HyperANGulated Versus Macintosh styLE blaDes for INtubation in OBstetric Patients: a Cluster Randomized Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
研究概览
简要总结
Cesarean section under general anesthesia requires intubation (insertion of a tube through the mouth into the breathing pipe to support breathing during the surgery). A device called a video laryngoscope is used, which has a smooth, curved, or less curved component called 'a blade' that helps the doctor gently see the voice box and guide the breathing tube safely into place during anesthesia; it is not a sharp tool blade.
There are two types of video laryngoscopes blades: a Macintosh- style blade with a gentle curve, approximately 90 degrees) and a hyperangulated blade (with a more pronounced curve).
Although video laryngoscopes are safe and both types have been used for around 20 years, it is not known whether one type works better that the other in patients undergoing cesarean delivery under general anesthesia. Because general anesthesia is used in only a small proportion (about 5%) of all cesarean deliveries, research in this area is limited.
The main purpose of the study is to assess if a study comparing these two types of blades in the obstetric population is feasible. This is also known as a feasibility study, which aims to test the study plan and determine whether enough participants will join a larger study and accept the study procedures. The results will be used as a guide for a larger study.
详细描述
Study design and setting.
This will be a single-site, prospective feasibility study conducted within the Department of Anesthesia and Pain management, Mount Sinai Hospital, Toronto, a high-volume tertiary obstetric centre with established expertise in obstetric anesthesia and airway research.
Intervention and Cluster Assignment
Because individual randomization immediately before induction is often impractical in obstetric emergencies, blade assignment will occur by randomized time-based clusters. Randomization will occur in 4 clusters of 4 months each, separated by one-month washout periods. Four consecutive four-month periods will be randomly assigned to use either a hyperangulated or Macintosh-style blade as the default for the first intubation attempt. Clinicians may deviate from the assigned blade for patient safety. The time-block design minimizes contamination associated with rapid decision-making in obstetric emergencies and aligns with real-world workflow on labour and delivery units.
Randomization
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)
盲法说明
The statistician, responsible for randomization, will remain blinded to outcome data during data collection and will perform the prespecified statistical analyses after database lock.
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •1. Pregnant patients undergoing emergency or urgent cesarean delivery under general anesthesia requiring tracheal intubation.
排除标准
- •No tracheal intubation performed and (ii) patient refusal of consent.
- •Patients not receiving general anesthesia.
- •Patients that previously participated in the study.