[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639500":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":40,"responsibleParty":56,"collaborators":26,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":26,"enrollmentInfo":69,"targetDuration":26,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":42,"whyStopped":26,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Hannover Medical School","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"i-scoop Videolaryngoscope Group","EXPERIMENTAL","Participants assigned to this arm undergo airway management under spontaneous breathing and analgosedation using the i-scoop videolaryngoscope. Unlike conventional videolaryngoscopes, the i-scoop has no blade and follows the natural anatomy of the upper airway along the hard palate, comparable to laryngeal mask insertion. Two lateral optics are positioned sub-epiglottically immediately in front of the laryngeal inlet. Because the integrated tube guidance ends at the same location, the line of sight and the working axis of the tube coincide directly in front of the laryngeal inlet, allowing tube placement under continuous visual control from two perspectives.\n\nIntervention assigned: Procedure: Airway management with i-scoop videolaryngoscope under spontaneous breathing and analgosedation",[13],"Procedure: Airway management under spontaneous breathing with the i-scoop videolaryngoscope",{"label":15,"type":16,"description":17,"interventionNames":18},"C-MAC D-Blade Videolaryngoscope Group","ACTIVE_COMPARATOR","Participants assigned to this arm undergo standardized airway management under spontaneous breathing and analgosedation using the hyperangulated C-Mac D-Blade videolaryngoscope, the established institutional standard at Hannover Medical School for videolaryngoscopic airway management in patients with anticipated difficult airway. The C-Mac D-Blade has a hyperangulated blade with the camera at the blade tip; the tube is placed using a pre-shaped endotracheal tube or a pre-formed stylet. Endotracheal lidocaine is delivered via a separate applicator, since the device has no integrated tube guidance or applicator channel.\n\nIntervention assigned: Procedure: Airway management with C-Mac D-Blade videolaryngoscope under spontaneous breathing and analgosedation",[19],"Procedure: Airway management under spontaneous breathing with the C-Mac D-Blade videolaryngoscope",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Airway management under spontaneous breathing with the i-scoop videolaryngoscope","Single intervention during anesthesia induction:\n\n1. Preoxygenation via FFP2 mask, 18 L\u002Fmin O₂ until intubation.\n2. Analgosedation: remifentanil 0.3 µg\u002Fkg + propofol 0.6 mg\u002Fkg bolus, then continuous infusion; max. one additional remifentanil bolus (0.3 µg\u002Fkg); midazolam 1 mg if needed.\n3. Topical anesthesia: 150-200 mg lidocaine 1% oropharyngeally, then 20 mg lidocaine 1% endotracheally via i-scoop channel.\n4. Intubation 60-90 s later under continuous visual control via dual-optic sub-epiglottic i-scoop positioning.\n5. Tube confirmation by capnography (PUMA criteria). Training: ≥30 intubations and ≥30 lidocaine applications per operator on airway trainer before study start. Monitoring: SpO₂, ECG, NIBP, capnography, EEG. Escalation and rescue strategies available at all times.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Airway management under spontaneous breathing with the C-Mac D-Blade videolaryngoscope","Single intervention during anesthesia induction, identical to Intervention 1 except for the videolaryngoscope used:\n\n1. Preoxygenation via FFP2 mask, 18 L\u002Fmin O₂ until intubation.\n2. Analgosedation: remifentanil 0.3 µg\u002Fkg + propofol 0.6 mg\u002Fkg bolus, then continuous infusion; max. one additional remifentanil bolus (0.3 µg\u002Fkg); midazolam 1 mg if needed.\n3. Topical anesthesia: 150-200 mg lidocaine 1% oropharyngeally, then 20 mg lidocaine 1% endotracheally via separate applicator (C-Mac D-Blade has no integrated channel).\n4. Intubation 60-90 s later using C-Mac D-Blade standard technique with pre-shaped tube or stylet. (5) Tube confirmation by capnography (PUMA criteria). Training, monitoring, escalation, and rescue strategies identical to Intervention 1.",[15],[32],{"name":33,"affiliation":5,"role":34},"Konstantinos Raymondos, Professor, MD","PRINCIPAL_INVESTIGATOR",[36],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","+49 176 1 532 3317","Raymondos.Konstantinos@mh-hannover.de",[41],{"facility":5,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"RECRUITING","Hanover","Lower Saxony","30625","Germany","DE",{"type":49,"coordinates":50},"Point",[51,52],9.73322,52.37052,{"lat":52,"lon":51},[55],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},{"type":34,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Raymondos, Konstantinos Prof. Dr.","Senior Consultant, Department of Anesthesiology and Intensive Care Medicine","100639500","i-scoop-vs-c-mac-d-blade-videolaryngoscope-for-airway-management-under-spontaneous-breathing-and-analgosedation-100639500",false,"NCT07624162","I-scoop vs. C-Mac D-Blade Videolaryngoscope for Airway Management Under Spontaneous Breathing and Analgosedation","Practicability of Airway Management With the Videolaryngoscopes I-scoop and C-Mac D-Blade Under Spontaneous Breathing and Analgosedation - A Prospective, Randomized, Monocentric Trial","OWN BREATH 2","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Scheduled surgical procedure or intervention under general anesthesia\n* Capacity to give informed consent (free and independent decision-making capacity)\n* Willingness to provide written informed consent after comprehensive verbal and written information about study aims, procedures, and risks\n\nExclusion Criteria:\n\n* Lack of, or withdrawal of, written informed consent\n* Lack of capacity to consent or legal guardianship for health-related decisions\n* Insufficient German language skills for qualified verbal and written informed consent (exclusion to protect patients, since legally valid and substantively meaningful consent is not possible without secured language comprehension)\n* Pregnancy or breastfeeding\n* Current opioid therapy or chronic opioid therapy discontinued less than 1 month before the procedure\n* Known drug or alcohol dependence\n* Known hypersensitivity or allergy to lidocaine or its excipients (glycerol, propyl-4-hydroxybenzoate, methyl-4-hydroxybenzoate)\n* Severe psychiatric disorder impairing capacity to consent or to cooperate\n* Indication for nasal intubation\n* Non-pain-related limitation of mouth opening to less than 16 mm\n* Severe comorbidities with particular risk in the context of the study intervention (e.g., unstable cardiac or pulmonary disease, uncontrolled epilepsy)\n* Participation in another clinical study within the previous 30 days that could influence the present study question","ALL","18 Years",{"count":70,"type":71},200,"ESTIMATED","INTERVENTIONAL",[74],"NA","The purpose of this clinical trial is to investigate whether the videolaryngoscope i-scoop makes airway management under spontaneous breathing and analgosedation more clinically practicable than the established standard device, the C-Mac D-Blade videolaryngoscope, in adults undergoing surgery under general anesthesia.\n\nThe main questions it aims to answer are:\n\n• Is good clinical practicability - defined as a successful, easy, and complication-free intubation under spontaneous breathing - more frequently achieved with the i-scoop than with the C-Mac D-Blade?\n\nResearchers will compare the standardized airway management procedure under spontaneous breathing using either the i-scoop or the C-Mac D-Blade.\n\nParticipants will:\n\n* continue breathing on their own during the procedure\n* be randomly assigned (1:1) to one of the two videolaryngoscopes\n* receive standardized analgosedation and topical lidocaine anesthesia of the upper airway before the breathing tube is placed\n* be asked about discomfort and recall of the procedure after surgery (in the recovery room, on postoperative day 1, and at 7 days post-intubation) by a blinded interviewer",[77],"Airway Management",[79,80,81,82,83,84,85,86,87,88],"Videolaryngoscope","i-scoop","C-Mac D-Blade","Spontaneous breathing","Conscious sedation","Analgosedation","Topical airway anesthesia","Bladeless laryngoscope","Anatomy-guided intubation","Clinical practicability","2026-06-20",{"date":91,"type":92},"2026-06-25","ACTUAL",{"date":94,"type":92},"2026-06-18",{"date":96,"type":71},"2028-04-30",{"name":5,"class":6},1]