Comparison Between C-MAC© Videolaryngoscope D-Blade Versus C-MAC© Videolaryngoscope Macin-tosh for Nasal Intubation. A Prospective Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- The incidence of adjunct maneuvers for nasal intubation.
研究概览
简要总结
This study compares two videolaryngoscope blade designs for nasal tracheal intubation in patients undergoing surgery under general anesthesia. Participants will be randomly assigned to undergo nasal tracheal intubation using either a hyperangulated C-MAC® D-BLADE® or a Macintosh-style videolaryngoscope blade.
The study will evaluate the effectiveness of each approach by measuring time to successful intubation, number of intubation attempts, airway maneuvers required, and other procedural outcomes. Safety outcomes, including airway- and anesthesia-related adverse events, will also be assessed. The findings may help identify the most effective and safe videolaryngoscope blade design for nasal tracheal intubation.
详细描述
ASIGN is a prospective, single-blinded randomized single-center study to be conducted at Mount Sinai Hospital comparing hyperangulated blades versus Macintosh style videolaryngoscope blades for nasal intuba-tion The study will aim to enroll 220 patients, 110 on each treatment arm.
Patients who meet the inclusion criteria will be identified on the day of surgery and consent will be ob-tained from these patients. Once eligibility is confirmed, the research coordinator will randomize the pa-tient to one of two groups: C-MAC© Videolaryngoscope D-Blade or the C-MAC© Videolaryngoscope Mac-intosh blade.
All study participants will receive the same perioperative management which will include nasal vasoconstriction with xylometazoline 0.05% nasal spray. Three sprays will be given in each nostril prior to the patient entering the operating room. The choice of nostril for the nasal intubation will be made according to the pre-assessment with the patient and radiology imaging available.
To minimize the risk of operator-related bias during the procedure, the data collection will be collected by a member of the research team. All intubations will be performed by an anesthesiologist with more than 3 years of experience in using Macintosh videolaryngoscope, hyperangulated videolaryngoscope, nasal intubation and adjunct maneuvers.
Standard monitoring of vital signs will be used, including non-invasive blood pressure, pulse oxygen saturation, cardioscope, end-tidal carbon dioxide waveform, and neuromuscular transmission (NMT). Additional monitoring will be left to the criteria of the attending anesthesiologist. All subjects will be preoxygenated to an end-tidal oxygen fraction above 80%. The head will be supported in a headgel pillow in the extended position in a way that the patient is comfortable prior to the induction and head elevation between 5 to 10 cm.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1. Patients 18 years old or above
排除标准
- •Patients requiring awake fiber optic intubation
- •Emergency cases
- •High risk of aspiration
- •Bleeding diathesis
- •Abnormal nasal anatomy
- •Chronic Epistaxis
- •Severe cardiorespiratory disease
- •Basilar skull fracture
研究组 & 干预措施
C-MAC© Videolaryngoscope D-Blade
Participants randomized to this arm will undergo nasal tracheal intubation using the C-MAC® Videolaryngoscope D-BLADE®, a hyperangulated videolaryngoscope blade. The assigned device will be used for the initial study intubation attempt following induction of general anesthesia. Intubation will be performed according to the study protocol, with procedural outcomes including time to successful intubation, number of attempts, and airway maneuvers recorded
干预措施: C-MAC® Videolaryngoscope D-BLADE® (Device)
C-MAC© Videolaryngoscope Macintosh
Participants randomized to this arm will undergo nasal tracheal intubation using a C-MAC® Videolaryngoscope with a Macintosh-style blade (size 3 or size 4, as clinically appropriate). The assigned device will be used for the initial study intubation attempt following induction of general anesthesia. Intubation will be performed according to the study protocol, with procedural outcomes including time to successful intubation, number of attempts, and airway maneuvers recorded.
干预措施: C-MAC® Videolaryngoscope Macintosh Blade (Device)
结局指标
主要结局
The incidence of adjunct maneuvers for nasal intubation.
时间窗: Day 0 (surgery day), during the intubation procedure on the day of surgery
Time from insertion of the videolaryngoscope blade into the mouth to confirmation of successful tracheal intubation by three consecutive end-tidal carbon dioxide waveforms.
次要结局
- Total time for intubation(Day 0 (surgery day), during the intubation procedure on the day of surgery)
- Number of adjunct maneuvers required for successful nasal intubation(Day 0 (surgery day), during the intubation procedure on the day of surgery)
- Total number of intubation attempts(Day 0 (surgery day), during the intubation procedure on the day of surgery)
- First-pass success rate(Day 0 (surgery day), during the intubation procedure on the day of surgery)