Isolite and Dental Treatment Under Conscious Sedation: a Pilot Study to Assess the Upper Airway in a Pediatric Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Isolite and Dental Treatment Under Conscious Sedation
研究概览
简要总结
Hypothesis
The use of Isolite® system does not produce upper airway obstruction in the pediatric population during dental treatment with conscious sedation.
Purpose:
Report the changes in airway patency and pediatric patient's behavior when Isolite® system is used for dental treatment with conscious sedation.
Objectives:
- Determine changes in pulse rate
- Determine changes in SpO2
- Recognize breath sound's changes possibly associated with airway blockage
- Evaluate if the isolite® system is well tolerate by the pediatric population for dental treatment under conscious sedation
- Relate the use of Isolite® with the frequency of head reposition to open the airway.
详细描述
Report the changes in airway patency and pediatric patient's behavior when Isolite® system is used for dental treatment with conscious sedation.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 4 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ASA I (no systemic disease), ASA II (mid systemic disease-well controlled)
- •4-7 years of age
- •Patients English and Spanish speaking
排除标准
- •Upper airway infection
- •Craniofacial anomalies
结局指标
主要结局
Isolite and Dental Treatment Under Conscious Sedation
时间窗: 120 minutes (sedation appointment time)
In this study all patients were Mallampati 1 and Brodsky 2. The device comes in 4 sizes: pedo, small, medium and large. The most commonly used was pedo 65% (13) and small 35% (7). Eighty percent (16) of sedations had a satisfactory experience with Isolite ®, Twenty percent (4) had unsatisfactory outcome due to disruptive behavior. Of these 4 cases 2 patients were medicated with meperidine + hydroxyzine and the other 2 with midazolam. Fifty percent (8) of the patients successfully treated with Isolite ® experienced snoring and head reposition was performed to open airway. The level of sedation according to the AAPD guidelines was moderate in these events in which snoring occurred. The concentration of nitrous oxide-oxygen was adjusted so that more oxygen was given and the patient would be more alert. No significant changes in SpO2 (mean 99.8) or pulse were observed (mean 90.6).
次要结局
- Isolite and Dental Treatment Under Conscious Sedation(120 minutes (sedation appointment))
研究者
Claudia Isabel Contreras
Professor
The University of Texas Health Science Center at San Antonio