Clinical Research Directory

Pupillometry vs. BPS (Behavioral Pain Scale) for Analgesia Management in Inpatient Intensive Care Unit Patients on Invasive Mechanical Ventilation

Patients admitted to the intensive care unit (ICU) and receiving invasive mechanical ventilation (IMV) frequently require sedation and analgesia to ensure their comfort, prevent pain associated with invasive procedures, and minimize complications related to agitation. Appropriate analgesia management is essential to ensure patient comfort while minimizing the consequences of excessive opioid exposure, including delirium, prolonged mechanical ventilation, extended ICU stays, and the risk of post-ICU syndrome (PICS). While sedation assessment relies on validated tools such as the RASS score, pain assessment in non-communicative patients remains more complex. In practice, it relies primarily on behavioral scales such as the Behavioral Pain Scale (BPS), the only internationally validated scale that has been translated into French and is recommended for use in intensive care. However, these scales have certain limitations, particularly in deeply sedated patients or when motor expression is impaired. Thus, over the past few years, automated pupillometry has been developed to assess pain through the pupillary dilation reflex (PDR), which is an autonomic physiological response to nociception. Indeed, pupillometry allows for the quantitative measurement of the PDR induced by standardized, noninvasive nociceptive stimulation. This measurement yields the Pupillary Pain Index (PPI), which serves as an objective, reproducible, and observer-independent indicator of nociception. Measuring the PPI could enable earlier and more individualized adjustment of analgesia, leading to a reduction in painful episodes and opioid exposure. In this context, this randomized study aims to compare, in patients on mechanical ventilation with deep sedation and analgesia (RASS -4/-5), a pain monitoring strategy guided by pupillometry with standard care based on the BPS. The objective is to evaluate the impact of this strategy on the frequency of pain event detection and on complications associated with opioid use in the intensive care unit

Controlled Versus Standard Oxygen Therapy in ICU Patients With Acute Exacerbation of COPD

Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality worldwide. Acute exacerbations frequently require intensive care unit (ICU) admission. Oxygen therapy is an essential component of treatment; however, excessive oxygen administration may aggravate hypercapnia and respiratory acidosis. Current international guidelines recommend titrated oxygen therapy targeting an oxygen saturation of 88-92% in patients with acute exacerbation of COPD, but evidence supporting this strategy in critically ill ICU patients remains limited. This randomized controlled trial aims to compare a controlled oxygen therapy strategy (target oxygen saturation 88-92%) with standard oxygen therapy (oxygen saturation \>94%) in ICU patients admitted with acute exacerbation of COPD. The primary objective is to determine whether controlled oxygen therapy reduces the duration of mechanical ventilation (invasive and non-invasive). Secondary objectives include assessing the 28-day mortality, ICU length of stay, the need for invasive mechanical ventilation, and adverse events related to hyperoxia.

Management of Hypokalemia in Intensive Care Patients

Hypokalemia is a common electrolyte disorder in critically ill patients and may contribute to substantial morbidity and mortality if inadequately managed. Standardized approaches to hypokalemia management in intensive care units (ICUs) remain limited. This study aimed to develop an expert consensus-based hypokalemia treatment algorithm and to evaluate its implementation with clinical pharmacist involvement in critically ill patients. The study was conducted in the general ICU of a state hospital and consisted of two phases. In the first phase, recommendations derived from current clinical guidelines, relevant literature, and clinical practice were evaluated through a two-round expert consensus process involving specialist physicians and clinical pharmacists with ICU experience. Consensus-based recommendations were used to develop a standardized hypokalemia treatment algorithm. In the second phase, a prospective before-and-after design was used to compare routine ICU care with algorithm-guided hypokalemia management accompanied by clinical pharmacist recommendations. Prespecified outcomes included initiation and timing of potassium replacement therapy, achievement of normokalemia, time to normokalemia, recurrent hypokalemia, treatment-associated hyperkalemia, normokalemia at ICU discharge, and ICU length of stay.

Impact on Prognosis of Increased Sleep Quality Obtained by Personalized Night-time Nursing Care in Critically Ill Patients

Sleep disturbances are common among intensive care unit (ICU) patients and have been associated with difficult weaning from invasive mechanical ventilation, with an increased risk of endotracheal intubation. Other studies have reported associations between sleep disturbances and prolonged ICU length of stay or the occurrence of delirium. Among the factors contributing to sleep impairment, nighttime care interventions have been identified as a major cause. The management of sleep disorders in the ICU remains complex and often disappointing, and no pharmacological treatment is currently formally recommended. Very recently, a considerable improvement of sleep quantity (+50%) and quality (doubling of deep sleep quantity) has been reported by reorganizing nighttime nursing care according to patients' sleep cycles, using a sleep monitoring medical device. The objective of this study is to quantify the impact of a better sleep on prognosis. Sleep will be improved using sleep-guided nursing care during nighttime thanks to a real-time sleep monitor (Sleepscan°). The primary endpoint is the proportion of patients requiring invasive mechanical ventilation or who have died at day 7 after inclusion. The main secondary outcomes include the duration of ICU stay, the number of delirium free-days, the score at a discomfort scale, the score at a post-traumatic stress disorder scale at ICU discharge. Intensive care unit-related costs will be assessed. A multi-sites, prospective, randomized, open-label, superiority trial with two parallel arms will be conducted. Awake and conscious patients without continuous sedation, regardless of ventilatory support, with no indication for urgent intubation (\<12 hours) and with an expected ICU length of stay greater than 48 hours will be included. The intervention will consist of sleep-guided nighttime nursing care using the Sleepscan monitor from 7:00 p.m. to 7:00 a.m., every night until ICU discharge or day 7. Sleep-guided nursing care consist in postponing non urgent care (such as temperature measurement…) and avoiding entering the room when patients are asleep. Otherwise, when patients are awake, instructions are to go for all care, to cluster and anticipate nursing care and perform comfort care. In the control group, sleep will also be recorded using the same device but the tablet will not display the patient's sleep (or awake) status, and nighttime nursing care will be performed according to usual practice and independently of patients' sleep cycles. Based on our preliminary data and previous studies, it has been estimated that 230 patients per group will be required to detect a reduction in the proportion of patients intubated or deceased at day 7 from 20% in the control group to 10% in the intervention group. The intention-to-treat analysis population will include all randomized patients. Demonstrating an improvement in patient prognosis through enhanced sleep quality would represent a major advancement for intensive care medicine. Reducing the need for invasive mechanical ventilation may lead to shorter ICU stays, lower mortality, fewer post-ICU complications, and reduced hospital costs. Demonstrating an improvement in patient prognosis through enhanced sleep quality would represent a major advancement for intensive care medicine. Reducing the need for invasive mechanical ventilation and the incidence of delirium may lead to shorter ICU stays, lower mortality, fewer post-ICU complications, and reduced hospital costs.

Tracing Of Real-time glu13Cose Metabolism in Human Immune Cells - Intensive Care Unit

The purpose of this study is to understand how cells of the immune system use the common sugar glucose during critical illness. Investigators will intravenously infuse a non-radioactive carbon-13 glucose tracer into adult intensive care unit (ICU) participants over a few hours and collect immune cells from the blood to track uptake and usage of this glucose within these immune cells.

Arterial Blood Gas Levels, Oxygen Saturation, and Pressure Injury Risk in ICU Patients

The purpose of this study is to examine the relationship between arterial blood gas (ABG) parameters and oxygen saturation (SpO₂) levels and the risk of pressure injury development in patients hospitalized in intensive care units, and to provide a scientific contribution to the processes for assessing pressure injury risk based on the findings obtained.

CALLY Index, Frailty and SOFA-2 for Mortality Prediction in Geriatric ICU Patients

This study aims to evaluate the prognostic value of the C-reactive protein-albumin-lymphocyte (CALLY) index, Clinical Frailty Scale (CFS), and SOFA-2 score in predicting mortality among geriatric intensive care unit (ICU) patients. The primary outcome is ICU mortality. Secondary outcomes include 28-day mortality, ICU length of stay, duration of mechanical ventilation, need for renal replacement therapy, and vasopressor requirement. The study also investigates whether the combined use of these parameters improves predictive performance compared to conventional scoring systems such as APACHE II.

Virtual Reality for Recovery After Intensive Care (PICS)

The goal of this clinical trial is to learn if virtual reality (VR) helps improve thinking and memory skills in adults who have stayed in the intensive care unit (ICU). The study focuses on people who needed a breathing machine or stayed in the ICU for several days and are at risk for memory or "brain fog" issues. The main questions it aims to answer are: * Does using VR improve a participant's memory, attention, and thinking skills after an ICU stay? * Does the "immersive" feel of a VR headset work better to improve these skills than using a handheld tablet? Researchers will compare three groups to see how different types of care affect the brain: * VR-Rehab: Participants use a VR headset to play brain-training games. * Tablet-Rehab: Participants use a handheld tablet to play the same brain-training games. * Standard Care: Participants receive the usual hospital care without digital brain games. Participants will: * Play brain-training games for 12 minutes every day for up to one week while in the hospital. * Complete memory and thinking tests with a researcher at the start of the study and again after two weeks. * Answer follow-up questions about their memory and thinking skills for 6 months after leaving the hospital.

Hyperoxemia in the Intensive Care Unit(ICU)

In our study, to research the prevalence of hyperoxemia in adult patients treated in the intensive care unit (ICU) and its relationship with clinical outcomes. This single-center, observational study included 260 consecutive patients aged 18-85 years who received oxygen therapy in the ICU for respiratory failure. Hyperoxia was defined as SpO₂\>96% and PaO₂\>100 mmHg in the first 24 hours. Patients were divided into normoxic and hyperoxic groups, and demographic characteristics, comorbidities, ICU admission scores, mechanical ventilation requirements, ICU and hospital length of stay, and in-hospital mortality were compared.The mean age of the patients was 69.9±15.4 years, and 55.8% were male. According to SpO₂-PaO₂ criteria, hyperoxia was detected in 59.6% (n=155) of patients and normoxia in 40.4% (n=105). The groups were similar in terms of age, gender, BMI, and APACHE II score. The SOFA score and admission GCS were lower in the hyperoxic group, and the duration of mechanical ventilation, ICU, and hospital stays were significantly longer (p\<0.01 for all). In-hospital mortality was significantly higher in the hyperoxic group (82.5% vs. 50.4%; p\<0.001). In our study, hyperoxia developed in approximately two-thirds of the patients in the ICU, and hyperoxia was associated with increased mortality and length of stay. These results highlight the importance of avoiding hyperoxia when titrating oxygen therapy in critically ill patients.

The HIgh-fidelity Hydraulic couPling Upper-arm Cuff Assessment of Limits, Safety, and Effectiveness (HIPULSE) Trial

The purpose of this study is to compare measurements of blood pressure (BP) and fluid responsiveness between the Philips AMC and invasive radial arterial line in surgical patients.