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

NCT07624162 | Not Yet Recruiting

• 2 other identifiers: 12062-BO-S-2025DRKS00039869
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Videolaryngoscope; i-scoop; C-Mac D-Blade; Spontaneous breathing; Conscious sedation; Analgosedation; Topical airway anesthesia; Bladeless laryngoscope; Anatomy-guided intubation; Clinical practicability

Outcome Measures

Primary Outcomes (1)

• Number of Participants Achieving Good Clinical Practicability of Airway Management Under Spontaneous Breathing and Analgosedation

  A composite dichotomous endpoint (yes/no) per participant. Good clinical practicability is achieved if all 12 predefined criteria are simultaneously met. Safety: (1) clear glottic view (Cormack-Lehane grade 1) before tube placement; (2) visual confirmation of correct endotracheal placement per PUMA consensus criteria (with the tube clearly seen between the vocal cords and/or above the arytenoids). Ease of performance: (3) VIDIAC score ≤0; (4) first-attempt success; (5) no more than three corrective maneuvers; (6) intubation time ≤60 seconds. Complication and complaint freedom: (7) no recall of laryngoscopy (including the first laryngoscopy for endotracheal lidocaine application) or intubation; (8) no SpO₂ \<90%; (9) no persistent apnea; (10) no clinically relevant hemodynamic instability; (11) no aspiration; (12) no relevant or persistent complaints/injuries (VAS \>3/10 at any postoperative time point, or persistent at 7 days).

  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).

Secondary Outcomes (16)

• Successful Intubation on the First Attempt

  Intraoperatively, during the intubation procedure (T1)

• Intubation Time

  Intraoperatively, during the intubation procedure (T1)

• Number of Optimization Maneuvers Required for Intubation

  Intraoperatively, during the intubation procedure (T1)

• Visual Quality of Laryngoscopy (Cormack-Lehane Grade and POGO Score)

  Intraoperatively, during the intubation procedure (T1)

• Number of Participants With Hypoxemia

  Intraoperatively, from start of analgosedation until 5 minutes after intubation (T1)

Study Arms (2)

i-scoop Videolaryngoscope Group

EXPERIMENTAL

Participants assigned to this arm undergo airway management under spontaneous breathing and analgosedation using the i-scoop videolaryngoscope. Unlike conventional videolaryngoscopes, the i-scoop has no blade and follows the natural anatomy of the upper airway along the hard palate, comparable to laryngeal mask insertion. Two lateral optics are positioned sub-epiglottically immediately in front of the laryngeal inlet. Because the integrated tube guidance ends at the same location, the line of sight and the working axis of the tube coincide directly in front of the laryngeal inlet, allowing tube placement under continuous visual control from two perspectives. Intervention assigned: Procedure: Airway management with i-scoop videolaryngoscope under spontaneous breathing and analgosedation

Procedure: Airway management under spontaneous breathing with the i-scoop videolaryngoscope

C-MAC D-Blade Videolaryngoscope Group

ACTIVE COMPARATOR

Participants assigned to this arm undergo standardized airway management under spontaneous breathing and analgosedation using the hyperangulated C-Mac D-Blade videolaryngoscope, the established institutional standard at Hannover Medical School for videolaryngoscopic airway management in patients with anticipated difficult airway. The C-Mac D-Blade has a hyperangulated blade with the camera at the blade tip; the tube is placed using a pre-shaped endotracheal tube or a pre-formed stylet. Endotracheal lidocaine is delivered via a separate applicator, since the device has no integrated tube guidance or applicator channel. Intervention assigned: Procedure: Airway management with C-Mac D-Blade videolaryngoscope under spontaneous breathing and analgosedation

Procedure: Airway management under spontaneous breathing with the C-Mac D-Blade videolaryngoscope

Interventions

Airway management under spontaneous breathing with the i-scoop videolaryngoscope PROCEDURE

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.

i-scoop Videolaryngoscope Group

Airway management under spontaneous breathing with the C-Mac D-Blade videolaryngoscope PROCEDURE

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.

C-MAC D-Blade Videolaryngoscope Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Lack of, or withdrawal of, written informed consent
• Lack of capacity to consent or legal guardianship for health-related decisions
• 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

Sponsors & Collaborators

• Hannover Medical School: lead

Study Sites (1)

Hannover Medical School

Hanover, Lower Saxony, 30625, Germany

Location

Related Publications (6)

• Raymondos K. The i-scoop: a laryngoscope with new perspectives. Anaesthesia. 2012 Jan;67(1):78. doi: 10.1111/j.1365-2044.2011.06951.x. No abstract available.

  PMID: 22150493 BACKGROUND

• Raymondos K, Seidel T, Sander B, Gerdes A, Goetz F, Helmstadter V, Panning B, Dieck T. The intubation scoop (i-scoop) - a new type of laryngoscope for difficult and normal airways. Anaesthesia. 2014 Sep;69(9):990-1001. doi: 10.1111/anae.12754. Epub 2014 Jun 4.

  PMID: 24894025 BACKGROUND

• Cumberworth A, Lewith H, Sud A, Jefferson H, Athanassoglou V, Pandit JJ. Major complications of airway management: a prospective multicentre observational study. Anaesthesia. 2022 Jun;77(6):640-648. doi: 10.1111/anae.15668. Epub 2022 Mar 7.

  PMID: 35254669 BACKGROUND

• Chrimes N, Higgs A, Hagberg CA, Baker PA, Cooper RM, Greif R, Kovacs G, Law JA, Marshall SD, Myatra SN, O'Sullivan EP, Rosenblatt WH, Ross CH, Sakles JC, Sorbello M, Cook TM. Preventing unrecognised oesophageal intubation: a consensus guideline from the Project for Universal Management of Airways and international airway societies. Anaesthesia. 2022 Dec;77(12):1395-1415. doi: 10.1111/anae.15817. Epub 2022 Aug 17.

  PMID: 35977431 BACKGROUND

• Kohse EK, Siebert HK, Sasu PB, Loock K, Dohrmann T, Breitfeld P, Barclay-Steuart A, Stark M, Sehner S, Zollner C, Petzoldt M. A model to predict difficult airway alerts after videolaryngoscopy in adults with anticipated difficult airways - the VIDIAC score. Anaesthesia. 2022 Oct;77(10):1089-1096. doi: 10.1111/anae.15841. Epub 2022 Aug 25.

  PMID: 36006056 BACKGROUND

• Russotto V, Myatra SN, Laffey JG, Tassistro E, Antolini L, Bauer P, Lascarrou JB, Szuldrzynski K, Camporota L, Pelosi P, Sorbello M, Higgs A, Greif R, Putensen C, Agvald-Ohman C, Chalkias A, Bokums K, Brewster D, Rossi E, Fumagalli R, Pesenti A, Foti G, Bellani G; INTUBE Study Investigators. Intubation Practices and Adverse Peri-intubation Events in Critically Ill Patients From 29 Countries. JAMA. 2021 Mar 23;325(12):1164-1172. doi: 10.1001/jama.2021.1727.

  PMID: 33755076 BACKGROUND

Study Officials

• Konstantinos Raymondos, Professor, MD

  Hannover Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Konstantinos Raymondos, Professor, MD

CONTACT

+49 176 1 532 3317; Raymondos.Konstantinos@mh-hannover.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants are blinded to group allocation. The investigator performing the airway procedure cannot be blinded due to the visible nature of the device. The outcomes assessor for postoperative complaint interviews (T2, T3, T4) is blinded to the assigned device.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant, Department of Anesthesiology and Intensive Care Medicine

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: June 3, 2026
• Study Start (Estimated): June 18, 2026
• Primary Completion (Estimated): December 24, 2027
• Study Completion (Estimated): April 30, 2028
• Last Updated: June 3, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)