[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University Hospital Ulm\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":51},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":5},"100644051","oral-protect-i-oral-asepsis-preventing-transmission-during-intubation-100644051",false,"NCT07669064","ORAL-PROTECT I: Oral Asepsis Preventing Transmission During Intubation","ORAL-PROTECT I: Oral Asepsis for Preoperative Reduction Of Tracheal Bacterial Establishment, Colonization, and Transmission","ORAL-PROTECT I","Inclusion Criteria:\n\n* Age ≥ 60 years\n* Elective surgery under general anesthesia with endotracheal intubation\n* Expected duration of surgery ≥ 2 hours\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Systemic antibiotic therapy within 7 days before surgery\n* Planned postoperative systemic antibiotic therapy\n* Known hypersensitivity or allergy to chlorhexidine\n* Pneumonia or clinically relevant respiratory infection within 7 days before surgery\n* Inability to perform the study intervention as intended\n* Preoperative oral hygiene on the day of surgery, less than four hours prior to induction of the general anesthesia","ALL","60 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"NA","Postoperative respiratory complications, such as bacterial pneumonia, are common and serious problems after general anesthesia. They can lead to longer hospital stays, more complications, and increased mortality. One possible cause is that bacteria from the mouth and throat enter the lower airways during tracheal intubation.\n\nThe mouth and throat naturally contain many bacteria, including potentially harmful microorganisms. During general anesthesia, coughing and swallowing reflexes are reduced or absent. When a tracheal tube is inserted, secretions from the mouth and throat may be carried into the trachea. The tube may also support the movement of contaminated fluid into the lower airways.\n\nORAL-PROTECT I is a prospective, randomized, controlled study. It investigates whether simple oral hygiene before surgery can reduce the transfer of bacteria into the trachea during airway management under general anesthesia.\n\nThe study includes patients aged 60 years or older undergoing elective surgery under general anesthesia with tracheal intubation. Participants are randomly assigned to an intervention group or a control group. The intervention group performs oral hygiene immediately before anesthesia. This includes brushing the teeth and tongue for about 3 minutes, followed by rinsing and gargling for about 1 minute with a chlorhexidine antiseptic solution. The control group receives standard care without additional oral hygiene.\n\nOral, pharyngeal, and tracheal swabs will be collected at predefined time points. The primary outcome is based on the perioperative tracheal bacterial load, sampled every 30 minutes and assessed at two hours after induction of anesthesia. The co-primary outcome is based on the oral bacterial load immediately before endotracheal intubation.\n\nSecondary outcomes include changes in oral and tracheal bacterial load over time and identification of the microorganisms detected. The study aims to clarify early bacterial transfer during airway management and to evaluate whether a simple preoperative oral hygiene measure can reduce this process.",[27,28,29],"Bacterial Transmission","Intubation Intratracheal","Chlorhexidine",[31,32,33,34,35,36,37,38],"anesthesia, general","oral hygiene","bacterial load","oropharyngeal","respiratory mucosa","chlorhexidine","tracheal intubation","mouth rinsing","NOT_YET_RECRUITING","2026-06-21",{"date":42,"type":43},"2026-06-25","ACTUAL",{"date":45,"type":21},"2026-06-20",{"date":47,"type":21},"2027-05-01",{"name":49,"class":50},"University Hospital Ulm","OTHER",""]