Ferolles Attilly

Intensive Care Unit (ICU) stays often lead to Swallowing Disorders (SD). Physiological and biomechanical changes due to tracheostomy increase the risk of SD, which can have serious consequences for quality of life and overall health. Experts recommend systematic bedside screening. Most algorithms include the water swallow test followed by expert comprehensive swallowing assessments of screening-positive patients. Early intervention strategies could greatly benefit, highlighting the importance of assessments identifying which specific structures require intervention and enabling a targeted rehabilitation approach. However, clinical examinations lack precision. Complementary examinations, such as videofluoroscopy or Fiberoptic Endoscopic Evaluation of Swallowing (FEES), are irradiating or invasive, consume numerous resources, and are difficult to access. In this context, ultrasound imaging has garnered increased interest for assessing swallowing disorders. Recognized for its non-invasive nature and its ability to overcome conventional constraints, ultrasound holds promise in integrating morphological and dynamically swallowing-related structures evaluation. This approach, enabling both qualitative and quantitative analysis of multiple structures, would enhance precision in targeting structures for rehabilitation. A recent study shows strong potential for an ultrasound prediction model for diagnosing swallowing disorders in outpatients. The researchers intend to create an ultrasound diagnostic model for difficult-to-wean tracheostomized patients. Additionally, they aim to evaluate the reliability and accuracy of this model. Hypothesis: The investigators hypothesize that an ultrasound predictive model is valid and reliable for diagnosing swallowing disorders in difficult-to-wean tracheostomized patients. Main objective: The primary aim is to develop an ultrasound predictive model based on the most relevant ultrasound measurements of the aerodigestive tract. Secondary objectives: * To evaluate the validity and reliability of a new ultrasound score for diagnosing swallowing disorders. * To assess the reliability and validity of tongue movement in diagnosing swallowing disorders. * To evaluate the reliability and validity of hyoid bone movement in diagnosing swallowing disorders. * To assess the reliability and validity of digastric muscle ultrasound evaluation in diagnosing swallowing disorders. * To evaluate the reliability and validity of genohyoid muscle ultrasound evaluation fraction in diagnosing swallowing disorders. Study design: This prospective observational multicenter study will adhere to the ethical standards of the Declaration of Helsinki and will be reported according to the standards for transparent reporting of a multivariable prediction model for individual prognosis or diagnosis guidelines (TRIPOD). Population: One hundred and nineteen difficult-to-wean tracheostomized patients will be enrolled. All consecutive patients with difficult-to-wean tracheostomies will be screened, and those meeting the eligibility criteria will be enrolled. Patients will provide oral consent to participate in accordance with French clinical research laws. Data collection, Fiberoptic Endoscopic Evaluation of Swallowing (FEES), and ultrasound (US) evaluations will be conducted within a two-hour timeframe. Data collection: Data will be recorded using an online case report form (Datacapt). Demographic data, comorbidities, medical, and surgical history will be recorded at enrollment. On-site monitoring is planned monthly. Ultrasound examination: Ultrasonography will be performed using both linear and convex probes. The ultrasonographer will be blinded to the patient's status and prior clinical or imaging assessments. All measurements will be performed in a semi-recumbent position (30°) with the neck in a neutral position. Subjects will be asked to swallow saliva to assess active movements and muscle contractions. Parameters such as tongue thickness, movement, and echointensity, hyoid bone movement, and suprahyoid muscle characteristics (thickness, cross-sectional area, and echointensity) will be evaluated. Suprahyoid muscles will be assessed both at rest and during swallowing, and muscle contraction ratios will be calculated accordingly. Detailed information on the ultrasound procedure is described in the research protocol. To assess inter-examiner reliability, during the initial ultrasound evaluation, tests will be conducted by two different operators on a consecutive sample of patients. To limit the examination time for each patient, another consecutive sample of patients will be used for intra-examiner reliability. For the patients involved in the reliability assessment, an additional 10 minutes will be allocated. FEES: They will be performed by the attending physician in the patient's room. A physiotherapist or speech-language therapist will be present to assess swallowing and the involved structures systematically. Evaluators will examine the integrity and functionality of structures such as the arytenoids or vocal cords, and assess laryngeal and hypopharyngeal sensitivity. The examination will conclude with swallowing trials using various textures to observe swallowing, enabling identification of any inhalation. Different bolus consistencies, viscosities, and volumes will be used during the assessment to evaluate the patient's full range of dietary options, based on preswallow assessments. The Yale Pharyngeal Residue Severity Rating Scale will be used to characterize the severity and localization of residues observed after each swallowing trial. Statistical plan: Descriptive statistics will summarize quantitative variables with means (± standard deviation) or medians \[minimum-maximum\], while qualitative variables will be described using numbers and percentages. Univariate comparisons will employ standard statistical tests, such as Chi-square, Fisher's test, t-test, ANOVA, Wilcoxon, or Kruskal-Wallis tests, with a significance level of 5% and 95% confidence intervals. Association measures between variables will use Pearson's or Spearman's correlation coefficients for quantitative data and Chi-square or Fisher's tests for qualitative data. Agreement assessment will utilize the Bland-Altman method for quantitative variables and the Kappa coefficient for qualitative variables. To establish an ultrasound diagnostic model for diagnosing swallowing disorders, variables will be dichotomized based on a linear relationship hypothesis tested using ROC curve analysis. Patients will be categorized into positive (presence of swallowing disorders) and negative groups (absence of swallowing disorders) using FEES diagnosis. Ultrasound variables differing significantly between these groups (p \< 0.20) will be included in multivariate logistic regression, guided by Akaike's information criterion (AIC) for variable selection while considering multicollinearity. The multivariate logistic regression scores will weight each ultrasound variable. Researchers will transform the model into an easy-to-use scoring system. Validity will be determined by ROC curve analysis to establish the ultrasound score threshold for diagnosing swallowing disorders. Sensitivities, specificities, positive and negative predictive values, and diagnostic odds ratios will assess the score's diagnostic accuracy. Reliability, assessed with a correlation coefficient (ρ=0.80), requires a sample of 20 patients for a desired correlation coefficient (ρ0=0.50), ensuring sufficient power (α=0.05, β=0.20). Inter- and intra-examiner reproducibility will be evaluated using the Kappa coefficient. Sample size calculation: According to Harrell's recommendations on the construction of multivariate models, a maximum of 1 variable per 10 events should be included. The prevalence of swallowing disorders in our patient population is highly variable in the literature (e.g., 11-93% according to Skoretz or 50-83% according to Garuti et al). Based on our PMSI data, we estimate the prevalence of swallowing disorders at 65%. We aim to include a maximum of 4 variables in the multivariate model, i.e., 114 patients are required.

The implementation of therapeutic cooking workshops during the management of obesity in hospitals is now well accepted and recognized as of potential interest on the nutritional level but also cognitive and social (DESPORT, 2015; DAGONEAU, 2008). The literature shows that adults participating in cooking workshops are satisfied and acquire cooking skills potentially useful for improving their health (WOLFSON, BLEICH, 2015; CARAHER, 1999). REICKS (2014, 2018) and REES (2012) point out, however, the low methodological quality of most of the studies conducted and, in fact, the effectiveness of therapeutic cooking workshops has not been formally demonstrated by rigorous randomized studies. The Care and Prevention Research Unit (CRESP) of the Manhès Hospital Center then built a multicenter research protocol to demonstrate the impact of cooking workshops in the care of patients with obesity. The protocol involves 6 hospitals: Georges Pompidou European Hospital (HEGP) University Hospital Center (department of Prof S. CZERNICHOW), PITIE SALPETRIERE University Hospital Center (department of Prof J.M. OPPERT), Cognacq Jay Hospital Center, Forcilles Hospital Center, Bligny Hospital Center and Manhes Hospital Center . The CuisTO protocol was selected by the PHRIP Jury of the DGOS (General Direction of the Care Offer French Ministry of Health) in 2019 as a high priority project. The main objective of this research is to evaluate the effectiveness of remote cooking workshops in the management of obesity, through two methods of setting up therapeutic cooking workshops (so-called "classic" workshops and workshops in the form of "culinary challenges") to improve dietary balance in the context of the care of adult patients living with obesity. Dietary balance will be estimated by compliance with the recommendations of the latest National Health Nutrition Program (PNNS-4 2019-2023), "judged" by the PNNS-GS2 score, the consumption of fruits and vegetables, the frequency of cooking and a reduction in the consumption of ultra-processed dishes that have already been prepared. This is a multicentre, open-label, controlled, comparative intervention study with sequential randomization in clusters (clusters) of the "stepped wedge" type

The aim of the study is to show that auriculotherapy is effective in the treatment of xerostomia

The main aim of this study was to determine the prevalence of Tapia syndrome in patients admitted to weaning unit after prolonged (\>48h) orotracheal intubation in the ICU. The secondary objectives are to: * Describe the clinical semiology of Tapia syndrome : lingual involvement, soft palate involvement, impairment of phonation and swallowing ; * Describe the paraclinical features of Tapia syndrome: recurrent involvement, laryngeal and lingual involvement; * Identify factors associated with Tapia's syndrome

Radiotherapy for head and neck cancers increases the risk of Swallowing Disorders (SD), which can have serious consequences for nutrition, quality of life, and overall health. Early intervention strategies could greatly benefit, highlighting the importance of assessments offering insights into patients' prognosis, identifying which specific structures require intervention and enabling a targeted rehabilitation approach. However, the clinical examination lacks precision. Complementary examinations, such as videofluoroscopy or Fiberoptic Endoscopic Evaluation of Swallowing (FEES), are irradiating or invasive, consume numerous resources and are difficult to access. What's more, their prognostic values are not known. In this context, ultrasound imaging has garnered increased interest for assessing swallowing disorders. Recognised for its non-invasive nature and its ability to overcome conventional constraints, ultrasound holds promise in integrating morphological and dynamically swallowing-related structures evaluation. This approach, enabling both qualitative and quantitative analysis of multiple structures, would enhance the precision in targeting structures for rehabilitation. The researchers intend to create an ultrasound predictive model to anticipate the risk of developing swallowing disorders during head and neck cancer radiotherapy. Hypothesis : The investigators hypothesize that one or more ultrasound variables are independently associated with swallowing disorder development and worsening nutritional status during radiotherapy treatment for head and neck cancer. Objectives Main objective : The main objective of this study is to evaluate the predictive capacity of different ultrasound markers of the VADS on the incidence of TD during radiotherapy treatment for CTC Secondary objectives : In a population of patients treated with radiotherapy for CTC : * Assessing the reliability of ultrasound measurements ; * Evaluate the feasibility of ultrasound measurements; * To evaluate the predictive ability of the change in ultrasound markers after 1 and 2 weeks of radiotherapy on the incidence of TD ; * To determine whether ultrasound markers associated with the onset of TD improve a predictive model including known predictors ; * Assessing the association between ultrasound markers and the incidence of undernutrition; * To evaluate the predictive ability of the change in ultrasound markers after 1 and 2 weeks of radiotherapy on the incidence of undernutrition ; * Evaluate the association between ultrasound markers and quality of life in relation to TD. Study design : Prospective, observational single-centre study will be performed per the ethical standards of the Declaration of Helsinki and will be reported following the standards for the transparent reporting of a multivariable prediction model for individual prognosis or diagnosis guidelines (TRIPOD) Population : One hundred and twenty-four outpatients starting a radiotherapy treatment for head and neck cancer will be enrolled at Radiotherapy Services at Forcilles's Hospital, during a eighteen-months period. All consecutive patients will be screened at admission, and will be included if they satisfy the eligibility criteria. All patients will provide oral consent to participate, by the clinical research French laws. The patient's participation will be equivalent to the duration of their radiotherapy treatment. The maximum additional time needed for research interventions is 40 minutes. Data collection : Data will be recorded using an online case report form (Datacapt). Demographic data, comorbidities, medical and surgical history will be recorded at inclusion. Clinical, videoflyoroscopy and ultrasound measurements will also be recorded. On-site monitoring is planned every month. The ultrasound examination will be conducted initially, on the seventh and fourteenth days of radiotherapy, always preceding other swallowing evaluations. Ultrasound examination : Ultrasonography will be performed using a Sonosite E2 Expert ultrasound device (Digital Color Doppler Ultrasound System ; Sonoscape medical corp. China) with a 7-10 MHz linear and a 3-5 MHz probes. Detailed information for ultrasound procedure is described in the research protocol. Ultrasonography will be performed with the patients in near-to-supine position (30°). To assess the value of variation in these examinations during radiotherapy as a predictive factor, a total of three ultrasound examinations will be performed prior to the first radiotherapy treatment and after seven and fourteen days. Ultrasonographers will be blinded from all patients' status and previous examination. Ultrasound evaluation will focus on the movements or morphology of structures such as the tongue, laryngeal movement, or suprahyoid muscles. In order to assess inter-examiner reliability, and only during the first ultrasound evaluation, the tests will be carried out by two different operators on a consecutive sample of patients. To limit the examination time for each patient, the investigators will use another consecutive sample of patients for intra-examiner reliability. For the patients making up the samples used for reliability assessment, only 10' extra will be added. Clinical evaluation All patients will undergo a standardized weekly clinical assessment conducted by a speech language therapist. This assessment will involve an analytical evaluation of various structures (tongue movement and strength, laryngeal movement, etc.) and swallowing tests following the volume-viscosity swallow test. Videofluoroscopy : VFSS is a radiographic procedure offering a dynamic view of oral, pharyngeal, and upper esophageal function during swallowing. The radiologist and speech-language therapist collaborate to realise these evaluations. Barium-mixed food and fluid aid visibility via videofluoroscopy. The examiner must evaluate the broadest range of the patient's feeding options, starting with the safest quantity and texture. VFSS assesses swallow characteristics, bolus movement patterns, initiation, nasopharyngeal reflux, pharyngeal clearance, laryngeal penetration, and aspiration. At any time, examiners may halt the evaluation if deemed harmful, with reasons recorded. In instances of penetration or aspiration, the speech-language therapist employs the 'Penetration-Aspiration Scale.' Statistical plan : The study aims to assess the prognostic value of swallowing ultrasound in predicting the occurrence of swallowing disorders (TDs) during radiotherapy for CTC treatment. The event under consideration is the development of TDs between patient inclusion and the completion of radiotherapy. The analysis involves investigating the relationship between variables and TD occurrence. Quantitative variables in multivariate models will be studied using restricted cubic splines and fractional polynomial methods for accurate assessment. Variable selection for the TD predictive model includes testing the prognostic values of ultrasound variables and adjustment variables through univariate Cox models. Significant variables (p ≤ 0.10) or those with known prognostic impact will be included in a multivariate Cox model. Model calibration, discrimination, and internal validation will be evaluated using the c-index, graphical calibration at 30 days, and the bootstrap method. The estimation of TD onset times will utilize the Kaplan-Meier method, comparing survival curves between groups defined by ultrasound variable thresholds with the log-rank test. A prognostic score will be constructed from multivariate model results, categorizing patients into low-risk, intermediate-risk, and high-risk groups. Thresholds for categorization will be determined using Cox's method. Handling missing data involves either deleting observations with missing data or using data imputation methods depending on the origin and type of missing data. Reproducibility assessment of ultrasound measurements includes inter-operator and intra-operator evaluations. To assess inter-operator reproducibility, measurements by two different operators will be compared, while intra-operator reproducibility will be evaluated from measurements performed by the same operator 30 minutes apart. A sample size of 40 patients is deemed necessary for reproducibility assessment based on Walter et al.'s methodology. The tests will be performed at a significance level of 5%. 95% confidence intervals will be provided for each estimate. Calculations will be performed using SPSS v21 IBM and R software (version 3.6.1, www.R-project.org). Sample size calculation : According to Harrell's recommendations on the construction of multivariate models, a maximum of 1 variable per 10 events should be included. The investigators estimates the incidence of swallowing disorders in our patient population at 45% according to the literature. The investigators aims to include a maximum of 5 variables in the multivariate model, i.e. 112 patients required. Among the eligible patient population, taking into account a 10% loss-of-sight rate, it is necessary to include 124 patients

Colorectal cancer occurs mainly in elderly patients. Recent estimation showed that in France more than 50% of the patients diagnosed with a colorectal cancer are 70 years old or more. Adjuvant chemotherapy has demonstrated a benefit on disease-free survival and overall survival after a stage III colon cancer resection. Nevertheless adjuvant chemotherapy is poorly used in elderly patients. Prognostic improvement with chemotherapy based on 5FU is suggested by a post-hoc analysis of randomized prospective clinical trial. But elderly patients in this study were highly selected and patients older than 80 represented only 0.7% of the total population. Thus, there is still a concern about the benefit of adjuvant 5FU-based chemotherapy in very elderly unselected patients. The recommended treatment for stage III adjuvant chemotherapy is a combination of fuoropyrimidine and oxaliplatin. Nevertheless oxaliplatin did not demonstrated survival advantage in elderly patients. Altogether there are still two matters of debate: * First, is there a benefit of fluoropyrimidine-based adjuvant chemotherapy for unfit elderly patients? * Second, is there a benefit of oxaliplatin-based adjuvant chemotherapy for fit elderly patients? The aim of this randomized phase III study is to evaluate the benefit for disease-free survival of adjuvant chemotherapy in elderly patient and which chemotherapy. The elderly patient population will be dichotomized into two groups according to physician's choice after a multidisciplinary evaluation involving a geriatrician, with two different randomization assignments. The patients with an expected life-expectancy below 4 years according Lee score are excluded of this study. Some biological tumour abnormalities are more frequently observed in elderly (i.e. mismatch repair deficiency), therefore an evaluation of specific biological prognostic factors is needed in elderly population.