Conventional vs. Video-Assisted Laryngoscopy for Perioperative Endotracheal Intubation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,855
- 试验地点
- 1
- 主要终点
- Successful intubation
研究概览
简要总结
COVALENT is a randomized, controlled, multi-center study that aims to evaluate the clinical routine practice of endotracheal intubation in an operative setting comparing video-assisted laryngoscopy to direct laryngoscopy.
详细描述
Data on the routine use of video-assisted laryngoscopy in peri-operative intubations are rather inconsistent and ambiguous, in part due to small study populations and non-uniform outcome measures in past trials. Failed or prolonged intubation procedures are a reason for relevant morbidity and mortality. This study aims to determine whether video-assisted laryngoscopy (irrespective of the shape of the blade) is non-inferior to the standard method of direct laryngoscopy with respect to the first-pass success rate. Furthermore, validated tools from the field of human factors will be applied to examine within-team communication and task load during this critical medical procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Patients and data analysts will be blinded regarding the assignment of interventions.
The randomization result will be communicated to the care providers non-verbally without revealing the result to the patient. Before data evaluation, the identifying variables will be made illegible. Investigators and care providers carrying out the intervention cannot be blinded due to the nature of the study. In the follow-up period two hours after the end of anesthesia, the outcome survey should be performed, if possible, by an investigator who was not involved in the intervention to ensure blinding. It will be documented whether blinding could be accomplished at this point. Un-blinding of the patient is only intended if an unexpected difficult airway situation occurred and the patient is issued a personal anaesthesia problem card. However, even in such cases, blinding can usually be ensured until after the last study visit.
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
- •Adult, legally competent patients
- •Scheduled for elective, non-cardiac surgical procedure
- •Need for endotracheal intubation as determined during the premedication visit
- •Informed consent
- •Care providers performing the intubation have at least one year of training in anesthesiology and experience in the use of VAL
排除标准
- •Lack of ability to give consent
- •Previous participation in this study
- •Pregnancy
- •Need for fiberoptic intubation
- •Patients scheduled for bariatric surgery
- •Any circumstance that will lead the anesthesiologist(s) in charge to believe that random assignment of a laryngoscopy instrument may compromise patient safety during induction of anesthesia
研究组 & 干预措施
CDL
Conventional direct laryngoscopy using a Macintosh blade
干预措施: Conventional direct laryngoscopy (CDL) (Procedure)
M-VAL
Video assisted laryngoscopy with a Macintosh-shaped blade
干预措施: Video assisted laryngoscopy with Macintosh-shaped blade (M-VAL) (Procedure)
H-VAL
Video assisted laryngoscopy with a hyper-angulated blade
干预措施: Video assisted laryngoscopy with hyper-angulated blade (H-VAL) (Procedure)
结局指标
主要结局
Successful intubation
时间窗: During the period of intubation (as soon as the laryngoscope blade passes the teeth row of the patient until the first capnographic end-expiratory carbon dioxide [CO2] detection is possible)
The primary endpoint is the successful intubation at first attempt as a dichotomous (successful/unsuccessful) event. The first attempt begins with the laryngoscope spatula passing the patient's row of teeth. The attempt is considered unsuccessful if a complete retraction of the laryngoscope or the endotracheal tube from the oropharynx is necessary for any reason (need for bag ventilation, change of device, change of patient position, change in the curvature of the stylet, etc.). Maneuvers that can be performed during laryngoscopy, such as BURP (backward, upward, rightward pressure) or reclining the head, which end with successful intubation, count towards the first attempt.
次要结局
- Parameters regarding the duration of the intervention(During the period of intubation (as soon as the laryngoscope blade passes the teeth row of the patient until the first capnographic end-expiratory CO2 detection is possible))
- Influence of the device on human factors during the intervention(During the period of intubation and maintenance of anesthesia)
- Cormack & Lehane grade(During the period of intubation (as soon as the laryngoscope blade passes the teeth row of the patient until the first capnographic end-expiratory CO2 detection is possible))
- Post-operative sore throat, coughing or hoarseness(End of surgery until two hours after the end of surgery)
- Intubation success(During the period of intubation (as soon as the laryngoscope blade passes the teeth row of the patient for the first time until the first capnographic end-expiratory CO2 detection is possible))
- Complications: occurrence of one or more of the following(During the period of intubation (as soon as the laryngoscope blade passes the teeth row of the patient for the first time until the first capnographic end-expiratory CO2 detection is possible))
- Need for auxiliary devices or switch of laryngoscopy device(During the period of intubation (as soon as the laryngoscope blade passes the teeth row of the patient for the first time until the first capnographic end-expiratory CO2 detection is possible))
- Relevant vital parameters during the intervention(During the period of intubation (as soon as the laryngoscope blade passes the teeth row of the patient for the first time until the first capnographic end-expiratory CO2 detection is possible))