跳至主要内容
临床试验/NCT06360328
NCT06360328招募中不适用

Success Rates of Video- vs. Direct Laryngoscopy for Endotracheal Intubation in Anesthesiology Residents: A Randomized Controlled Trial" (The JuniorDoc-VL-Trial)

University Hospital Heidelberg1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
1
主要终点
Rate of Successful tracheal intubation on the first attempt (First-Pass-Success).

研究概览

简要总结

Securing the airway through endotracheal intubation (ETI) is a fundamental skill for anaesthetists. It is used during surgery, in the intensive care unit, during periprocedural anaesthesia and in emergency medicine. The clinical relevance of airway management is demonstrated in particular by the fact that the main cause of serious anaesthesia-related complications lies in the area of airway management. increasing technological developments in recent years (e.g. video laryngoscopy [VL]) aim to reduce the complication rate in the area of airway management. however, there are currently a large number of VLs available, which differ massively in their application. Therefore, it is essential to systematically collect data and develop structured training in airway management, taking into account current technological developments.While endotracheal intubation is traditionally performed with a direct laryngoscope, indirect video laryngoscopy, with chip-based camera technology at its tip, has been introduced across the board in recent years and is now part of standard clinical and preclinical equipment. Doctors in advanced training are trained with a focus on direct laryngoscopy; the use of and training in indirect video laryngoscopy does not follow any standards; in addition, the decision as to which method of securing the airway is chosen has so far been the responsibility of the individual doctor in anaesthesiology, although there is a tendency for the VL to be associated with a higher success rate in the first intubation attempt, the so-called "first-pass success".The main aim of this clinical prospective, randomised controlled trial is to train anaesthetists in advanced training in conventional direct laryngoscopy on the one hand and indirect video laryngoscopy (VL) on the other, with a focus on tracking the progress of their skills after 200 intubations with regard to first-pass success.

详细描述

Securing the airway is a core competence of anaesthetists, intensive care physicians and emergency physicians, as oxygenation of the human organism is not possible without an open or secured airway. The introduction of new techniques and the implementation of guidelines and strategies for the care of the difficult airway have contributed significantly to a reduction in morbidity and mortality. Of particular importance are problems that can occur during airway management, which are referred to in anaesthesiology as the "difficult airway". The term "difficult airway" refers to problems that can occur during airway management. Despite technological advances in the field of airway management, such as the use of video laryngoscopes, the definition of a difficult airway is still based on the traditional methods of mask ventilation and intubation using direct laryngoscopy. In recent years, several airway management studies suggest that the primary use of video laryngoscopes in adult patients undergoing endotracheal intubation is associated with a reduction in failed attempts and complications such as hypoxaemia.Problems during endotracheal intubation are often subsumed under the term "difficult intubation" without differentiating between "laryngoscopy" and "endotracheal intubation". However, if indirect laryngoscopy techniques are used, such as videolaryngoscopic intubation, a clear distinction must be made between the two procedures, as the incidence of difficult laryngoscopy is always lower than that of difficult or impossible intubation. The incidence of difficult direct laryngoscopy is 1.5% to 8.0%, while the incidence of difficult intubation is slightly lower. A potentially life threatening unexpected "cannot intubate, cannot ventilate" situation has a probability of0.008% (1:13,000) to 0.004% (1:25,000). In a randomised study design, we would like to record resident anaesthesiologists (first-year) learning the skill of endotracheal intubation with direct and indirect laryngoscopy in order to derive and analyse anaesthesiological quality parameters, such as first-pass success and possible complications. The individual learning curves of those entering the profession will also be taken into account in order to gain insights for the improvement of training programmes and training methods in anaesthesiology.

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
Single (Participant)

盲法说明

Only the patient is blinded, as the participants (residents) cannot be blinded.

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

  • •First Year Anesthesiology Residents

排除标准

  • •Physicians' refusal to participate in the study
  • •Participants in another study

研究组 & 干预措施

direct Laryngoscopy

No Intervention

The resident intubates using direct laryngoscopy .

video Laryngoscopy

Experimental

The resident intubates using video laryngoscopy

干预措施: video laryngoscopy (Device)

结局指标

主要结局

Rate of Successful tracheal intubation on the first attempt (First-Pass-Success).

时间窗: Directly during intubation

Rate of Successful tracheal intubation on the first attempt (First-Pass-Success).

次要结局

  • When using VL, record the occurrence of fogging.(Directly during intubation)
  • Mention any failures or transitions to other rescue techniques.(Directly during intubation)
  • Specify the use of Optimal External Laryngeal Manipulation (OELM) techniques such as backward, upward and rightward pressure (BURP) Cricoid Pressure (CP) or adjustment of the participant's head and neck position.(Directly during intubation)
  • assess the glottic view using the Percentage of Glottic Opening Score (POGO) (0%-100%). (0%= no view, 100% best view)(Directly during intubation)
  • Specify the number of attempts made during laryngoscopy.(Directly during intubation)
  • Compare the level of training with intubation success.(During the analysis)
  • Assess the glottic view using the Cormack-Lehane-Score (I - IV). (I = good view)(Directly during intubation)
  • Number of complications such as desaturation below 90% Oxygen saturation level (SpO2), regurgitation, dental or soft tissue trauma.(Directly during intubation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. med. Davut Deniz Uzun

Medical Doctor, Post-Doc Researcher, Department of Anesthesiology

University Hospital Heidelberg

研究点 (1)

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