View clinical trials related to Neurological Complication.
Filter by:The study, identified as VIX001-PACS-01, is a Phase 1, open-label, dose-escalation trial evaluating the safety, tolerability, preliminary efficacy, and dose effect of VIX001, an amniotic fluid product, in patients with Post-Acute COVID-19 Syndrome (PACS) and cognitive impairment. Conducted at the University of Miami Hospital and Clinics, the trial aims to enroll up to nine participants, or up to 18 using a 3+3 dose escalation design. Intravenous injections of VIX001 will be administered at three ascending doses (1 ml, 3 ml, or 10 ml), and participants will be assessed for safety, cognitive impairment, pain, activity, and quality of life at baseline and various timepoints. The primary objective is to evaluate the safety of VIX001, while secondary objectives include assessing its potential efficacy and patient-reported outcomes. The study duration is expected to last approximately 18 months, including enrollment, evaluation, and post-study observation periods. The findings will contribute to understanding VIX001's safety and efficacy in treating PACS-related cognitive impairment.
Mechanical ventilation (MV) is a life-saving supportive therapy and one of the most common interventions implemented in intensive care. To date, only the inspiratory phase of breathing has been extensively investigated, and new MV methods have been implemented to reduce its harmful effects. Despite this, lung injury still occurs and propagates, causing multiorgan failure and patient deaths. The expiratory phase is considered unharmful and is not monitored or assisted during MV. In animal experiments, we recently showed that the loss of diaphragmatic contraction during expiration can harm the lungs during MV. During mechanical ventilation, the expiratory phase of breathing is completely disregarded. However, in all conditions that promote lung collapse, peripheral airways gradually compress and close throughout the expiration, potentially worsening lung injury. This cyclical lung collapse and consequent air-trapping may have an impact on the Starling resistor mechanisms that regulate venous return from the brain, potentially affecting cerebral perfusion and intracranial pressure. This study will investigate the incidence and the consequences of an uncontrolled expiration and expiratory lung collapse in spontaneously breathing critically ill neurosurgical patients during mechanical ventilation. Electrical impedance tomography measurements , oesophagus and gastric pressure, electrical activity of the diaphragm and intracranial pressure will be acquired in a synchronised manner during controlled mechanical ventilation, on a daily bases during assisted mechanical ventilation.