Videolaryngoscopy Versus Direct Laryngoscopy for Tracheal Intubation in Pediatric Surgery: The VIDEOKIDS Pragmatic Multicentre Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 5,562
- 试验地点
- 1
- 主要终点
- Number of intubations with successful tracheal intubation on the first attempt
研究概览
简要总结
Tracheal intubation in paediatric patients is a high-risk procedure in which failure to achieve successful intubation on the first attempt is associated with an increased risk of complications, including hypoxaemia and airway trauma. Videolaryngoscopes have been increasingly adopted in clinical practice because they improve glottic visualisation; however, evidence of their benefit in paediatric patients remains inconsistent.
The VIDEOKIDS trial is a large, pragmatic, international, multicentre, randomised controlled trial designed to compare videolaryngoscopy with direct laryngoscopy as the initial technique for tracheal intubation in paediatric patients undergoing surgery under general anaesthesia. The primary objective is to determine whether videolaryngoscopy increases the rate of successful intubation on the first attempt compared with direct laryngoscopy.
详细描述
The purpose of this prospective, international, multicentre, randomised controlled trial is to compare videolaryngoscopy with direct laryngoscopy as the initial technique for tracheal intubation in paediatric patients undergoing elective surgery under general anaesthesia. We hypothesise that videolaryngoscopy will increase the frequency of successful intubation on the first attempt compared with direct laryngoscopy.
Eligible patients aged 0 to 16 years requiring orotracheal intubation will be randomly assigned in a 1:1 ratio to videolaryngoscopy or direct laryngoscopy for the first intubation attempt. The specific device and blade type, as well as all aspects of peri-intubation management, including patient positioning, preoxygenation, and pharmacological agents, will be determined by the attending anaesthesiologist according to local practice.
The primary outcome is successful tracheal intubation on the first attempt. Secondary outcomes include time to intubation, number of intubation attempts, glottic visualisation, need for adjunct airway devices, and intubation-related complications.
The primary analysis will follow the intention-to-treat principle. A mixed-effects logistic regression model will be used to account for centre-level variability and prespecified clinically relevant covariates.
Current evidence in paediatric populations remains inconclusive, with recent meta-analyses showing no clear improvement in first-attempt success despite better glottic visualisation with videolaryngoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 0 Days 至 16 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Paediatric patients (age 0-16 years),
- •Undergoing elective or scheduled surgery under general anaesthesia requiring orotracheal intubation,
- •Planned tracheal intubation using either videolaryngoscopy or direct laryngoscopy as the initial technique,
- •Informed or general consent given, according to the relevant ethics committee statement,.
排除标准
- •Known upper airway anatomical abnormalities or clinical conditions requiring a specific intubation technique (e.g., fibreoptic intubation),
- •Requirement for emergent tracheal intubation that does not allow adequate randomisation,
- •Refusal of parents or legal guardians to participate in the study.
研究组 & 干预措施
Direct laryngoscope group
For patients assigned to the laryngoscope Group, the operator will use a Macintosh laryngoscope on the first laryngoscopy attempt.
干预措施: Direct Laryngoscope (Device)
Videolaryngoscope group
For patients assigned to the videolaryngoscope Group, the operator will use a video laryngoscope on the first laryngoscopy attempt.
干预措施: Videolaryngoscope (Device)
结局指标
主要结局
Number of intubations with successful tracheal intubation on the first attempt
时间窗: Duration of procedure of procedure (minutes)
The primary outcome is successful tracheal intubation on the first attempt, defined as placement of an endotracheal tube in the trachea following a single insertion of the laryngoscope blade into the mouth, without its removal.
次要结局
- Successful intubation(Duration of procedure (minutes))
- Incidence of "easy intubation"(Duration of procedure (minutes))
- Number of laryngoscopy attempts(Duration of procedure (minutes))
- Number of attempts to cannulate the trachea with a bougie or an endotracheal tube(Duration of procedure (minutes))
- Duration of tracheal intubation(Duration of procedure (minutes))
- Reason for failure to intubate on the first attempt(Duration of procedure (minutes))
- Operator-assessed difficulty of intubation(Duration of procedure (minutes))
- Glottic view assessed using the modified Cormack-Lehane classification(Duration of procedure (minutes))
- Glottic view assessed using the percentage of glottic opening (POGO score).(Duration of procedure (minutes))
- Need for additional airway equipment(Duration of procedure (minutes))
- Need to change the device for intubation(Duration of procedure (minutes))
研究者
Manuel Taboada Muñiz
Professor
Hospital Clinico Universitario de Santiago