RecruitingNot ApplicableNCT07624162

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


Sponsor

Hannover Medical School

Enrollment

200 participants

Start Date

Jun 18, 2026

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Airway management under spontaneous breathing with the C-Mac D-Blade videolaryngoscope and a procedure called Airway management under spontaneous breathing with the i-scoop videolaryngoscope for people with airway management. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREAirway 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.

PROCEDUREAirway 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

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NCT07624162


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