Nasotracheal Intubation With Videolaryngoscopy Versus Direct Laryngoscopy in Infants (NasoVISI) Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 680
- 试验地点
- 16
- 主要终点
- VL first attempt success rate
研究概览
简要总结
Nasotracheal Intubation with Videolaryngoscopy versus Direct Laryngoscopy in Infants (NasoVISI) Trial is a prospective randomized multicenter study. The study will be conducted at 8 centers in the United States. It is expected that approximately 700 subjects enrolled to product 670 evaluable subjects.The randomization is 1:1 naso tracheal intubation with the Storz C-Mac Video Videolaryngoscopy (VL) or the Standard Direct Laryngoscope (DL). The primary objective is to compare the nasotracheal intubation (NTI) first attempt success rate using VL vs. DL in infants 0-365 days of age presenting for cardiothoracic surgery and cardiac catheterizations.
详细描述
The primary objectives of the study are to compare the nasotracheal intubation (NTI) first attempt success rate using VL vs. DL in infants 0-365 days of age presenting for cardiothoracic surgery and cardiac catheterizations.
Secondary Objectives include the number of attempts for successful intubation; Incidence of failed NTI (conversion to oral intubation); Incidence of failure to intubate with assigned device; Incidence of complications over all attempts including non-severe and severe complications; Incidence of 1st-attempt complications; Need for cricoid pressure or external laryngeal manipulation, need for adjunct- (Magill forceps), rescue of one technique of the other, Percent of glottic opening (POGO) score less than 100%, intubation sequence exceeding 60 seconds and interaction analysis of weight group (i.e. ≤ median weight & > median weight (kg)), and by clinicians' experience with cardiac anesthesiology (i.e. Permanent full time team members & rotating team members) on the association between treatment and outcomes
Study Design: this is a prospective, randomized, multi-center parallel group trial
Setting/Participants: This will be a multi-center study. The target population will be infants 0-365 days of age scheduled for elective cardiothoracic surgery or cardiac catheterization requiring general anesthesia with NTI.
Study Interventions and Measures: The study intervention will be a 1:1 randomization to perform tracheal intubation with the Storz C-Mac Video Videolaryngoscopy (VL) or the Standard Direct Laryngoscope (DL).
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
Blinding of the device for clinicians and study staff is not feasible in this study. Participants will be blinded. The statisticians will be blinded at the time of generating the randomization schedule and remain blinded at the time of analysis.
入排标准
- 年龄范围
- 1 Day 至 365 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females age 0 -365 days
- •Scheduled for elective cardiothoracic surgery or cardiac catheterization procedures lasting longer than 30 minutes under general anesthesia where nasotracheal intubation will be performed by an anesthesiology clinician
- •Plan to use a neuromuscular blocking drug prior to intubation as standard of care
- •Parental/guardian permission (informed consent)
- •For clinician participants:
- •Anesthesia attending, anesthesia fellows, anesthesia resident, Anesthesia Assistant (AA) or CRNA
排除标准
- •Less than 36 weeks gestation
- •Less than 2 kg
- •History of difficult intubation
- •History of abnormal airway
- •Predictive of difficult intubation upon physical examination
- •Preoperative endotracheal tube or tracheostomy
- •Emergency cases
结局指标
主要结局
VL first attempt success rate
时间窗: 24 hours
Direct observation of intubation in the OR and medical record review
次要结局
- Number of attempts for successful intubation(24 hours)
- Incidence of failed NTI (conversion to oral intubation)(24 hours)
- Interaction analysis of weight group and by clinicians' experience with cardiac anesthesiology on the association between treatment and outcomes(24 hours)
- Incidence of additional techniques(24 hours)
- Incidence of failure to intubate with assigned device(24 hours)
- Incidence of complications over all attempts including non-severe and severe complications(24 hours)
- Incidence of 1st-attempt complications(24 hours)