Evaluation of Gastric Insufflation with and without an inserted gastric tube in Thermoelastic cuff supraglottic devices: A Randomised Controlled Crossover 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
- 主要终点
- Incidence of gastric insufflation with and without an inserted gastric tube during incremental peak airway pressure trial (PAP)in thermoelastic cuff supraglottic devices.
研究概览
简要总结
Second Generation Supraglottic devices (SGD’s) are commonly used nowadays. They are considered superior to first generation devices due to higher oropharyngeal leak pressure, higher hypopharyngeal leak pressure and improved placement success. An additional lumen provides a mean for inserting a gastric tube as it is assumed that the risk of aspiration could be reduced by gastric drainage via such tube. Inserted gastric tube ensures proper positioning of SGD’s and hence reduce gastric insufflation. By contrast an open gastric channel venting air from the upper esophagus could protect against gastric insufflation. Gastric insufflation plays a key role in the pathophysiology of aspiration which can be carefully stimulated and detected reliably with gastric ultrasound. In our study we aim to evaluate and compare gastric insufflation with and without an inserted gastric tube though the available thermoelastic cuff supraglottic devices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •American Society of Anesthesiologists(ASA) Physical Status 1,2,3.
排除标准
- •1.Gastroesophageal reflux disease 2.Previous surgery on the upper gastrointestinal tract 3.Uncontrolled diabetes, severe pulmonary, end stage kidney or neurodegenerative diseases 4.Known airway diseases or anticipated difficult airway 5.Pregnancy 6.BMI more than or equal to 35 kg/m2.
结局指标
主要结局
Incidence of gastric insufflation with and without an inserted gastric tube during incremental peak airway pressure trial (PAP)in thermoelastic cuff supraglottic devices.
时间窗: 1. Pre operatively (baseline) | 2. Before start of first incremental positive airway pressure trial (approximately 8-10 mins after entering the operation theatre) | 3. After completion of first incremental positive airway pressure trial | 4. Before start of second incremental positive airway pressure trial | 5. After completion of second incremental positive airway pressure trial
次要结局
- change in cross sectional area of gastric antrum during the incremental peak airway pressure trial.(1. Pre operatively (baseline))
- Mean oropharyngeal leak pressure with & without an inserted gastric tube.(After completion of second incremental positive airway pressure trial)
- subjective ease of insertion of thermoelastic cuff supraglottic devices.(After insertion of thermoelastic cuff supraglottic devices)
- first attempt insertion success rate of thermoelastic cuff supraglottic devices.(After first attempt of insertion of thermoelastic cuff supraglottic devices)
- subjective ease of gastric tube insertion(After insertion of gastric tube)
- complications like post operative nausea & vomiting (PONV), pharyngeal discomfort, blood staining of the device, if any(at the end of stay in Post Anesthesia Care Unit & One week after surgery)
研究者
DrThrisha Sajeeth
Maulana Azad Medical College