Awake Video-bronchoscopic Tracheal Intubation for Prevention of pulmonary Aspiration associated with general anesthesia induction (AV-TIPA) - a clinical registry based real-world-evidence study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Success rate and safety of video-bronchoscopic
研究概览
简要总结
Imagine you or a loved one needs surgery under general anesthesia. During the procedure, a crucial step is placing a breathing tube into the windpipe to ensure you receive oxygen and can breathe safely throughout, till your recovery from general anesthesia. This process, called tracheal intubation, is the worldwide standard of care for major surgeries under general anesthesia. However, there’s a risk of stomach contents entering your lungs during this process, which can be dangerous and life-threatening. Fasting before surgery greatly reduces this risk. However, even with proper fasting before surgery, many patients are still at risk due to various underlying diseases. Patients requiring emergency surgery with a full stomach face the same risk. Our study aims to investigate a safer approach to tracheal intubation. We’re examining a method called video-bronchoscopic awake tracheal intubation. This technique involves using a small camera to guide tracheal tube placement while the patient is awake. Many anesthesiologists currently use this technique, but it’s not yet widely adopted for this scenario. By performing this procedure with the patient awake, under direct vision, without sedation, and after numbing the throat with a local anesthetic solution, we can eliminate the risk of stomach contents entering the lungs during intubation. Conducting an experimental study to compare this technique with the conventional one would be ethically problematic. We’ll analyze the real-world data of our Institute from past surgeries to measure the effectiveness, safety and feasibility of this approach in a medical team with diverse levels of experience. We shall assess any immediate or delayed complications recorded in the patient’s medical records related to the procedure or stomach contents entering the lungs under anesthesia. While participants won’t directly benefit from this study of existing medical records, the insights gained will contribute to safer surgeries under general anesthesia for patients at risk of aspiration during tracheal intubation. Patient privacy and confidentiality are our top priorities. Since we’re using existing medical records and not contacting patients for follow-up, we won’t need to obtain consent. We shall ensure that the information collected is used responsibly and securely, maintaining the privacy of patients’ clinical data.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •All adult patients in the existing registry of awake tracheal intubation under topical anesthesia, performed by an attending doctor in the situation of pulmonary aspiration risk during general anesthesia for elective or emergency surgery.
- •The procedure details recorded in the EMR of each such patient as a part of prevalent clinical practice, must match that in the clinical registry, for the case to be eligible for the study.
排除标准
- •Any patient who underwent the same or similar procedure, but not appearing in the aforesaid clinical registry; or there is mismatched data or missing data.
结局指标
主要结局
Success rate and safety of video-bronchoscopic
时间窗: Day 0 - Baseline (during the procedure) | Day 0 - Immediate postoperative period
awake tracheal intubation.
时间窗: Day 0 - Baseline (during the procedure) | Day 0 - Immediate postoperative period
次要结局
- The incidence of complications, & adverse events; types of devices used(for the procedure, & also the levels of experience of caregivers who performed and)
研究者
Prof Jyotirmay Kirtania
MPMMCC Tata Memorial Centre Varanasi
