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

NCT07624162 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-06-25

No results posted yet for this 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

Conditions

  • Airway Management

Interventions

PROCEDURE

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.

PROCEDURE

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.

Sponsors & Collaborators

  • Hannover Medical School

    lead OTHER

Principal Investigators

  • Konstantinos Raymondos, Professor, MD · Hannover Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-18
Primary Completion
2027-12-24
Completion
2028-04-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07624162 on ClinicalTrials.gov