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Clinical Trials in Germany / NCT07624162
Recruiting Not applicable

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

NCT07624162 · tracked via the Priya Life Science Germany tracker
Phase
Not applicable
Started
2026-06-18
Last updated
2026-06-25

Condition(s) studied

Airway Management

Investigational drug(s) / intervention(s)

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

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.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Hannover Medical School Hanover Lower Saxony Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07624162 on ClinicalTrials.gov ↗ ← All trials in Germany