizes. The support vector machine performed well, but its mean bias was slightly higher than that of the super learner. In the investigated scenarios, G-computation associated with the super learner was a performant method for drawing causal inferences, even from small sample sizes.
    Keywords Medicine ; R ; Science ; Q
    Subject code 310
    Language English
    Publishing date 2021-01-01T00:00:00Z
    Publisher Nature Portfolio
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  4. Article ; Online: Impact on Postoperative Pain and Recovery of a Regional Analgesia Strategy Based on the Surgical Approach for Lung Resection

    Marion Trouillard / William Dupuis / Hélène Siaudeau / Florian Denou / Emmanuelle Longeau / Maxime Léger / Myriam Ammi / Cyril Sargentini / Sigismond Lasocki / Emmanuel Rineau

    Journal of Clinical Medicine, Vol 11, Iss 1376, p

    A Prospective Observational Study

    2022  Volume 1376

    Abstract: Various regional anesthesia (RA) techniques were shown to reduce pain after lung surgery, but controversies remain regarding the best technique to use to improve recovery. In this observational prospective study, the aim was to assess the efficacy of an ... ...

    Abstract Various regional anesthesia (RA) techniques were shown to reduce pain after lung surgery, but controversies remain regarding the best technique to use to improve recovery. In this observational prospective study, the aim was to assess the efficacy of an RA strategy depending on the surgical approach. Patients who underwent lung surgery were included if an RA was planned following our unit procedure (erector spinae plane block (ESP) for video-assisted thoracic surgery (VATS) and thoracic epidural analgesia (TEA) or intrathecal analgesia (IA) for thoracotomy). Patients were compared according to the RA used. In total, 116 patients were included, 70 (60%), 32 (28%), 14 (12%) in the ESP, TEA and IA groups, respectively. Between Day 1 and Day 3, median NRS values were ≤4 at rest, and <50% patients experienced moderate-to-severe pain in each group. There were no significant differences in opioid consumption and in pain at rest or during chest physiotherapy on Days 1 and 2 between groups. However, patients who received an IA had lower NRS than other groups on Day 0 and 3 and a shorter length of hospital stay in comparison with those who received a TEA. Thus, in our institution, a strategy combining ESP for VATS and TEA, or IA for thoracotomy, allowed for effective analgesia after a lung resection. Interestingly, IA appeared to be more effective than TEA in reducing the length of hospital stay and pain on Day 0 and 3.
    Keywords postoperative pain ; postoperative recovery ; epidural analgesia ; intrathecal analgesia ; erector spinae plane block ; lung surgery ; Medicine ; R
    Subject code 610
    Language English
    Publishing date 2022-03-01T00:00:00Z
    Publisher MDPI AG
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  5. Article ; Online: Methodological quality of multivariate prognostic models for intracranial haemorrhages in intensive care units

    Denis Frasca / Fanny Feuillet / Maxime Leger / Raphaël Cinotti / Yohann Foucher / Jeanne Simon-Pimmel / Laetitia Bodet-Contentin / Etienne Dantan

    BMJ Open, Vol 11, Iss

    a systematic review

    2021  Volume 9

    Keywords Medicine ; R
    Language English
    Publishing date 2021-09-01T00:00:00Z
    Publisher BMJ Publishing Group
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  6. Article ; Online: The effect of opioid-free anesthesia protocol on the early quality of recovery after major surgery (SOFA trial)

    Maxime Léger / Solène Pessiot-Royer / Tristan Perrault / Elsa Parot-Schinkel / Fabienne Costerousse / Emmanuel Rineau / Sigismond Lasocki

    Trials, Vol 22, Iss 1, Pp 1-

    study protocol for a prospective, monocentric, randomized, single-blinded trial

    2021  Volume 10

    Abstract: Abstract Background Since the 2000s, opioid-free anesthesia (OFA) protocols have been spreading worldwide in anesthesia daily practice. These protocols avoid using opioid drugs during anesthesia to prevent short- and long-term opioid side effects while ... ...

    Abstract Abstract Background Since the 2000s, opioid-free anesthesia (OFA) protocols have been spreading worldwide in anesthesia daily practice. These protocols avoid using opioid drugs during anesthesia to prevent short- and long-term opioid side effects while ensuring adequate analgesic control and optimizing postoperative recovery. Proofs of the effect of OFA protocol on optimizing postoperative recovery are still scarce. The study aims to compare the effects of an OFA protocol versus standard anesthesia protocol on the early quality of postoperative recovery (QoR) from major surgeries. Methods The SOFA trial is a prospective, randomized, parallel, single-blind, monocentric study. Patients (n = 140) scheduled for major plastic, visceral, urologic, gynecologic, or ear, nose, and throat (ENT) surgeries will be allocated to one of the two groups. The study group (OFA group) will receive a combination of clonidine, magnesium sulfate, ketamine, and lidocaine. The control group will receive a standard anesthesia protocol based on opioid use. Both groups will receive others standard practices for general anesthesia and perioperative care. The primary outcome measure is the QoR-15 value assessed at 24 h after surgery. Postoperative data such as pain intensity, the incidence of postoperative complication, and opioid consumption will be recorded. We will also collect adverse events that may be related to the anesthetic protocol. Three months after surgery, the incidence of chronic pain and the quality of life will be evaluated by phone interview. Discussion This will be the first study powered to evaluate the effect of OFA versus a standard anesthesia protocol using opioids on global postoperative recovery after a wide range of major surgeries. The SOFA trial will also provide findings concerning the OFA impact on chronic pain incidence and long-term patient quality of life. Trial registration ClinicalTrials.gov NCT04797312. Registered on 15 March 2021
    Keywords Anesthesia ; Opioid-free anesthesia ; Opioid-related adverse effects ; Quality of recovery ; Quality of life ; Perioperative care ; Medicine (General) ; R5-920
    Language English
    Publishing date 2021-11-01T00:00:00Z
    Publisher BMC
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  7. Article ; Online: Cognitive Aid for Anesthetic Preparation in An Emergency Situation

    Emmanuel Rineau / Anna Collard / Lorine Jean / Sarah Guérin / Louise Maunoury / Ludovic Martin / Sigismond Lasocki / Maxime Léger

    Healthcare, Vol 9, Iss 1646, p

    A Simulation-Based Study

    2021  Volume 1646

    Abstract: When anesthesia checklists and preparations are performed urgently, omissions may occur and be deleterious to the patient. The aim of this study was to evaluate in simulation the interest of a cognitive aid to effectively prepare an anesthetic room for ... ...

    Abstract When anesthesia checklists and preparations are performed urgently, omissions may occur and be deleterious to the patient. The aim of this study was to evaluate in simulation the interest of a cognitive aid to effectively prepare an anesthetic room for an emergency. In a prospective single-center simulation-based study, 32 anesthesia residents had to prepare an anesthetic room in an emergency scenario, without cognitive aid in the first phase. Three months later (phase 2), they were randomly assigned to receive a cognitive aid (aid group) or no additional aid (control) and were involved in the same scenario. The primary outcome was the validation rate of each essential item in the first 5 min in phase 2. Eight items were significantly more frequently completed in the first 5 min in the aid group in phase 2 (vs. phase 1), compared with two only in the control group. However, there were no significant differences in the overall number of completed items between the two groups, as both groups completed significantly more items in phase 2, either in the first 5 min (19 (14–23) vs. 13 (9–15) in phase 1 for all residents, p < 0.001) or without time limit. Preparation times were reduced in phase 2 in both groups. In conclusion, the use of a cognitive aid allowed anesthesia residents to complete some safety items of a simulated urgent anesthesia preparation more frequently. In addition, despite daily clinical experience, a single simulation session improved anesthesia preparation and reduced the preparation time with or without cognitive aid.
    Keywords patient safety ; anesthesia ; checklist ; cognitive aid ; emergency ; simulation ; Medicine ; R
    Language English
    Publishing date 2021-11-01T00:00:00Z
    Publisher MDPI AG
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  8. Article ; Online: Early use of barbiturates is associated with increased mortality in traumatic brain injury patients from a propensity score-based analysis of a prospective cohort.

    Maxime Léger / Denis Frasca / Antoine Roquilly / Philippe Seguin / Raphaël Cinotti / Claire Dahyot-Fizelier / Karim Asehnoune / Florent Le Borgne / Thomas Gaillard / Yohann Foucher / Sigismond Lasocki / for AtlanRéa group

    PLoS ONE, Vol 17, Iss 5, p e

    2022  Volume 0268013

    Abstract: Barbiturates are proposed as a second/third line treatment for intracranial hypertension in traumatic brain injury (TBI) patients, but the literature remains uncertain regarding their benefit/risk balance. We aimed to evaluate the impact of barbiturates ... ...

    Abstract Barbiturates are proposed as a second/third line treatment for intracranial hypertension in traumatic brain injury (TBI) patients, but the literature remains uncertain regarding their benefit/risk balance. We aimed to evaluate the impact of barbiturates therapy in TBI patients with early intracranial hypertension on the intensive care unit (ICU) survival, the occurrence of ventilator-associated pneumonia (VAP), and the patient's functional status at three months. We used the French AtlanREA prospective cohort of trauma patients. Using a propensity score-based methodology (inverse probability of treatment weighting), we compared patients having received barbiturates within the first 24 hours of admission (barbiturates group) and those who did not (control group). We used cause-specific Cox models for ICU survival and risk of VAP, and logistic regression for the 3-month Glasgow Outcome Scale (GOS) evaluation. Among the 1396 patients with severe trauma, 383 had intracranial hypertension on admission and were analyzed. Among them, 96 (25.1%) received barbiturates. The early use of barbiturates was significantly associated with increased ICU mortality (HR = 1.85, 95%CI 1.03-3.33). However, barbiturates treatment was not significantly associated with VAP (HR = 1.02, 95%CI 0.75-1.41) or 3-month GOS (OR = 1.67, 95%CI 0.84-3.33). Regarding the absence of relevant clinical trials, our results suggest that each early prescription of barbiturates requires a careful assessment of the benefit/risk ratio.
    Keywords Medicine ; R ; Science ; Q
    Subject code 616 ; 610
    Language English
    Publishing date 2022-01-01T00:00:00Z
    Publisher Public Library of Science (PLoS)
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  9. Article ; Online: G-computation, propensity score-based methods, and targeted maximum likelihood estimator for causal inference with different covariates sets

    Arthur Chatton / Florent Le Borgne / Clémence Leyrat / Florence Gillaizeau / Chloé Rousseau / Laetitia Barbin / David Laplaud / Maxime Léger / Bruno Giraudeau / Yohann Foucher

    Scientific Reports, Vol 10, Iss 1, Pp 1-

    a comparative simulation study

    2020  Volume 13

    Abstract: Abstract Controlling for confounding bias is crucial in causal inference. Distinct methods are currently employed to mitigate the effects of confounding bias. Each requires the introduction of a set of covariates, which remains difficult to choose, ... ...

    Abstract Abstract Controlling for confounding bias is crucial in causal inference. Distinct methods are currently employed to mitigate the effects of confounding bias. Each requires the introduction of a set of covariates, which remains difficult to choose, especially regarding the different methods. We conduct a simulation study to compare the relative performance results obtained by using four different sets of covariates (those causing the outcome, those causing the treatment allocation, those causing both the outcome and the treatment allocation, and all the covariates) and four methods: g-computation, inverse probability of treatment weighting, full matching and targeted maximum likelihood estimator. Our simulations are in the context of a binary treatment, a binary outcome and baseline confounders. The simulations suggest that considering all the covariates causing the outcome led to the lowest bias and variance, particularly for g-computation. The consideration of all the covariates did not decrease the bias but significantly reduced the power. We apply these methods to two real-world examples that have clinical relevance, thereby illustrating the real-world importance of using these methods. We propose an R package RISCA to encourage the use of g-computation in causal inference.
    Keywords Medicine ; R ; Science ; Q
    Subject code 310
    Language English
    Publishing date 2020-06-01T00:00:00Z
    Publisher Nature Portfolio
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  10. Article ; Online: Association of preoperative COVID-19 and postoperative respiratory morbidity during the Omicron epidemic wave

    Marc Garnier / Jean-Michel Constantin / Raphaël Cinotti / Chafia Daoui / Dimitri Margetis / Grégory Destruhaut / Cédric Cirenei / Eric Noll / Christophe Quesnel / Agnes Lecinq / Sigismond Lasocki / Hélène Charbonneau / Stanislas Abrard / Cyril Quemeneur / Bruno Pastene / Nathanaël Lapidus / Marc Leone / El Mahdi Hafiani / Olivier Imauven /
    Emmanuel Rineau / Maxime Léger / Marc Danguy des Deserts / Johan Schmitt / Philippe Aries / Aurélie Gouel / Julia Voulgaropoulos / Laura Soldan / Romain Deransy / Quentin Laurent / Etienne Gayat / Franck Verdonk / Sabrina Chaouche / Amélie Cambriel / Vincent Degos / Julie Dupont / Laura Daoud / Romain Salettes / Malory Favreau / Julien Pottecher / Sophie Diemunsch

    EClinicalMedicine, Vol 58, Iss , Pp 101881- (2023)

    the DROMIS-22 multicentre prospective observational cohort studyResearch in context

    2023  

    Abstract: Summary: Background: Preoperative COVID-19 has been associated with excess postoperative morbi-mortality. Consequently, guidelines were developed that recommended the postponement of surgery for at least 7 weeks after the infection. We hypothesised that ... ...

    Abstract Summary: Background: Preoperative COVID-19 has been associated with excess postoperative morbi-mortality. Consequently, guidelines were developed that recommended the postponement of surgery for at least 7 weeks after the infection. We hypothesised that vaccination against the SARS-CoV-2 and the large predominance of the Omicron variant attenuated the effect of a preoperative COVID-19 on the occurrence of postoperative respiratory morbidity. Methods: We conducted a prospective cohort study in 41 French centres between 15 March and 30 May 2022 (ClinicalTrials NCT05336110), aimed at comparing the postoperative respiratory morbidity between patients with and without preoperative COVID-19 within 8 weeks prior to surgery. The primary outcome was a composite outcome combining the occurrence of pneumonia, acute respiratory failure, unexpected mechanical ventilation, and pulmonary embolism within the first 30 postoperative days. Secondary outcomes were 30-day mortality, hospital length-of-stay, readmissions, and non-respiratory infections. The sample size was determined to have 90% power to identify a doubling of the primary outcome rate. Adjusted analyses were performed using propensity score modelling and inverse probability weighting. Findings: Of the 4928 patients assessed for the primary outcome, of whom 92.4% were vaccinated against the SARS-CoV-2, 705 had preoperative COVID-19. The primary outcome was reported in 140 (2.8%) patients. An 8-week preoperative COVID-19 was not associated with increased postoperative respiratory morbidity (odds ratio 1.08 [95% CI 0.48–2.13]; p = 0.83). None of the secondary outcomes differed between the two groups. Sensitivity analyses concerning the timing between COVID-19 and surgery, and the clinical presentations of preoperative COVID-19 did not show any association with the primary outcome, except for COVID-19 patients with ongoing symptoms the day of surgery (OR 4.29 [1.02–15.8]; p = 0.04). Interpretation: In our Omicron-predominant, highly immunised population undergoing ...
    Keywords COVID-19 ; Anaesthesia ; Surgery ; Perioperative risk ; Respiratory complications ; Postoperative pneumonia ; Medicine (General) ; R5-920
    Subject code 610
    Language English
    Publishing date 2023-04-01T00:00:00Z
    Publisher Elsevier
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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