I-scoop vs. C-Mac D-Blade Videolaryngoscope for Airway Management Under Spontaneous Breathing and Analgosedation (OWN BREATH 2)

Practicability of Airway Management With the Videolaryngoscopes I-scoop and C-Mac D-Blade Under Spontaneous Breathing and Analgosedation - A Prospective, Randomized, Monocentric Trial

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

Study Overview

• Status: Not yet recruiting
• Conditions: Airway Management
• Intervention / Treatment: Procedure: Airway management under spontaneous breathing with the i-scoop videolaryngoscope; Procedure: Airway management under spontaneous breathing with the C-Mac D-Blade videolaryngoscope

Detailed Description

1. Background - The Care Gap in Spontaneous-Breathing Airway Management

Despite clear national and international guideline recommendations, airway management under preserved spontaneous breathing is performed in only 0.2% of all routine cases of tracheal intubation, and in only 2.7% of cases where a difficult airway is anticipated (Cumberworth et al., Anaesthesia 2022). This is a striking implementation gap, given that severe complications occur up to 45-fold more often in patients with anticipated difficult airways than in those with anticipated normal airways - exactly the population that would benefit most from preserved spontaneous breathing during intubation.

The reason for this implementation gap is not a lack of awareness among anesthesiologists, nor a lack of suitable equipment. It is the limited clinical practicability of the currently established procedures: they are technically demanding, time-consuming, require extensive operator experience, and are often associated with patient discomfort.

Three interdependent factors determine the practicability of airway management under spontaneous breathing and analgosedation:

1. Videolaryngoscopy: a less invasive laryngoscopy permits lighter sedation and preserves spontaneous breathing.
2. Topical airway anesthesia: reliable suppression of airway reflexes reduces the need for deep sedation.
3. Analgosedation: lower-dose, well-titrated sedation preserves spontaneous breathing and protective reflexes longer.

Each factor influences the others. A truly practicable procedure requires that all three are optimized in parallel - not as isolated technical components but as a coherent overall procedure. This trial addresses the question of whether such an optimized overall procedure, combined with a less invasive videolaryngoscope, can close the implementation gap.

2. Historical Context

More Than 130 Years of Blade-Based Laryngoscopy The principle of direct laryngoscopy was first described by Alfred Kirstein in 1895, who introduced the "autoscope" - an L-shaped device with an electric light source and a curved blade that elevated the epiglottis to reveal the glottis. In 1943, Robert R. Macintosh introduced the laryngoscope that has remained the clinical standard ever since: a similarly curved blade that elevates the tongue base and lifts the epiglottis indirectly to align the oral, pharyngeal, and tracheal axes into a single straight visual line.

For more than 130 years, this fundamental principle has remained essentially unchanged. Every modern videolaryngoscope - including hyperangulated devices such as the C-Mac D-Blade, the Storz C-Mac, the GlideScope, the McGrath, the Airtraq, and the Pentax Airway Scope - still uses a blade to elevate the tongue and to lift the epiglottis. The blade is the mechanical interface between the operator and the airway anatomy.

This blade-based design has consequences. To position the camera in front of the laryngeal inlet, the blade must displace the tongue base, the soft tissues of the neck, and the mandible. This displacement requires the natural double-curved course of the upper airway (with two near-90° angles around the tongue base and entering the trachea) to be deformed into an approximately straight line of sight. In patients under general anesthesia with full muscle relaxation, this deformation is generally feasible. In patients under preserved spontaneous breathing and analgosedation - without muscle relaxation - the deformation is much less feasible, more invasive, and more likely to provoke airway reflexes such as cough, laryngospasm, or tube placement failure.

The OWN-BREATH 2 trial therefore investigates whether departing from the blade-based design - toward a bladeless, anatomy-guided videolaryngoscope - improves the clinical practicability of airway management under spontaneous breathing.

3. The i-scoop - A Bladeless, Anatomy-Guided Concept

The intubation scoop (i-scoop) was developed at Hannover Medical School and has been a CE-certified medical device since 2021 (CE conformity declaration most recently updated on 2025-11-19). It is manufactured by Vimed Medical Device, China; its development was jointly funded by Vimed and by Supporting Health Care, Netherlands.

Unlike all other videolaryngoscopes, the i-scoop has no blade. Instead, it consists of a thin, curved guiding bar that follows the natural anatomy of the upper airway - comparable to laryngeal mask insertion along the hard palate. A short, separately operated lever lifts the epiglottis. This decoupled design allows the optical system to be advanced into a sub-epiglottic position immediately in front of the laryngeal inlet, without the airway needing to be deformed into a straight visual line.

Two laterally placed optics provide simultaneous views of the laryngeal inlet from two perspectives. An integrated tube guide channel ends at the same sub-epiglottic position as the optics. As a consequence, the line of sight and the working axis of the endotracheal tube coincide directly in front of the laryngeal inlet. Tube placement into the trachea can therefore be guided, observed, and visually confirmed during the entire passage - from two perspectives - without losing visual contact with the glottis. This is a fundamental difference from blade-based videolaryngoscopes, in which the tube progressively obstructs the camera view during placement and the operator must rely on memory or stylet pre-shaping.

The intended consequences of this design are: less invasive insertion (no displacement of tongue base, soft tissues of the neck, or mandible), reduced provocation of airway reflexes, lower required sedation depth, and improved visual control of tube placement throughout passage. Whether these design features translate into better clinical practicability under spontaneous breathing and analgosedation is the question this trial addresses.

4. Pre-Existing Evidence

The rationale and design of the OWN BREATH 2 trial are informed by three lines of prior evidence and preliminary clinical experience:

1. Manikin Study (Raymondos et al., Anaesthesia 2014; 69:990-1001): A controlled study compared the i-scoop with eleven other videolaryngoscopes (Macintosh, GlideScope GVL/AVL/DI Trainer, McGrath Series 5/MAC, C-Mac with Macintosh blade and C-Mac D-Blade, A.P. Advance, A.P. Advance DAB, Airway Scope, Airtraq) in a simulated normal and a simulated difficult airway, performed by 25 board-certified anesthesiologists with extensive videolaryngoscopy experience. In the simulated difficult airway (modified retrognathia plus immobilized cervical spine), all 25 anesthesiologists achieved successful intubation with the i-scoop with a clear glottic view; success rates with the other devices ranged from 0% (Macintosh and most videolaryngoscopes) to 40% (Airtraq) and 20% (Airway Scope) (p < 0.001 vs. all twelve comparator devices combined). In the simulated normal airway, intubation with the i-scoop was even faster than with the standard Macintosh laryngoscope (p < 0.02). This study established the proof-of-concept of the bladeless, anatomy-guided design.
2. First Clinical Experience in Anesthetized Patients (Raymondos, EAMS Baveno September 2023): The CE-certified i-scoop was used in 125 anesthetized adult patients; data from 103 patients with written consent for scientific analysis were evaluated. All 103 patients were successfully intubated on the first attempt under Cormack-Lehane grade 1 view. The Percentage of Glottic Opening (POGO) score was 100% in 96 patients and 80-95% in 7 patients. In 90 patients intubated by one experienced operator, optimal glottic view was achieved at a median of 5 seconds (range 2-22) after tooth passage, and intubation was completed at a median of 4 seconds (range 1-57). In 13 patients intubated by four first-time users, these times were approximately twice as long (medians 13 s and 8 s, respectively). The VIDIAC (Videolaryngoscopic Intubation and Difficult Airway Classification) score was -1 (range -1 to 0) and the Intubation Difficulty Scale was 0 (range 0 to 5).
3. First Clinical Experience under Spontaneous Breathing - OWN BREATH 1 (Raymondos, WAMM Florence, November 2025): A retrospective analysis of the first 41 consecutive elective urological patients intubated under preserved spontaneous breathing and analgosedation using the i-scoop, after introduction of the standardized overall procedure on 2025-05-13 (data evaluated under separate ethics approval, reference 12063-BO-K-2025). Results: 35 of 41 patients (85%) met all 12 predefined criteria of "good clinical practicability". A clear glottic view (Cormack-Lehane grade 1, VIDIAC score -1) was achieved in all 41 patients; the median POGO score was 100% (range 75-100). First-attempt success was 90% (37/41); 98% were intubated within two attempts and 100% within three. One experienced operator (n = 34) intubated at a median time of 18 seconds (range 6-80); three first-time users (n = 7) required approximately three-fold longer (median 55 s, range 24-59). All 9 patients with an El-Ganzouri Index ≥ 4 (anticipated difficult airway) met all 12 criteria of good clinical practicability; in the 6 patients who did not meet all criteria, an anticipated difficult airway was never present. No serious complications occurred; no patient recalled the laryngoscopy or the intubation. Failure to achieve all 12 criteria was attributable in all 6 cases to insufficient topical anesthesia or sedation, not to insufficient visualization or device performance.

These three sources motivate the hypothesis of the present prospective, randomized comparison.

5. OWN-BREATH 2 - Study Design and Hypothesis

OWN-BREATH 2 is a prospective, randomized, monocentric, parallel-group trial conducted at the Department of Anaesthesiology and Intensive Care Medicine, Hannover Medical School, Germany. The Ethics Committee of Hannover Medical School approved the trial without reservations on 2026-01-15 (reference number 12062-BO-S-2025; approved study protocol AG-AuA-QM-Version V14.7 of 2025-12-14).

A total of 200 adult patients (≥ 18 years) scheduled for surgery under general anesthesia at the study center will be enrolled - independently of whether their airway is judged anatomically normal or difficult. Patients are allocated 1:1 to either the experimental arm (airway management with the i-scoop) or the active comparator arm (airway management with the established hyperangulated C-Mac D-Blade videolaryngoscope manufactured by Karl Storz SE & Co. KG, Tuttlingen, Germany). Allocation is centrally generated using a computerized randomization plan with permuted blocks of variable length and is concealed via sequentially numbered, opaque, sealed envelopes opened immediately before intervention.

The standardized overall procedure is identical in both arms except for the videolaryngoscope used. Patients are blinded to their group allocation. The operator cannot be blinded due to the visible nature of the device. Postoperative outcome assessors performing the structured patient interviews (recovery room, postoperative day 1, and 7 days post-intubation) are blinded to the assigned device.

Hypothesis: Because the line of sight and the working axis of the endotracheal tube coincide directly in front of the laryngeal inlet with the i-scoop, tube placement into the trachea can be guided under continuous visual control and visually confirmed throughout passage. This fundamental mechanical and optical advantage, in comparison with blade-based videolaryngoscopes, leads to the hypothesis that the standardized airway management procedure under spontaneous breathing and analgosedation more frequently meets the predefined composite endpoint of "good clinical practicability" with the i-scoop than with the C-Mac D-Blade.

Clinical implication: Improved clinical practicability would create the prerequisite for broader integration of spontaneous-breathing airway management into routine clinical practice - and thereby better serve the patient population with anticipated difficult airways, in whom the complication risk is currently 45-fold higher.

6. Standardized Procedure and Measurement Methodology

Analgosedation in both arms uses the following standardized scheme (reference weight, gender-independent: body height in cm minus 100): initial bolus of remifentanil 0.3 µg/kg and propofol 0.6 mg/kg; subsequent continuous infusion via syringe pump of remifentanil 0.05 µg/kg/min and propofol 2 mg/kg/h; on-demand boluses of propofol 0.3 mg/kg without quantity limit. For safety reasons - to prevent escalating sedation depth with loss of spontaneous breathing - remifentanil on-demand boluses are restricted to a maximum of one additional bolus of 0.3 µg/kg per procedure. Anxiolysis if required: midazolam 1 mg.

Topical airway anesthesia: 150-200 mg lidocaine 1% oropharyngeally in repeated single doses at intervals of 15-30 seconds, followed by videolaryngoscope-guided endotracheal application of 20 mg lidocaine 1% (in the i-scoop arm via the integrated channel; in the C-Mac D-Blade arm via a separate applicator). Intubation is performed 60-90 seconds after the endotracheal lidocaine application.

Oxygenation: continuous oxygen delivery at 18 L/min via FFP2 face mask is maintained from preoxygenation until successful intubation, with a target end-tidal oxygen fraction of ≥ 0.60.

Continuous monitoring during the procedure includes pulse oximetry, electrocardiography, non-invasive blood pressure measurement, impedance respirography, capnography, and processed electroencephalography for sedation depth.

Confirmation of correct endotracheal tube placement is performed by continuous capnography according to the consensus criteria of the Project for Universal Management of Airways (PUMA): seven consecutive carbon dioxide waveforms with a maximum value of at least 7.5 mmHg.

Standardized operator training prior to study start: each participating board-certified anesthesiologist completes at least 30 successful intubations and at least 30 successful endotracheal local anesthesia applications per device on the airway trainer (with scenarios of varying difficulty, including restricted mouth opening and reduced glottic mobility), followed by clinically supervised use until safe handling is achieved. More than ten board-certified anesthesiologists participate in the trial; the operator identifier is included as a covariate in multivariate statistical analyses.

Predefined escalation steps are available if visualization is insufficient or if tube placement is not feasible with the assigned device, including crossover to the alternative study device. Established airway adjuncts (e.g., laryngeal mask, fiberoptic bronchoscope) and standard rescue strategies remain available throughout. Patient safety has priority over adherence to the assigned study intervention.

Primary endpoint: good clinical practicability - a composite dichotomous endpoint requiring simultaneous fulfillment of 12 predefined criteria across three domains (safety: clear glottic view and PUMA-confirmed endotracheal placement; ease of performance: VIDIAC ≤ 0, first-attempt success, ≤ 3 corrective maneuvers, intubation time ≤ 60 s; complication and complaint freedom: no recall of laryngoscopy or intubation, no SpO₂ < 90%, no persistent apnea, no clinically relevant hemodynamic instability, no aspiration, no relevant or persistent complaints/injuries). Detailed criteria are described in the Outcome Measures module of this registration.

Sample size: 100 patients per arm, calculated for detection of a difference of 23.3 percentage points in the proportion meeting good clinical practicability (assumed: 90% with i-scoop, based on the OWN BREATH 1 pilot extrapolated to optimized routine conditions; 66.7% with C-Mac D-Blade, based on the published literature) using a two-sided exact Fisher test at α = 0.01 with 90% power. Confirmatory analysis: Pearson chi-square test (without continuity correction), two-sided, α = 0.01; effect measure: absolute difference of proportions with two-sided 99% confidence interval.

7. Patent Disclosures and Conflicts of Interest

Patents and patent-related income: Patents on the i-scoop are granted in the name of Hannover Medical School (European Union and United States of America). Additional patents are pending, some filed jointly with the industrial partners Vimed Medical Device, China, and Supporting Health Care, Netherlands, as co-patent holders. The principal investigator (Konstantinos Raymondos) holds a separate i-scoop patent solely in his own name. Patent-related payments to Hannover Medical School and/or to the principal investigator may arise during the trial period from ongoing or future licensing or exclusivity agreements; such payments are unrelated to the conduct of OWN-BREATH 2 itself but are disclosed here proactively because they may occur during the trial. At the time of registration, no such payments have been made or are concretely scheduled; updates will be made through the trial register and in subsequent publications.

Industrial cooperation without study sponsoring: Vimed Medical Device and Supporting Health Care jointly funded the technical development of the i-scoop in the years preceding study start, and both provide the i-scoop videolaryngoscopes and consumables for OWN-BREATH 2 free of charge. Neither company provides honoraria, expense reimbursement, or other monetary compensation for the conduct of this trial to Hannover Medical School, the study team, or the participants. The device is not yet commercially available.

Independence of trial conduct: All decisions on study design, data acquisition, analysis, and publication are made exclusively by the study team at Hannover Medical School. The Sponsor of the trial is Hannover Medical School.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Konstantinos Raymondos, Professor, MD; Phone Number: +49 176 1 532 3317; Email: Raymondos.Konstantinos@mh-hannover.de

Study Locations

• Germany
  • Lower Saxony
    • Hanover, Lower Saxony, Germany, 30625
      • Hannover Medical School
      • Contact: Konstantinos Raymondos, Professor, MD; Phone Number: +49 176 1 532 3317; Email: Raymondos.Konstantinos@mh-hannover.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: i-scoop Videolaryngoscope Group; 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; Single intervention during anesthesia induction: Preoxygenation via FFP2 mask, 18 L/min O₂ until intubation.; 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.; Topical anesthesia: 150-200 mg lidocaine 1% oropharyngeally, then 20 mg lidocaine 1% endotracheally via i-scoop channel.; Intubation 60-90 s later under continuous visual control via dual-optic sub-epiglottic i-scoop positioning.; 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.
Active Comparator: C-MAC D-Blade Videolaryngoscope Group; 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; Single intervention during anesthesia induction, identical to Intervention 1 except for the videolaryngoscope used: Preoxygenation via FFP2 mask, 18 L/min O₂ until intubation.; 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.; 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).; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful Intubation on the First Attempt	Successful placement of the endotracheal tube during the first laryngoscopy and first tube placement attempt, confirmed by exhaled carbon dioxide. Participants are classified dichotomously as first-attempt success or no first-attempt success.	Intraoperatively, during the intubation procedure (T1)
Intubation Time	Time from insertion of the videolaryngoscope until the first exhaled carbon dioxide signal after successful tube placement, measured in seconds. Lower values indicate easier and faster intubation.	Intraoperatively, during the intubation procedure (T1)
Number of Optimization Maneuvers Required for Intubation	Number of additional maneuvers required to achieve successful tube placement, including repositioning of the device, external laryngeal manipulation, or correction of tube direction. Lower values indicate easier intubation.	Intraoperatively, during the intubation procedure (T1)
Visual Quality of Laryngoscopy (Cormack-Lehane Grade and POGO Score)	Cormack-Lehane classification of the glottic view and Percentage of Glottic Opening (POGO) score before tube placement. Assessed on the videolaryngoscope monitor by the operator and by a blinded second observer using pseudonymized video recordings.	Intraoperatively, during the intubation procedure (T1)
Number of Participants With Hypoxemia	Hypoxemia is defined as peripheral oxygen saturation below 90%, or a decrease of more than 10% from baseline during the procedure. Participants are classified dichotomously as with or without hypoxemia.	Intraoperatively, from start of analgosedation until 5 minutes after intubation (T1)
Number of Participants With Hemodynamic Events	Hemodynamic events include clinically relevant hypotension (systolic blood pressure <70 mmHg), arrhythmias, signs of myocardial ischemia, or the need for catecholamine treatment. Participants are classified dichotomously as with or without hemodynamic events.	Intraoperatively, from start of analgosedation until 5 minutes after intubation (T1)
Number of Participants With Aspiration or Suspected Aspiration	Aspiration or suspected aspiration occurring during airway management. Suspected by videolaryngoscopic appearance and confirmed or excluded by bronchoscopy if needed. Participants are classified dichotomously as with or without aspiration.	Intraoperatively, during the intubation procedure (T1)
Number of Participants With Bronchospasm	Bronchospasm requiring treatment during or immediately after intubation. Participants are classified dichotomously as with or without bronchospasm.	Intraoperatively, during and immediately after the intubation procedure (T1)
Number of Apnea Episodes During Sedation	Number, duration, and presumed cause of apnea episodes (cessation of spontaneous breathing) during analgosedation, recorded by impedance respirography and capnography.	Intraoperatively, from start of analgosedation until intubation (T1)
Effectiveness of Supportive Airway Maneuvers	Effectiveness of standardized supportive maneuvers (chin lift, verbal request to breathe, jaw thrust, oral airway, pressure-supported mask ventilation) when applied during analgosedation. Documented per maneuver as effective or not effective.	Intraoperatively, during analgosedation until intubation (T1)
Number of Participants With Postoperative Throat Complaints	Postoperative complaints include sore throat, difficulty swallowing, hoarseness, speech disturbances, numbness, or altered taste. Severity is rated on a visual analogue scale (0-10). Participants are classified dichotomously as with or without complaints; persistence at 7 days counts even with VAS ≤3. Assessed by a blinded interviewer.	At 15-30 minutes after extubation in the recovery room (T2), on postoperative day 1 (T3), and at 7 days after intubation (T4)
Participant-Rated Unpleasantness of the Procedure	Subjective unpleasantness of the procedure assessed using a visual analogue scale ranging from 0 (no unpleasantness) to 10 (worst imaginable unpleasantness). Assessed by a blinded interviewer.	At 15-30 minutes after extubation in the recovery room (T2)
Number of Participants With Recall of Procedural Steps	Participant recall of any procedural step, assessed during postoperative interviews by a blinded interviewer using a structured questionnaire (Fragebogen postoperativ V1.1, dated 2025-12-14). Items recorded include: oral lidocaine application, endotracheal lidocaine application, cough, dyspnea, anxiety, laryngoscopy, and intubation. Participants are classified per item as with or without recall.	At 15-30 minutes after extubation in the recovery room (T2), on postoperative day 1 (T3), and at 7 days after intubation (T4)
Participant Global Rating of the Procedure	Overall participant rating of the airway management procedure on a Likert scale, assessed during the postoperative interview by a blinded interviewer. Higher ratings indicate better acceptance of the procedure.	At 7 days after intubation (T4)
Intubator-Rated Practicality of the Procedure	Overall rating of the practicality and handling of the procedure by the clinician performing the intubation, on a standardized scale. Higher ratings indicate better practicality and easier handling.	Immediately after completion of the procedure (T1)
Effect of Operator Experience on Practicability (Subgroup Analysis)	Exploratory subgroup analysis of the proportion of participants achieving the primary endpoint, stratified by the operator's documented prior experience with the i-scoop and with videolaryngoscopy in general. Subgroup thresholds will be predefined in the statistical analysis plan before unblinding.	At completion of the study, based on intraoperative documentation (T1)

Collaborators and Investigators

• Sponsor: Hannover Medical School
• Investigators: Principal Investigator: Konstantinos Raymondos, Professor, MD, Hannover Medical School

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): June 18, 2026
• Primary Completion (Estimated): December 24, 2027
• Study Completion (Estimated): April 30, 2028

Study Registration Dates

• First Submitted: May 20, 2026
• First Submitted That Met QC Criteria: May 31, 2026
• First Posted (Actual): June 3, 2026

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: May 31, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Spontaneous breathing; Conscious sedation; Videolaryngoscope; Analgosedation; i-scoop; C-Mac D-Blade; Topical airway anesthesia; Bladeless laryngoscope; Anatomy-guided intubation; Clinical practicability
• Other Study ID Numbers: 12062-BO-S-2025; DRKS00039869 (Registry Identifier: German Clinical Trials Register)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No