Study of Sleep Quality in the Intensive Care Unit and Association with Weaning from Invasive Ventilation in Patients with Chronic Obstructive Bronchopneumopathy.

Patients admitted in ICU may require invasive mechanical ventilation, using a mechanical ventilator and an endotracheal tube.
In ICU, a prolonged duration of invasive mechanical ventilation may be responsible for ventilator-induced lung injury, pulmonary infection, prolonged administration of sedation, neuromyopathy and prolonged length of stay. The goal of the ICU healthcare teams is therefore to reduce the duration of invasive mechanical ventilation as much as possible.
ICU patients have many sleep disturbances: sleep fragmentation, sleep stage changes, changes in sleep architecture. These sleep disturbances are due to sedation and analgesia, delirium, patient care activities, noise and altered day-night cycles.
Chronic obstructive pulmonary disease (COPD) is a common respiratory disease. COPD complicates the management of invasive mechanical ventilation, particularly weaning of this invasive mechanical ventilation and extubation (removal of the intubation tube).
To reduce the risk of reintubation, it is recommended that a weaning test is performed prior to extubation. The purpose of this test is to simulate the conditions of breathing without the help of a ventilator after extubation. If the weaning test is successful, the patient can theoretically be extubated.
There are several causes associated with extubation failure, but studies suggest that sleep deprivation or poor sleep quality in the nights before extubation is one of them. In addition, patients with COPD often have chronic sleep disturbances or induced by their stay in the ICU (asthenia, bed rest, anxiety, sedation, etc.).
The aim of our study will be to compare the sleep characteristics of COPD patients with a failed weaning test and those with a successful test. Our hypothesis is that patients with a failed weaning test will have more sleep disturbances in the period of 72 hours before the weaning test.

开始日期2025-01-01

申办/合作机构

Centre Hospitalier Universitaire de Grenoble

NCT06642896 / Not yet recruitingN/AIIT

Quantitative Pupillometry in Brain Injury Children : Variation After Osmotherapy

Intracranial hypertension (ICH) is a common and serious complication in children admitted to pediatric intensive care units. It is primarily caused by traumatic brain injury but can also result from brain malformations, brain tumors, or neuro-meningeal infections. Rapid identification of ICH in acute settings is crucial to ensure prompt management and mitigate potential consequences, such as severe neurological sequelae or death.
The assessment of the pupillary light reflex is one of the key clinical parameters used to identify ICH in children with neurological injuries. This clinical sign is correlated with neurological prognosis. During an episode of ICH, regardless of the underlying cause, the oculomotor nerve becomes compressed between the midbrain and the temporal lobe, leading to anisocoria (unequal pupil sizes) and loss of pupillary reactivity. Other factors, such as episodes of ischemia or hypoperfusion in the midbrain, can also contribute to decreased pupillary reactivity.

开始日期2024-12-01

申办/合作机构

Centre Hospitalier Universitaire de Grenoble

NCT06611007 / Not yet recruiting临床1/2期IIT

Evaluation of the Safety of LipiodolⓇ Embolization in Symptomatic Digital Osteoarthritis Refractory to Conventional Treatment: a Pilot Study of 15 Patients

The goal of this clinical trial is to evaluate the safety of arterial embolization using Lipiodol® in patients with symptomatic hand osteoarthritis refractory to conventional treatment. It will also learn about the efficacy of arterial embolization with Lipiodol® in reducing pain and improving hand function.
The main questions it aims to answer are:
* What are the side effects and complications associated with the Lipiodol® arterial embolization procedure?
* Does arterial embolization reduce pain intensity and improve hand function?
Researchers will evaluate patients over a 6-month period to assess the safety of Lipiodol® embolization and its impact on joint pain, swelling, and functional capacity. Participants will:
* Undergo arterial embolization with Lipiodol®
* Participate in regular follow-ups to monitor pain relief, hand function, and any side effects
* Have imaging studies to assess changes in joint vascularisation and damage

开始日期2024-11-15

申办/合作机构

Centre Hospitalier Universitaire de Grenoble

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2024-10-01·European urology oncology

Performance of a Region of Interest–based Algorithm in Diagnosing International Society of Urological Pathology Grade Group ≥2 Prostate Cancer on the MRI-FIRST Database—CAD-FIRST Study

Article

作者: Mozer, Pierre ; Branchu, Arthur ; Mottet, Nicolas ; Aziza, Richard ; Mège-Lechevallier, Florence ; Barry Delongchamps, Nicolas ; Colombel, Marc ; Bladou, Franck ; Rabilloud, Muriel ; Brunelle, Serge ; Moldovan, Paul C ; Renard-Penna, Raphaele ; Descotes, Jean-Luc ; Grange, Rémi ; Jaouen, Tristan ; Portalez, Daniel ; Arfi, Nicolas ; Eschwege, Pascal ; Rouvière, Olivier ; Lefèvre, Frédéric ; Decaussin-Petrucci, Myriam ; Melodelima-Gonindard, Christelle ; Puech, Philippe ; Ruffion, Alain ; Souchon, Rémi ; Colin, Pierre ; Guillaume, Bénédicte ; Cornud, François ; Debeer, Sabine ; Potiron, Eric ; Baseilhac, Pierre ; Mansuy, Adeline ; Marcelin, Clément ; Grenier, Nicolas ; Walz, Jochen ; Couchoux, Thibaut ; Correas, Jean-Michel ; Roumiguié, Matthieu ; Fiard, Gaelle ; Lang, Hervé ; Villers, Arnauld ; Tricard, Thibault ; Crouzet, Sébastien ; Timsit, Marc-Olivier ; Badet, Lionel ; Malavaud, Bernard ; Bratan, Flavie ; Roy, Catherine

BACKGROUND AND OBJECTIVE:

Prostate multiparametric magnetic resonance imaging (MRI) shows high sensitivity for International Society of Urological Pathology grade group (GG) ≥2 cancers. Many artificial intelligence algorithms have shown promising results in diagnosing clinically significant prostate cancer on MRI. To assess a region-of-interest-based machine-learning algorithm aimed at characterising GG ≥2 prostate cancer on multiparametric MRI.

METHODS:

The lesions targeted at biopsy in the MRI-FIRST dataset were retrospectively delineated and assessed using a previously developed algorithm. The Prostate Imaging-Reporting and Data System version 2 (PI-RADSv2) score assigned prospectively before biopsy and the algorithm score calculated retrospectively in the regions of interest were compared for diagnosing GG ≥2 cancer, using the areas under the curve (AUCs), and sensitivities and specificities calculated with predefined thresholds (PIRADSv2 scores ≥3 and ≥4; algorithm scores yielding 90% sensitivity in the training database). Ten predefined biopsy strategies were assessed retrospectively.

KEY FINDINGS AND LIMITATIONS:

After excluding 19 patients, we analysed 232 patients imaged on 16 different scanners; 85 had GG ≥2 cancer at biopsy. At patient level, AUCs of the algorithm and PI-RADSv2 were 77% (95% confidence interval [CI]: 70-82) and 80% (CI: 74-85; p = 0.36), respectively. The algorithm's sensitivity and specificity were 86% (CI: 76-93) and 65% (CI: 54-73), respectively. PI-RADSv2 sensitivities and specificities were 95% (CI: 89-100) and 38% (CI: 26-47), and 89% (CI: 79-96) and 47% (CI: 35-57) for thresholds of ≥3 and ≥4, respectively. Using the PI-RADSv2 score to trigger a biopsy would have avoided 26-34% of biopsies while missing 5-11% of GG ≥2 cancers. Combining prostate-specific antigen density, the PI-RADSv2 and algorithm's scores would have avoided 44-47% of biopsies while missing 6-9% of GG ≥2 cancers. Limitations include the retrospective nature of the study and a lack of PI-RADS version 2.1 assessment.

CONCLUSIONS AND CLINICAL IMPLICATIONS:

The algorithm provided robust results in the multicentre multiscanner MRI-FIRST database and could help select patients for biopsy.

PATIENT SUMMARY:

An artificial intelligence-based algorithm aimed at diagnosing aggressive cancers on prostate magnetic resonance imaging showed results similar to expert human assessment in a prospectively acquired multicentre test database.

2024-08-01·European journal of trauma and emergency surgery : official publication of the European Trauma Society

Prediction of neurocritical care intensity through automated infrared pupillometry and transcranial doppler in blunt traumatic brain injury: the NOPE study

Article

作者: Gauss, Tobias ; Sourd, Dimitri ; Bouzat, Pierre ; Privitera, Claudio ; Teixeira, Thomas Luz ; Adolle, Anais ; Taccone, Fabio Silvio ; Payen, Jean-François ; Bosson, Jean-Luc ; Banco, Pierluigi

Abstract:

Purpose:

This pilot study aimed to determine the capacity of automated infrared pupillometry (AIP) alone and in combination with transcranial doppler (TCD) on admission to rule out need for intense neuroAQ2 critical care (INCC) in severe traumatic brain injury (TBI).

Methods:

In this observational pilot study clinicians performed AIP and TCD measurements on admission in blunt TBI patients with a Glasgow Coma Score (GCS) < 9 and/or motor score < 6. A Neurological Pupil index (NPi) < 3, Pulsatility Index (PI) > 1,4 or diastolic blood flow velocity (dV) of < 20 cm/s were used to rule out the need for INCC (exceeding the tier 0 Seattle Consensus Conference). The primary outcome was the negative likelihood ratio (nLR) of NPi < 3 alone or in combination with TCD to detect need for INCC.

Results:

A total of 69 TBI patients were included from May 2019 to September 2020. Of those, 52/69 (75%) median age was 45 [28–67], median prehospital GCS of 7 [5–8], median Injury Severity Scale of 13.0 [6.5–25.5], median Marshall Score of 4 [3–5], the median Glasgow Outcome Scale at discharge was 3 [1–5]. NPi < 3 was an independent predictor of INCC. NPi demonstrated a nLR of 0,6 (95%CI 0.4–0.9; AUROC, 0.65, 95% CI 0.51–0.79), a combination of NPi and TCD showed a nLR of 0.6 (95% CI 0.4–1.0; AUROC 0.67 95% CI 0.52–0.83) to predict INCC.

Conclusion:

This pilot study suggests a possible useful contribution of NPi to determine the need for INCC in severe blunt TBI patients on admission.

2024-08-01·ANNALS OF NEUROLOGY

Disentangling Bradykinesia and Rigidity in Parkinson's Disease: Evidence from Short‐ and Long‐Term Subthalamic Nucleus Deep Brain Stimulation

Article

作者: Chabardes, Stephan ; Meoni, Sara ; Fraix, Valerie ; Bove, Francesco ; Zampogna, Alessandro ; Suppa, Antonio ; Castrioto, Anna ; Cavallieri, Francesco ; Moro, Elena ; Pelissier, Pierre ; Schmitt, Emmanuelle

Objective:

Bradykinesia and rigidity are considered closely related motor signs in Parkinson disease (PD), but recent neurophysiological findings suggest distinct pathophysiological mechanisms. This study aims to examine and compare longitudinal changes in bradykinesia and rigidity in PD patients treated with bilateral subthalamic nucleus deep brain stimulation (STN‐DBS).

Methods:

In this retrospective cohort study, the clinical progression of appendicular and axial bradykinesia and rigidity was assessed up to 15 years after STN‐DBS in the best treatment conditions (ON medication and ON stimulation). The severity of bradykinesia and rigidity was examined using ad hoc composite scores from specific subitems of the Unified Parkinson's Disease Rating Scale motor part (UPDRS‐III). Short‐ and long‐term predictors of bradykinesia and rigidity were analyzed through linear regression analysis, considering various preoperative demographic and clinical data, including disease duration and severity, phenotype, motor and cognitive scores (eg, frontal score), and medication.

Results:

A total of 301 patients were examined before and 1 year after surgery. Among them, 101 and 56 individuals were also evaluated at 10‐year and 15‐year follow‐ups, respectively. Bradykinesia significantly worsened after surgery, especially in appendicular segments (p < 0.001). Conversely, rigidity showed sustained benefit, with unchanged clinical scores compared to preoperative assessment (p > 0.05). Preoperative motor disability (eg, composite scores from the UPDRS‐III) predicted short‐ and long‐term outcomes for both bradykinesia and rigidity (p < 0.01). Executive dysfunction was specifically linked to bradykinesia but not to rigidity (p < 0.05).

Interpretation:

Bradykinesia and rigidity show long‐term divergent progression in PD following STN‐DBS and are associated with independent clinical factors, supporting the hypothesis of partially distinct pathophysiology. ANN NEUROL 2024;96:234–246

项与 Centre Hospitalier Universitaire de Grenoble 相关的新闻（医药）

2023-10-30

·BioSpace

Endo Tools Therapeutics announces recruitment of first patient in ESTIME clinical trial

Belgian medtech company sponsors comparative trial in France, on use of endomina® in endoscopic gastroplasty procedures to treat patients with type II diabetes and class I obesity Important step in technique gaining reimbursement approval from France’s national health authority Gosselies, Belgium, October 25, 2023 – Endo Tools Therapeutics (ETT), a company that develops and markets advanced endoscopic medical devices in Europe and the US, today announces the enrolment of the first patient in its ESTIME clinical trial. The trial focuses on ETT’s endomina® platform, which enables endoscopists to perform a volume reduction of the stomach using a minimally invasive procedure performed through the patient’s mouth. The aim of this prospective, multicenter randomized controlled trial is to demonstrate that an endoscopic gastroplasty performed with the endomina triangulation platform and the TAPES suturing unit can help type II diabetes patients enter remission through weight loss or reduce their use of antidiabetic medications. The trial will also evaluate whether the procedure improves patients’ quality of life. It will comprise 11 trial sites in France and 205 study participants. The procedure has the potential to transform the treatment options available to patients with type II diabetes and class I obesity. The first patient was recruited onto the trial, led by endocrinologist Professor Anne-Laure Borel, on September 29, 2023, at Grenoble University Hospital. Following approval by France’s national health authority (HAS - Haute Autorité de Santé) in June 2022, the procedure will be subsidized by the Assurance Maladie insurance fund at a select group of healthcare establishments in France, as part of its Forfait Innovation special funding program. This is the first study of its kind to be funded by a Forfait Innovation. “This clinical trial provides a unique opportunity for patients with type II diabetes and class I obesity to receive new treatments. It is essential that we evaluate innovative weight-loss treatment solutions, so that we can reduce the effects of type II diabetes, a major comorbidity of obesity. If this trial shows the treatment to be effective, it could be a very interesting option for patients,” said Prof. Borel. “We are delighted that the minister for health has granted early support and special funding for the ESTIME trial, allowing patients to be treated within this study. The data from the trial will be critical in gaining reimbursement for this technique, which will add a new treatment option for patients with type II diabetes and obesity,” said Alexandre Chau, CEO of Endo Tools Therapeutics. According to the International Diabetes Federation (IDF), around 537 million adults around the world are living with diabetes. In 2021, the condition caused 6.7 million deaths worldwide. Type II diabetes is the most common type of diabetes and is closely linked to obesity; of the three million people in France with type II diabetes, 41% (1.2 million people) are obese. This figure is estimated to be 23 million in Europe and 18 million in the US. The clinical benefits of Endomina on obesity have already been proven in routine clinical practice. These findings support the results from earlier clinical trials, with an expected average excess weight loss of over 45% at 12 months. About Endo Tools Therapeutics Located in Gosselies, Belgium, Endo Tools Therapeutics S.A. (ETT) offers a portfolio of advanced, incisionless and minimally invasive endoscopic medical devices. The company’s mission is to develop solutions that expand the range of gastrointestinal procedures that can be performed using standard gastroscopes, such as bariatric surgery, Endoscopic Full-Thickness Resection (EFTR) and GastroEsophageal Reflux (GER). By developing minimally invasive treatment solutions, ETT aims to reduce the number of complications and the length of hospital stay for patients, and in doing so increase their comfort. The initial results from bariatric procedures performed using ETT’s soft tissue approximation devices were published in the following journals: GIE in 2017, Endoscopy in 2018, Gut in 2020 and EIO in 2022. To date, over 900 procedures have been performed using Endo Tools Therapeutics’ devices across Europe, the US and the Middle East. In Europe, the devices are approved for use in endoscopic gastroplasty procedures for the treatment of obesity, while in the US they are cleared for tissue apposition. Press and analyst contacts Andrew Lloyd and Associates Juliette Schmitt / Céline Gonzalez Tel.: +33 (0)1 56 54 07 00 @ALA_Group

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