Sonographic Assessment of Cricoid Pressure
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Change in esophagus outer diameter following cricoid pressure
研究概览
简要总结
Examining the effectiveness of cricoid pressure using ultrasound imaging. Pulmonary aspiration of gastric contents during tracheal intubation, although rare in pediatrics, is a potentially catastrophic complication of anesthesia. Cricoid pressure is applied during rapid sequence induction to occlude the esophagus and prevent aspiration of gastric contents. Accumulating evidence in adults suggests that cricoid pressure often is not effective, either because the esophagus normally lies lateral to the cricoid cartilage, or because downward pressure on the cricoid cartilage laterally displaces (rather than compresses) the esophagus. The investigator proposes to examine the effectiveness of cricoid pressure in children in the peri-operative setting using non-invasive ultrasound imaging. Using this approach, the investigator will investigate the normal anatomical relationship of the esophagus and the cricoid cartilage, as well as how cricoid pressures influences this relationship. Further, the investigator will examine whether alternatives to downward cricoid pressure, such as laterally directed pressure, are more effective at occluding the esophagus.
详细描述
D. Design and methods
- Study design This study is interventional study of intubated or sedated children who are in the operating room or admitted to the MSICU (Medical Surgical Intensive Care Unit). The intervention is the application of cricoid pressure and also left lateral paratracheal pressure. The outer diameter and position of the esophagus will be assessed sonographically before and after the intervention is performed. Patients and families will be recruited in person either in the pre-op clinic or in the MSICU.
- Patient selection and inclusion/exclusion criteria All patients age 0 - 17 years who are on the OR (operating room) schedule and all patients admitted to the MSICU will be screened for this study. Patients in the MSICU will only be included if they are sedated as part of their clinical management.
Exclusion criteria: 1) history of airway or esophageal malformations (e.g. esophageal atresia or trachea-esophageal fistula) or who have had prior surgical procedures involving the airway or esophagus, 2) known difficult airways, 3) patients with tenuous artificial airways as determined by reviewing the CXR (chest x-ray), 4) patients with abnormal blood flow pattern to the head (e.g. history of right carotid ligation or interruption, known incomplete circle of Willis, known right IJ venous clots or obstruction, 5) patients with left neck CVLs (central venous line), and 6) patients with compromised skin integrity on neck. 3. Description of study treatments or exposures/predictors
The primary physician/surgeon for each patient will be approached for permission to approach the family for consent.
For operative patients, the study intervention will be performed following completion of the procedure when the patient is emerging from anesthesia. This is a period of time that often lasts 10s of minutes, has very good pain control, and is asleep. Scanning will be performed when the patient is intubated, to identify landmarks, and then as soon as the patient has been extubated to assess for the effect of cricoid or paratracheal pressure. For patients in the MSICU, the study intervention will be performed on any sedated patient who fulfills inclusion and exclusion criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients age 0 - 17 years who are on the OR (operating room) schedule and all patients admitted to the MSICU (Medical Surgical Intensive Care Unit) will be screened for this study.
- •Patients in the MSICU will only be included if they are sedated as part of their clinical management.
排除标准
- •history of airway or esophageal malformations (e.g. esophageal atresia or trachea-esophageal fistula) or who have had prior surgical procedures involving the airway or esophagus
- •known difficult airways
- •patients with tenuous artificial airways as determined by reviewing the CXR (chest x-ray)
- •patients with abnormal blood flow pattern to the head (e.g. history of right carotid ligation or interruption, known incomplete circle of Willis, known right IJ (internal jugular) venous clots or obstruction
- •patients with left neck CVLs (Central Venous Line)
- •patients with compromised skin integrity on neck
研究组 & 干预措施
Intervention/Control
Each subject will serve as their own control. The esophagus diameter will be measured on each subject, then cricoid pressure will be applied and the esophagus diameter will again be measured.
干预措施: Application of cricoid pressure (Other)
Intervention/Control
Each subject will serve as their own control. The esophagus diameter will be measured on each subject, then cricoid pressure will be applied and the esophagus diameter will again be measured.
干预措施: Application of Left lateral paratracheal pressure (Other)
结局指标
主要结局
Change in esophagus outer diameter following cricoid pressure
时间窗: 20 minutes
1. To sonographically assess the diameter of the esophagus before and after application of conventional cricoid pressure 2. To sonographically asses the diameter of the esophagus before and after application of left lateral paralaryngeal pressure
次要结局
未报告次要终点
研究者
David Kantor
Critical Care Physician
Boston Children's Hospital