Is End Tidal CO2 Level Elevation During Upper Endoscopy With CO2 Gas Insufflation Physiologically Significant
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Number of Procedures With Elevated End-tidal CO2 Levels
研究概览
简要总结
During the course of an endoscopic procedure, air has historically been used to inflate the lumen to provide adequate visualization and allow for the endoscope to advance as necessary. In many adult centers, carbon dioxide is used for insufflation for all procedures. Many pediatric centers have started using carbon dioxide for insufflation during endoscopy based on the adult studies. Few pediatric studies have been done. This study is designed to test whether carbon dioxide is associated with any negative, post-procedural, outcomes in pediatric patients.
详细描述
Luminal inflation is essential for adequate visualization and endoscope advancement during endoscopy. Although air has previously been the standard gas used, CO2 is increasing preferred in adult endoscopy centers, due to reports of decreased post-procedural abdominal discomfort compared to air. Few published studies in children demonstrated decreased abdominal discomfort with use of CO2, but safety concerns for its use in pediatric endoscopy remain.
This is a Double-blinded, prospective, randomized study of all pediatric patients undergoing procedures involving upper endoscopy in the Childrens Hospital & Medical Center. Randomization will be for patients undergoing upper endoscopy related procedures. Patients will be randomized 1:1 for air or CO2. Vital signs will be recorded before the procedure, throughout the procedure and after the procedure until fully awake. While in the procedure room, end-tidal CO2 level will be continuously recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
This is a double-blinded, prospective, randomized study
入排标准
- 年龄范围
- 6 Months 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children 6 months to 19 years old and
- •Undergoing upper endoscopy at Children's Hospital & Medical Center in Omaha, NE and
- •Parents or legal guardians consent to the study
排除标准
- •Patients and legal guardians who decline participation in the study
- •Patients with chronic respiratory disease (defined as severe asthma, bronchopulmonary dysplasia and cystic fibrosis-related pulmonary disease)
- •Patients with cyanotic heart disease
- •Patients with an ASA status of ≥
- •Patients who are wards of the state or in foster care
- •Prisoners
- •Patients undergoing colonoscopy only procedures or procedures not related to upper endoscopy
结局指标
主要结局
Number of Procedures With Elevated End-tidal CO2 Levels
时间窗: Measured from time of procedure start to time of procedure conclusion this lasts usually from 1-2.5 hours.
Compare the peak end-tidal CO2 levels (\>/= 60 mmHg) observed during endoscopy in children managed with endotracheal intubation or laryngeal mask airway using CO2 versus air
次要结局
- Number of Participants Reporting Abdominal Pain(This will be assessed before and after the procedure)