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I-scoop vs. C-Mac D-Blade Videolaryngoscope for Airway Management Under Spontaneous Breathing and Analgosedation
Sponsor: Hannover Medical School
Summary
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. The main questions it aims to answer are: • 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? Researchers will compare the standardized airway management procedure under spontaneous breathing using either the i-scoop or the C-Mac D-Blade. Participants will: * continue breathing on their own during the procedure * be randomly assigned (1:1) to one of the two videolaryngoscopes * receive standardized analgosedation and topical lidocaine anesthesia of the upper airway before the breathing tube is placed * 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
Official title: Practicability of Airway Management With the Videolaryngoscopes I-scoop and C-Mac D-Blade Under Spontaneous Breathing and Analgosedation - A Prospective, Randomized, Monocentric Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2026-06-18
Completion Date
2028-04-30
Last Updated
2026-06-03
Healthy Volunteers
No
Conditions
Interventions
Airway management under spontaneous breathing with the i-scoop videolaryngoscope
Single intervention during anesthesia induction: 1. Preoxygenation via FFP2 mask, 18 L/min O₂ until intubation. 2. Analgosedation: remifentanil 0.3 µg/kg + propofol 0.6 mg/kg bolus, then continuous infusion; max. one additional remifentanil bolus (0.3 µg/kg); midazolam 1 mg if needed. 3. Topical anesthesia: 150-200 mg lidocaine 1% oropharyngeally, then 20 mg lidocaine 1% endotracheally via i-scoop channel. 4. Intubation 60-90 s later under continuous visual control via dual-optic sub-epiglottic i-scoop positioning. 5. 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.
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: 1. Preoxygenation via FFP2 mask, 18 L/min O₂ until intubation. 2. Analgosedation: remifentanil 0.3 µg/kg + propofol 0.6 mg/kg bolus, then continuous infusion; max. one additional remifentanil bolus (0.3 µg/kg); midazolam 1 mg if needed. 3. 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). 4. 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.
Locations (1)
Hannover Medical School
Hanover, Lower Saxony, Germany