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NCT07624162
I-scoop vs. C-Mac D-Blade Videolaryngoscope for Airway Management Under Spontaneous Breathing and Analgosedation
Conditions: Airway Management
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 200
Sponsor: Hannover Medical School
Location: Hannover Medical School Hanover Lower Saxony
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 Criteria
Inclusion Criteria:
* Age ≥ 18 years
* Scheduled surgical procedure or intervention under general anesthesia
* Capacity to give informed consent (free and independent decision-making capacity)
* Willingness to provide written informed consent after comprehensive verbal and written information about study aims, procedures, and risks
Exclusion Criteria:
* Lack of, or withdrawal of, written informed consent
* Lack of capacity to consent or legal guardianship for health-related decisions
* 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)
* Pregnancy or breastfeeding
* Current opioid therapy or chronic opioid therapy discontinued less than 1 month before the procedure
* Known drug or alcohol dependence
* Known hypersensitivity or allergy to lidocaine or its excipients (glycerol, propyl-4-hydroxybenzoate, methyl-4-hydroxybenzoate)
* Severe psychiatric disorder impairing capacity to consent or to cooperate
* Indication for nasal intubation
* Non-pain-related limitation of mouth opening to less than 16 mm
* Severe comorbidities with particular risk in the context of the study intervention (e.g., unstable cardiac or pulmonary disease, uncontrolled epilepsy)
* Participation in another clinical study within the previous 30 days that could influence the present study question
Source: ClinicalTrials.gov (NCT07624162). StuddyBuddy aggregates publicly available trial information.
