I-scoop vs. C-Mac D-Blade Videolaryngoscope for Airway Management Under Spontaneous Breathing and… (NCT07624162) | Clinical Trial Compass
RecruitingNot Applicable
I-scoop vs. C-Mac D-Blade Videolaryngoscope for Airway Management Under Spontaneous Breathing and Analgosedation
Germany200 participantsStarted 2026-06-18
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants Achieving Good Clinical Practicability of Airway Management Under Spontaneous Breathing and Analgosedation
Timeframe: Intraoperatively from videolaryngoscope insertion until 5 minutes after intubation (T1); at 15-30 minutes after extubation in the recovery room (T2); on postoperative day 1 (T3); at 7 days after intubation (T4).