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โ† Trials
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I-scoop vs. C-Mac D-Blade Videolaryngoscope for Airway Management Under Spontaneous Breathing and Analgosedation

RecruitingNAAges 18 Years - anyAllHannover Medical School
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In plain words

What the trial is, and whether it could suit you

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: โ€ข 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 topic

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age โ‰ฅ 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
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What it tests

  • Airway management under spontaneous breathing with the i-scoop videolaryngoscope
  • Airway management under spontaneous breathing with the C-Mac D-Blade videolaryngoscope
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Where

1 site
Hannover Medical School
Hanover, Germany
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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