[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100599290":3},{"organization":4,"armGroups":7,"interventions":36,"overallOfficials":50,"centralContacts":55,"locations":62,"responsibleParty":75,"collaborators":41,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":80,"sex":85,"minAge":86,"maxAge":41,"enrollmentInfo":87,"targetDuration":41,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":97,"overallStatus":103,"whyStopped":41,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Evangelismos Hospital","OTHER",[8,16,20,24,28,32],{"label":9,"type":10,"description":11,"interventionNames":12},"Sequence A: VC → PC → PRVC","EXPERIMENTAL","Participants receive mechanical ventilation in the following sequence: Volume Control (VC), followed by Pressure Control (PC), then Pressure-Regulated Volume Control (PRVC). Pupillometry is performed after each mode following a 15-minute stabilization period.",[13,14,15],"Other: Volume Control Ventilation","Other: Pressure Control Ventilation","Other: Pressure-Regulated Volume Control (PRVC)",{"label":17,"type":6,"description":18,"interventionNames":19},"Sequence B: VC → PRVC → PC","Participants receive mechanical ventilation in the following sequence: Volume Control (VC), followed by Pressure-Regulated Volume Control (PRVC), then Pressure Control (PC). Pupillometry is performed after each mode following a 15-minute stabilization period.",[13,14,15],{"label":21,"type":6,"description":22,"interventionNames":23},"Sequence C: PC → VC → PRVC","Participants receive mechanical ventilation in the following sequence: Pressure Control (PC), followed by Volume Control (VC), then Pressure-Regulated Volume Control (PRVC). Pupillometry is performed after each mode following a 15-minute stabilization period.",[13,14,15],{"label":25,"type":6,"description":26,"interventionNames":27},"Sequence D: PC → PRVC → VC","Participants receive mechanical ventilation in the following sequence: Pressure Control (PC), followed by Pressure-Regulated Volume Control (PRVC), then Volume Control (VC). Pupillometry is performed after each mode following a 15-minute stabilization period.",[13,14,15],{"label":29,"type":6,"description":30,"interventionNames":31},"Sequence E: PRVC → VC → PC","Participants receive mechanical ventilation in the following sequence: Pressure-Regulated Volume Control (PRVC), followed by Volume Control (VC), then Pressure Control (PC). Pupillometry is performed after each mode following a 15-minute stabilization period.",[13,14,15],{"label":33,"type":6,"description":34,"interventionNames":35},"Sequence F: PRVC → PC → VC","Participants receive mechanical ventilation in the following sequence: Pressure-Regulated Volume Control (PRVC), followed by Pressure Control (PC), then Volume Control (VC). Pupillometry is performed after each mode following a 15-minute stabilization period.",[13,14,15],[37,42,46],{"type":6,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"Volume Control Ventilation","Standard mode of mechanical ventilation delivering a preset tidal volume. Commonly used in ICU patients requiring controlled ventilation.",[9,17,21,25,29,33],null,{"type":6,"name":43,"description":44,"armGroupLabels":45,"otherNames":41},"Pressure Control Ventilation","Pressure-targeted ventilation mode that delivers breaths at a fixed pressure. Commonly used in critically ill patients.",[9,17,21,25,29,33],{"type":6,"name":47,"description":48,"armGroupLabels":49,"otherNames":41},"Pressure-Regulated Volume Control (PRVC)","Hybrid ventilation mode that automatically adjusts inspiratory pressure to achieve a preset tidal volume.",[9,17,21,25,29,33],[51],{"name":52,"affiliation":53,"role":54},"Charikleia S Vrettou, MD, PhD","!st ICU dpt., Evangelismos General Hospital","PRINCIPAL_INVESTIGATOR",[56],{"name":57,"role":58,"phone":59,"phoneExt":60,"email":61},"Charikleia S. Vrettou, MD, PhD","CONTACT","+302132105621","5621","vrettou@hotmail.com",[63],{"facility":64,"status":41,"city":65,"state":41,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":41},"!st ICU dpt., Evangelismos Hospital","Athens","10676","Greece","GR",{"type":70,"coordinates":71},"Point",[72,73],23.72784,37.98376,{"lat":73,"lon":72},{"type":54,"investigatorFullName":76,"investigatorTitle":77,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"Charikleia Vrettou","Principal Investigator","100599290","effect-of-ventilation-mode-in-the-pupillary-light-reflex-a-crossover-study-100599290",false,"NCT07082569","Effect of Ventilation Mode in the Pupillary Light Reflex: A Crossover Study","EYE-BREATH","Inclusion Criteria\n\n* Adult patients (≥18 years old)\n* Receiving positive-pressure mechanical ventilation\n* Under light or no sedation (e.g., RASS score between -2 and 0)\n* Clinically assessed by the treating physician as not yet ready for weaning from mechanical ventilation\n* Hemodynamically stable at the time of measurement\n* Presence of an arterial catheter in place for blood gas analysis\n* Written informed consent obtained from the patient's legal representative Exclusion Criteria\n* Acute or chronic neurological disease affecting brainstem function or pupillary responses\n* Dyssynchrony with the ventilator or need for high ventilatory support adjustments\n* Facial injuries, edema, or conditions precluding accurate pupillometry\n* Use of neuromuscular blocking agents within the prior 6 hours\n* Severe metabolic or acid-base imbalances that may influence autonomic regulation\n* Concurrent participation in another interventional study that could affect neurological or autonomic outcomes","ALL","18 Years",{"count":88,"type":89},36,"ESTIMATED","INTERVENTIONAL",[92],"NA","The goal of this clinical trial is to explore whether different modes of mechanical ventilation affect pupillary constriction velocities in critically ill patients without brain injury. The study aims to determine whether the type of mechanical ventilation (volume control, pressure control, or pressure-regulated volume control) influences the maximum and mean constriction velocity measured by automated pupillometry. The trial also investigates whether changes in pupil dynamics reflect subtle alterations in brainstem-autonomic interaction induced by ventilation mode.\n\nThe comparison involves volume control, pressure control, and pressure-regulated volume control in a randomized crossover design to assess whether ventilation mode has a measurable effect on pupil response.\n\nEligible participants will be intubated ICU patients receiving assist control ventilation who are not yet ready for spontaneous breathing trials. Serial pupillometry measurements will be conducted while participants are ventilated with each mode for at least 15 minutes. Sedation and lighting conditions will remain consistent throughout the protocol. Participants with acute or chronic neurologic conditions or ventilator dyssynchrony will be excluded.",[95,96],"Mechanical Ventilation","Critical Illness",[98,99,100,101,102],"Critical illness","Mechanical ventilation","Pupillary light reflex","Automated pupillometry","Neurological Pupil Index","NOT_YET_RECRUITING","2025-07-23",{"date":106,"type":107},"2025-07-24","ACTUAL",{"date":109,"type":89},"2025-07-15",{"date":111,"type":89},"2026-09-30",{"name":5,"class":6},1]