Video-laryngoscopic Visualization of the Intubation Pathway With the "IRRIS"-Device. A Clinical Safety and Proof of Concept Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Safety 1: Absence of skin lesions
研究概览
简要总结
A prospective, open label, non-randomized, single centre safety and feasibility study. Patients with no expected airway difficulties scheduled for elective surgery including tracheal intubation and general anesthesia procedures will be enrolled into the study. Following standard induction of anesthesia, the IRRIS will be attached to the patient's neck skin just beneath the laryngeal prominence (Adam's apple) and the intubation will be performed by using a video-laryngoscope in a standardized fashion. The IRRIS device emits a light that penetrates through the skin into the airway and that is visible on the video-laryngoscope display. This light highlights the right pathway for the tracheal tube and facilitates the visual recognition and identification of the laryngeal inlet. In case of problems identified during the induction period such as an unexpected difficult intubation situation and the IRRIS does not provide the expected facilitation of intubation, the local "unexpected difficult airway" protocol goes into effect.
详细描述
The IRRIS (InfraRed - Red Intubation System) is an external disposable light source in a patch that is intended for single use while it is placed externally on the patient's neck before tracheal intubation for the duration of tracheal intubation. The device transmits near-infrared light through the skin towards the trachea. During laryngoscopy, the emitted light becomes visible only from the trachea and not from the oesophagus. Video assisted devices which already are in the market known as video-laryngoscopes and fiberoptic bronchoscopes are capable of detecting and visualizing the emitted light so that the anaesthesiologist who is performing the intubation is aided to direct and insert the endotracheal tube into the trachea by following the light on the screen of his video-assisted endoscope. The objective of this study is to assess the safety, and performance of IRRIS in patients who undergo tracheal intubation in terms of skin integrity, duration of intubation, number of attempts, success of intubation and usability aspects in terms of subjective physician grading of the IRRIS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Male and female patients scheduled for elective surgery requiring general anesthesia and tracheal intubation.
- •Patient age: adult (>18 years old)
- •Mallampati scores 1 to
- •ASA Physical Status Classification System 1-3
- •Ability to understand the requirements of the study, willingness to comply with its instructions and schedules, and agreement to the informed consent
排除标准
- •Emergency cases
- •Expected airway difficulties as defined during the pre-anaesthesia visit
- •Necessity for an alternative airway management approach other than by using a video-laryngoscope
- •Rapid sequence induction
- •Skin disorders and skin light sensitivity (SLE, lupus, Porphyria, Dermatomyositis, Pemphigus, Pellagra etc.)
- •Known history of any significant medical disorder, which in the investigator's judgment contraindicates the patient's participation
- •Impaired head and neck mobility
- •Scars or skin injuries at the neck
研究组 & 干预措施
Study intervention group
All participants will be intubated with a video-laryngiscope by guiding the tracheal tube according to the highlighted Larynx on the Video Screen.
干预措施: IRRIS InfraRed - Red Intubation System (Device)
结局指标
主要结局
Safety 1: Absence of skin lesions
时间窗: 15 minutes after end of anesthesia
skin lesions, irritations after removal of the patch at the end of anesthesia (yes / no)
Safety 2: Severity of skin lesions
时间窗: 15 minutes after end of anesthesia
skin lesions, irritations after removal of the patch at the end of anesthesia (mild/moderate/severe)
次要结局
- Proof of Concept 4: Intubation success(5 minutes after start of intubation)
- Proof of Concept 5: Ease of use of IRRIS(5 minutes after start of intubation)
- Proof of Concept 8: Intubation success(5 minutes after start of intubation)
- Proof of Concept 7: Ease of use of IRRIS(5 minutes after start of intubation)
- Proof of Concept 2: Intubation success(5 minutes after start of intubation)
- Proof of Concept 3: Intubation success(5 minutes after start of intubation)