Practicability of Airway Management With the Videolaryngoscopes I-scoop and C-Mac D-Blade Under Spontaneous Breathing and Analgosedation - A Prospective, Randomized, Monocentric Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
研究概览
简要总结
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
详细描述
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:
- Videolaryngoscopy: a less invasive laryngoscopy permits lighter sedation and preserves spontaneous breathing.
- Topical airway anesthesia: reliable suppression of airway reflexes reduces the need for deep sedation.
- Analgosedation: lower-dose, well-titrated sedation preserves spontaneous breathing and protective reflexes longer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: Airway management under spontaneous breathing with the i-scoop videolaryngoscope (Procedure)
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
干预措施: Airway management under spontaneous breathing with the C-Mac D-Blade videolaryngoscope (Procedure)
研究者
Raymondos, Konstantinos Prof. Dr.
Senior Consultant, Department of Anesthesiology and Intensive Care Medicine
Hannover Medical School