Practicability of Airway Management with the Videolaryngoscopes i-scoop and C-Mac D-Blade Under Spontaneous Breathing and Analgosedation

Practicability of Airway Management with the Videolaryngoscopes i-scoop and C-Mac D-Blade Under Spontaneous Breathing and Analgosedation - OWN BREATH 2

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00039869

Enrollment

200

Registered

2026-05-21

Start date

2026-06-18

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Airway management in adult patients undergoing planned endotracheal intubation while maintaining spontaneous breathing and under analgosedation

Interventions

Group 1: Arm A — Intervention Arm: Airway Management with the Videolaryngoscope i-scoop Airway management procedure under preserved spontaneous breathing and analgosedation using the videolaryngoscop

development funding: Supporting Health Care, Netherlands

CE conformity since 2021, updated 19 November 2025). The i-scoop differs from established blade-based videolaryngoscopes in that it dispenses with a conventional blade. It follows the natural course o

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Planned surgical procedure or intervention under general anaesthesia. - Ability to make an independent and informed decision. - Written informed consent after comprehensive verbal and written information. - Sufficient German language skills to fully understand the study information, procedures, risks, and alternatives.

Exclusion criteria

Exclusion criteria: Exclusion criteria: - no written informed consent is available or consent is withdrawn. - the minimum age of 18 years has not been reached. - the participant lacks the capacity to consent or is under legal guardianship for healthcare decisions. - pregnancy or breastfeeding is present. - there is ongoing opioid therapy or chronic opioid therapy was discontinued no more than one month before the procedure. - there is known drug or alcohol dependence. - there is a severe psychiatric disorder associated with impaired ability to consent or cooperate. - the participant does not speak German or has only very limited German language skills. - there is a known hypersensitivity or allergy to lidocaine or the excipients used (glycerol, propyl-4-hydroxybenzoate, methyl-4-hydroxybenzoate). - there is an indication for nasal intubation. - there is a non-pain-related limitation of mouth opening to < 16 mm. - there are severe comorbidities associated with increased risk related to the study intervention (e.g. unstable cardiac or pulmonary disease, uncontrolled epilepsy). - participation in another clinical trial within the previous 30 days has occurred and could influence the present study question.

Design outcomes

Primary

Measure	Time frame
WHAT Proportion of patients achieving "good clinical practicability" of the overall airway management procedure under preserved spontaneous breathing and analgosedation. This is a combined dichotomous endpoint (yes / no) per patient. "Good clinical practicability" is considered achieved only when all twelve of the following pre-defined individual criteria are simultaneously met. These twelve criteria are organised into three domains: Safety of intubation: (1) Unambiguous view of the glottis or laryngeal inlet interpretable for tube guidance prior to tube advancement (Cormack–Lehane grade 1 without relevant obstruction of view), sufficient to assess glottic opening and enable targeted tube guidance. (2) Visual confirmation of correct endotracheal tube position in accordance with the consensus criteria of the Project for Universal Management of Airways (PUMA), with clearly visible tube position between the vocal cords and/or above the arytenoid cartilages. Simplicity of execution: (3) VIDIAC score (Videolaryngoscopic Intubation and Difficult Airway Classification) = 0 according to the published definition (Kohse et al., Anaesthesia 2022); in particular, a VIDIAC = 0 requires that the view was achieved without additional subepiglottic positioning or epiglottis loading of the optic — such manoeuvres are markers of increased laryngoscopic complexity in the VIDIAC score and result in score values > 0. (4) Success on the first initiated intubation attempt. This begins with insertion of the laryngoscope past the dental arch and is only considered successful once tube placement has subsequently been initiated (as defined in section 5.1.4 of the study protocol). (5) The manoeuvre limit is assessed separately for corrective manoeuvres with the videolaryngoscope and for corrective manoeuvres during tube placement; no more than three corrective manoeuvres may be required in each category during the first initiated intubation attempt. (6) Intubation duration = 60 seconds, measu	—

Measure

Time frame

WHAT Proportion of patients achieving "good clinical practicability" of the overall airway management procedure under preserved spontaneous breathing and analgosedation. This is a combined dichotomous endpoint (yes / no) per patient. "Good clinical practicability" is considered achieved only when all twelve of the following pre-defined individual criteria are simultaneously met. These twelve criteria are organised into three domains: Safety of intubation: (1) Unambiguous view of the glottis or laryngeal inlet interpretable for tube guidance prior to tube advancement (Cormack–Lehane grade 1 without relevant obstruction of view), sufficient to assess glottic opening and enable targeted tube guidance. (2) Visual confirmation of correct endotracheal tube position in accordance with the consensus criteria of the Project for Universal Management of Airways (PUMA), with clearly visible tube position between the vocal cords and/or above the arytenoid cartilages. Simplicity of execution: (3) VIDIAC score (Videolaryngoscopic Intubation and Difficult Airway Classification) = 0 according to the published definition (Kohse et al., Anaesthesia 2022); in particular, a VIDIAC = 0 requires that the view was achieved without additional subepiglottic positioning or epiglottis loading of the optic — such manoeuvres are markers of increased laryngoscopic complexity in the VIDIAC score and result in score values > 0. (4) Success on the first initiated intubation attempt. This begins with insertion of the laryngoscope past the dental arch and is only considered successful once tube placement has subsequently been initiated (as defined in section 5.1.4 of the study protocol). (5) The manoeuvre limit is assessed separately for corrective manoeuvres with the videolaryngoscope and for corrective manoeuvres during tube placement; no more than three corrective manoeuvres may be required in each category during the first initiated intubation attempt. (6) Intubation duration = 60 seconds, measu

—

Secondary

Measure	Time frame
Patient-related characteristics and preoperative risk factors The following variables are not secondary endpoints in the strict sense, but rather baseline characteristics, preoperative risk factors, and covariates. They serve to describe the study population, to verify the comparability of the randomised groups, and for exploratory adjusted analyses of the primary endpoint. WHAT: Demographic and anthropometric data (age, sex, height, weight, body mass index), ASA classification, anaesthesia-relevant comorbidities, preoperative airway assessment (El-Ganzouri index, Mallampati score, thyromental distance, mouth opening, cervical mobility, dental status), and individual risk constellations (in particular aspiration risk and anticipated difficulty of airway management). WHEN: Preoperatively before the start of analgosedation (T1). HOW: Collected from medical history, preoperative examination, and patient records; documented in the electronic study data capture file. B — Respiratory physiological parameters and course of analgosedation WHAT: Occurrence, duration, and presumed cause of respiratory arrests or relevant respiratory depression, including classification of each apnoea episode according to the study-specific AIRS score (Airway Intervention and Respiratory Support Score; levels 0–4: 0 = brief, self-limiting, no intervention; 1 = simple stimulation sufficient, e.g. chin lift or verbal prompt; 2 = firm stimulus required, e.g. jaw thrust, or apnoea duration > 60 seconds; 3 = no response to firm stimulus and/or mask ventilation required; 4 = ventilation via supraglottic airway or further escalation required); number of apnoea episodes per AIRS level; effectiveness of standardised respiratory support and respiratory measures (chin lift, verbal instruction to breathe, jaw thrust, oral airway, mask ventilation, and early inhaled salbutamol administration in cases of known risk or clinical suspicion of an emerging bronchospastic reaction following a pronou	—

Measure

Time frame

Patient-related characteristics and preoperative risk factors The following variables are not secondary endpoints in the strict sense, but rather baseline characteristics, preoperative risk factors, and covariates. They serve to describe the study population, to verify the comparability of the randomised groups, and for exploratory adjusted analyses of the primary endpoint. WHAT: Demographic and anthropometric data (age, sex, height, weight, body mass index), ASA classification, anaesthesia-relevant comorbidities, preoperative airway assessment (El-Ganzouri index, Mallampati score, thyromental distance, mouth opening, cervical mobility, dental status), and individual risk constellations (in particular aspiration risk and anticipated difficulty of airway management). WHEN: Preoperatively before the start of analgosedation (T1). HOW: Collected from medical history, preoperative examination, and patient records; documented in the electronic study data capture file. B — Respiratory physiological parameters and course of analgosedation WHAT: Occurrence, duration, and presumed cause of respiratory arrests or relevant respiratory depression, including classification of each apnoea episode according to the study-specific AIRS score (Airway Intervention and Respiratory Support Score; levels 0–4: 0 = brief, self-limiting, no intervention; 1 = simple stimulation sufficient, e.g. chin lift or verbal prompt; 2 = firm stimulus required, e.g. jaw thrust, or apnoea duration > 60 seconds; 3 = no response to firm stimulus and/or mask ventilation required; 4 = ventilation via supraglottic airway or further escalation required); number of apnoea episodes per AIRS level; effectiveness of standardised respiratory support and respiratory measures (chin lift, verbal instruction to breathe, jaw thrust, oral airway, mask ventilation, and early inhaled salbutamol administration in cases of known risk or clinical suspicion of an emerging bronchospastic reaction following a pronou

—

Countries

Germany

Contacts

Public ContactKonstantinos Raymondos

Medizinische Hochschule Hannover

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

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 11, 2026