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NCT07409727
Background Mechanical ventilation is an essential medical intervention in the context of critical illness. However, the intervention is associated with a risk of significant, potentially preventable complications. Among these are ventilator-associated pneumonia, sepsis, acute respiratory distress syndrome, atelectasis, and pulmonary edema. Ventilator-associated complications commonly increase morbidity and mortality. They may also prolong the duration of mechanical ventilation and the length of stay in the hospital or the intensive care unit, with increased health care costs; so safe, effective therapeutic and preventative strategies are essential to attenuate poor outcomes from ventilator-associated events. Secretion retention and ineffective cough play a significant role in failed extubation and weaning from ventilator; the presence of the artificial airway, poor humidification of inspired gases, and immobility are the major causes of pulmonary secretion retention in this population. Accumulated secretion in the airways, if extensive, starts a self-sustaining cycle of ventilation/perfusion mismatch, gas-exchange impairment, increased work of breathing. For decades N-acetyl-L-cysteine (NAC) has been used for its mucolytic properties orally in different respiratory diseases like chronic obstructive pulmonary disease (COPD), idiopathic pulmonary fibrosis (IPF) and cystic fibrosis (CF); but its effects are not known if given by nebulization through endotracheal tube (ETT), studies to date have provided inconclusive results. Despite this uncertainty, mucoactive agents are still used in adult ICUs. NAC is usually administered orally, with several formulations and dosage forms available for both short- and long-term treatment of respiratory diseases. The inhalation route might also be considered a practical option, with recent interest, as the therapeutic drug acts directly on the bronchial mucosa, promotes continuous local retention of the drug, prolongs anti-inflammatory effects, and avoids the liver first-pass effect, which can help quickly improve airway inflammation. Contrary to other mucoactive drugs, NAC has been found to exhibit antioxidant, anti-inflammatory, antibacterial, and antibiofilm activities. In the respiratory infection field, the available data indicate that NAC was associated with inhibition of oxidative stress and reduced the inflammatory factors in community acquired pneumonia, antibiofilm activity specially in pseudomonas aeruginosa infection in pre-clinical and clinical reports and has good antibacterial properties and suggested to interfere with biofilm formation and disruption. NAC has shown improvement in the respiratory index (PaO₂/FiO₂), with lower rates of mechanical ventilation in COVID-19. When studied in mechanically ventilated patients with acute respiratory distress syndrome (ARDS), which is associated with oxidative stress, increased levels of glutathione, and inflammation, NAC demonstrated improvements in positive end-expiratory pressure (PEEP) and PaO₂/FiO₂. N-Acetylcysteine contributed to delaying ventilator-associated pneumonia (VAP) in mechanically ventilated patients when administered orally as a preventive medication. It was also effective in attenuating the decline in forced vital capacity (FVC) in mild to moderate idiopathic pulmonary fibrosis (IPF), and it showed a lower rate of postoperative pulmonary complications when given pre-operatively in orthotopic liver transplantation. Since NAC is relatively low-cost, readily available, and has a favorable side effect profile, it is important to properly assess the clinical benefits of nebulized NAC as an adjunct to standard medical treatments in mechanically ventilated patients. Aim of the study This study will assess the role of preventive N-acetylcysteine inhalation on incidence and time to develop VAP in critically ill mechanically ventilated patients. Objectives * 1\) Assessment of N-acetylcysteine inhalation efficacy in mechanically ventilated patients through monitoring the following parameters: time to develop ventilator-associated pneumonia (VAP), incidence of VAP, PaO₂/FiO₂, pH, oxygen saturation (SaO₂), peak inspiratory pressure (PIP), positive end-expiratory pressure (PEEP), frequency of endotracheal tube (ETT) suction and tube exchange, and infection parameters (total leukocyte count, body temperature). In addition, hospital mortality, duration of mechanical ventilation (MV), ventilator-free days, and the length of hospital and ICU stay * 2\) Assessment of the safety of N-acetylcysteine inhalation in mechanically ventilated patients by monitoring the incidence of new-onset bronchospasm
NCT01745796
Pseudomonas aeruginosa is the main pathogen of nosocomial respiratory infections. Its increasing resistance to antibiotics requires the development of new strategies for prevention and control, demanding a better understanding of the modes of transmission and evolutionary dynamics of this bacteria. In patients under invasive mechanical ventilation, the main mode of contamination by Pseudomonas remains debated, with 3 modes of contamination (endogenous, crossed transmission between patients, or environmental origin) of varying importance, mainly depending on the endemic situation of the place of study. The emergence of new genotyping technologies (DiversiLab) can now facilitate studies of molecular epidemiology. Thanks to the multidisciplinary collaboration and innovative techniques, the investigators wish to study the impact of the mode of contamination on the outcome of ICU patients, intubated and ventilated for more than 72 hours.
NCT02265406
Ventilation-associated pneumonia (VAP) is the main site of healthcare-associated infections in the brain injured patients, with an incidence rate of 22% to 58%. VAP increases morbi-mortality, length of stay in intensive care and overall management costs. The prevention of ICU nosocomial infections depends on several measures : orotracheal intubation route, maintaining tube cuff pressure between 25 and 30 cm of water (H2O), maintaining a semi-seated position \>= 30°, nasal and oropharyngeal care at regular intervals, striving to avoid unscheduled extubation, and use of a written sedation-analgesia algorithm allowing for early weaning from ventilation. Two randomized study show that administration of antibiotic therapy after intubation reduces the risk of early VAP incidence. However, in clinical practice, its administration solely purposes of limiting VAP occurence is not presently recommended. Indeed, to date no placebo blind controlled study was been realized and the fear of development of bacterial resistance remains stronger than the efficiency of this prevention measure. This aim of the present study is to show by a placebo randomized study that 2g of Ceftriaxone within 8 hours post-intubation after a brain injury decrease the risk of occurence an early VAP. Ancillary study An ancillary study is performed in 2 centres which routinely practice rectal swabs at admission and discharge of ICU, to survey intestinal flora (CHU of Angers and CHU of Rennes). The goal of this study is to compare the incidence of acquired cephalosporin resistant gram negative bacteria at the discharge of ICU between the 2 groups of patients, receiving or not ceftriaxone.