[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637146":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":48,"locations":58,"responsibleParty":114,"collaborators":118,"id":125,"slug":126,"hasResults":127,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":131,"eligibilityCriteria":132,"healthyVolunteers":127,"sex":133,"minAge":134,"maxAge":26,"enrollmentInfo":135,"targetDuration":26,"studyType":138,"phases":139,"briefSummary":141,"conditions":142,"keywords":144,"overallStatus":153,"whyStopped":26,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":163},{"fullName":5,"class":6},"Federal University of Pelotas","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Videolaryngoscope 3D with artificial intelligence (VL-AI)","EXPERIMENTAL","Patients in the intervention group will receive the usual care for orotracheal intubation, differing only in the use of VLP-IA for opening and visualizing the upper airways.",[13],"Device: Orotracheal intubation using a 3D videolaryngoscope integrated with artificial intelligence (VL-IA).",{"label":15,"type":16,"description":17,"interventionNames":18},"Commercially available gold-standard videolaryngoscope (VL-C)","ACTIVE_COMPARATOR","Patients in the comparator group will receive standard care for orotracheal intubation, using the gold-standard VLP-C for airway opening and visualization of the upper airways.",[19],"Device: Commercially available gold-standard videolaryngoscope (VL-C)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Orotracheal intubation using a 3D videolaryngoscope integrated with artificial intelligence (VL-IA).","The videolaryngoscope (VL) incorporates a microcamera at the tip of the blade, enabling real-time visualization of anatomical structures via a monitor. The VL to be used in the intervention was manufactured through additive manufacturing using polylactic acid (PLA) and polyethylene terephthalate glycol (PETG). It was validated in high-fidelity simulations for mechanical strength and usability and is patented under number BR 10 2020 026194 with the Brazilian National Institute of Industrial Property (INPI).\n\nThe VL is currently being enhanced through the integration of artificial intelligence (AI) using computer vision techniques based on Machine Learning and Deep Learning, including convolutional neural networks capable of automatically recognizing upper airway anatomical structures from previously trained image datasets. The embedded system will provide real-time visual and audio guidance during intubation with less than one-second latency.",[9],null,{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"Scientific evidence recommends the use of VL in all cases of intubation, across various clinical scenarios, as the primary intubation technique in clinical practice. The videolaryngoscope incorporates a microcamera at the tip of the blade, allowing visualization of anatomical structures in real time via a monitor.",[15],[31,35,38,40,42,45],{"name":32,"affiliation":33,"role":34},"Camila X Dalcól, PhD","University Federal of Santa Catarina","STUDY_CHAIR",{"name":36,"affiliation":37,"role":34},"Ines M Hirdes, Specialist","University Catolic of Pelotas",{"name":39,"affiliation":33,"role":34},"Larissa O Daneluz, Master's degree",{"name":41,"affiliation":33,"role":34},"Andressa S Barboza, PhD",{"name":43,"affiliation":44,"role":34},"Marcelo C Ribeiro, Master's degree","University federal of Pelotas",{"name":46,"affiliation":47,"role":34},"Tiago T Primo, PhD","University Federal of Pelotas",[49,54],{"name":50,"role":51,"phone":52,"phoneExt":26,"email":53},"Rafael G Lund, PhD","CONTACT","+55 (53) 99125-7668","rglund@ufpel.edu.br",{"name":55,"role":51,"phone":56,"phoneExt":26,"email":57},"Ana CBK de Moraes, PhD","+55 53 9176-9898","anacristinabkmoraes@gmail.com",[59,75,88,97],{"facility":60,"status":26,"city":61,"state":62,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"Husfp - Ucpel","Pelotas","Rio Grande do Sul","96020-220","Brazil","BR",{"type":67,"coordinates":68},"Point",[69,70],-52.34101,-31.76997,{"lat":70,"lon":69},[73],{"name":74,"role":51,"phone":56,"phoneExt":26,"email":57},"Ana C Moraes, PhD",{"facility":76,"status":26,"city":61,"state":62,"zip":77,"country":64,"countryCode":65,"cosmosGeoPoint":78,"geoPoint":80,"contacts":81},"Ebserh\u002FUfpel","96020-360",{"type":67,"coordinates":79},[69,70],{"lat":70,"lon":69},[82,85],{"name":50,"role":51,"phone":83,"phoneExt":26,"email":84},"+55 53 9125-7668","rafael.lund@gmail.com",{"name":43,"role":51,"phone":86,"phoneExt":26,"email":87},"+55 11 97309-0603","mcribeiro@inf.ufpel.edu.br",{"facility":89,"status":26,"city":90,"state":62,"zip":91,"country":64,"countryCode":65,"cosmosGeoPoint":92,"geoPoint":96,"contacts":26},"Ebserh\u002FFurg","Rio Grande","96200-190",{"type":67,"coordinates":93},[94,95],-52.09861,-32.035,{"lat":95,"lon":94},{"facility":98,"status":26,"city":99,"state":100,"zip":101,"country":64,"countryCode":65,"cosmosGeoPoint":102,"geoPoint":106,"contacts":107},"Ebserh\u002FUfsc","Florianópolis","South Carolina","88040-370",{"type":67,"coordinates":103},[104,105],-48.54917,-27.59667,{"lat":105,"lon":104},[108,111],{"name":32,"role":51,"phone":109,"phoneExt":26,"email":110},"+55 (43) 999856389","camila.dalcol@ufsc.br",{"name":41,"role":51,"phone":112,"phoneExt":26,"email":113},"+55 53 8448-1042","d.andressabarboza@gmail.com",{"type":115,"investigatorFullName":116,"investigatorTitle":117,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Rafael Guerra Lund","Associate Professor PhD",[119,121,123],{"name":120,"class":6},"Universidade Federal de Santa Catarina",{"name":122,"class":6},"Universidade Católica de Pelotas",{"name":124,"class":6},"Universidade Federal do Rio Grande (FURG)","100637146","ai-integrated-3d-printed-videolaryngoscope-for-orotracheal-intubation-in-critically-ill-patients-100637146",false,"NCT07592702","AI-Integrated 3D-Printed Videolaryngoscope for Orotracheal Intubation in Critically Ill Patients","Clinical Performance and Usability of an AI Integrated 3D-Printed Videolaryngoscope for Orotracheal Intubation in Critically Ill Patients","VL-AI","Inclusion Criteria:\n\nPatient:\n\n* Age ≥18 years.\n* Both sexes.\n* Clinical indication for orotracheal intubation.\n\nPhysician:\n\n* Both sexes.\n* Working in emergency or ICU settings.\n* Minimum of one year of experience in laryngoscopy and\u002For orotracheal intubation.\n\nExclusion Criteria:\n\nPatient:\n\n* Clinically unstable or with contraindications to participation in experimental research.\n* Significant airway malformations.\n* Previously intubated or with a functioning tracheostomy.\n* Pregnant.\n\nPhysicians:\n\n* On vacation or leave during the study period.\n* Orthopedic, visual, or cognitive limitations that impair participation.","ALL","18 Years",{"count":136,"type":137},120,"ESTIMATED","INTERVENTIONAL",[140],"NA","Background: Orotracheal intubation is an essential procedure in critically ill patients requiring ventilatory support, and the use of videolaryngoscopy is recommended as the gold standard in clinical practice. In recent years, the development of videolaryngoscopes through additive manufacturing has demonstrated lower production costs, and their integration with artificial intelligence (AI) has shown promising results in improving procedural success and safety.\n\nAim: To evaluate the clinical performance and usability of a videolaryngoscope developed through additive manufacturing and integrated with artificial intelligence (AI) and computer vision, compared with a commercially available gold-standard videolaryngoscope.\n\nMethods: This is a multicenter, randomized, controlled, superiority Phase I\u002FII clinical trial with a single-blind design. A total of 120 critically ill patients admitted to intensive care units at four hospitals in southern Brazil will be enrolled. Participants will be individually randomized in a 1:1 allocation ratio to parallel groups. The interventions will be performed by at least 10 physicians. All physicians will receive standardized training on device use, and procedures will be monitored by trained research staff. Data will be recorded in electronic Excel spreadsheets, and statistical analyses will be conducted using IBM SPSS Statistics. All ethical principles will be strictly observed, including obtaining informed consent from participants or their legal representatives. A Data and Safety Monitoring Committee will be established to oversee the study.\n\nConclusions: If the expected results are confirmed, patients, healthcare professionals, and healthcare institutions may benefit from the improved performance, safety, and usability of the experimental device, particularly in critical care settings and public health emergencies.",[143],"Orotracheal Intubation",[145,146,147,148,149,150,151,152],"orotracheal intubation","videolaryngoscope","artificial intelligence","computer vision","additive manufacturing","medical device","clinical performance","usability","NOT_YET_RECRUITING","2026-05-11",{"date":156,"type":157},"2026-05-18","ACTUAL",{"date":159,"type":137},"2027-03-20",{"date":161,"type":137},"2028-06",{"name":5,"class":6},4]