[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100547468":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":24,"locations":30,"responsibleParty":46,"collaborators":18,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":18,"eligibilityCriteria":56,"healthyVolunteers":57,"sex":58,"minAge":18,"maxAge":18,"enrollmentInfo":59,"targetDuration":18,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":69,"overallStatus":32,"whyStopped":18,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Hospital Felicio Rocho","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Maneuver group","EXPERIMENTAL","Patients in the experimental group will receive detailed training and guidance on pressure equalization techniques and barotrauma prevention measures before undergoing treatment in a hyperbaric chamber. The specific maneuvers to be implemented are outlined below:\n\nToynbee Maneuver: This maneuver involves swallowing with both the mouth and nose closed, thereby reducing the pressure in the nasopharynx and tympanic cavity.\n\nUnilateral Passive Valsalva Maneuver: This technique involves occluding one external nasal valve while performing a Valsalva maneuver on the opposite side.\n\nThese maneuvers will be performed continuously during the compression phase of the hyperbaric chamber, every 30 minutes after reaching the desired pressurization level, and continuously during the decompression phase.",[13],"Behavioral: Maneuver group",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard treatment","NO_INTERVENTION","Patients will receive the standard instructions for the hyperbaric chamber without specific guidance on performing equalization maneuvers.",null,[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":18},"BEHAVIORAL","These maneuvers for Eustachian tube opening will be performed continuously during the compression phase of the hyperbaric chamber, every 30 minutes after reaching the desired pressurization level, and continuously during the decompression phase.",[9],[25],{"name":26,"role":27,"phone":28,"phoneExt":18,"email":29},"Alan Rodrigues de Almeida Paiva, MD","CONTACT","+55 31 996869586","alanrodriguesmd@gmail.com",[31],{"facility":5,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"RECRUITING","Belo Horizonte","Minas Gerais","30110-934","Brazil","BR",{"type":39,"coordinates":40},"Point",[41,42],-43.93778,-19.92083,{"lat":42,"lon":41},[45],{"name":26,"role":27,"phone":28,"phoneExt":18,"email":29},{"type":47,"investigatorFullName":48,"investigatorTitle":49,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Alan Rodrigues de Almeida Paiva","Principal investigator","100547468","effectiveness-of-sequential-eustachian-tube-maneuvers-in-hyperbaric-oxygen-conditions-100547468",false,"NCT06408363","Effectiveness of Sequential Eustachian Tube Maneuvers in Hyperbaric Oxygen Conditions","Effectiveness of Sequential Eustachian Tube Maneuvers in Hyperbaric Oxygen Conditions: A Randomized Controlled Study","Inclusion Criteria:\n\n* Patient undergoing the first hyperbaric session.\n* Understanding and properly carrying out equalization maneuvers\n\nExclusion Criteria:\n\n* Patients who did not understand the equalization maneuvers\n* Patients with specific contraindications to hyperbaric therapy\n* Patients with acute middle ear or tympanic membrane disease",true,"ALL",{"count":60,"type":61},100,"ESTIMATED","INTERVENTIONAL",[64],"NA","Middle ear barotrauma represents the predominant complication associated with hyperbaric oxygen therapy, manifesting symptoms ranging from otalgia to tympanic membrane perforation. Several pressurization protocols have been proposed to reduce the incidence of this trauma, but barotrauma is still the main cause of poor adherence to hyperbaric therapy. Therefore, this study aims to evaluate the effectiveness of serial tubal opening maneuvers to prevent barotrauma in patients undergoing treatment in a hyperbaric chamber.",[67,68],"Barotrauma;Ear","Tympanum; Perforation",[70,71,72,73],"Barotrauma","Tympanic Membrane Perforation","Eustachian Tube","Hyperbaric Oxygenation","2026-02-05",{"date":76,"type":77},"2026-02-09","ACTUAL",{"date":79,"type":77},"2023-05-01",{"date":81,"type":61},"2026-12-01",{"name":5,"class":6},1]