Effect of Sedation on Pulmonary Aeration in Children
试验速览
- 阶段
- 不适用
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Changes in the Lung Ultrasound Score in children undergoing deep sedation
研究概览
简要总结
Pediatric sedation is an anesthesiological technique with a good safety profile, but various complications might ensure, especially from the respiratory point of view. No suggestion is available about a possible upper safety limit for the duration of sedation to limit respiratory issue. In order to address this topic, the investigators concentrated on the occurrence of hypoventilated lung areas, which is a well-known side effect of anesthesia and sedation. The investigators hypothesis that the length of sedation is correlated with the occurrence of lung atelectasis and hypoventilation. To assess lung hypoventilation the lung ultrasound will be used. Lung ultrasound will be performed immediately after the induction of sedation and immediately before sedation interruption, in children scheduled for magnetic resonance exams.
The study is a prospective observational study
详细描述
Worldwide, an increasing number of medical procedures are performer in children under sedation in many different clinical settings, in compromised patients, often outside the operating theater and often by non-anesthesiologists.
Although a good safety profile accounts for the spread of sedation, various complications might ensure. Furthermore of all the patients receiving sedation for diagnostic and therapeutic procedures, the pediatric population is the subgroup at the highest risk level and with the lowest tolerance of error.
In the last years the results of two large database studies have been published to lend some clarity on the rate and nature of adverse events involving sedation/anesthesia outside the operating room. Respiratory complications were the most frequently reported, and required critical anesthesiological competencies for a correct management to avoid poor outcomes.
Risk factors for adverse events during sedation/anesthesia have been evaluated by the 2016 SIAARTI(Società Italiana di Anestesia, Analgesia, Rianimazione e Terapia Intensiva)-SARNePI (Società di Anestesia e Rianimazione Neonatale e Pediatrica Italiana) guidelines for the standard of pediatric anesthesia, including patients' age, ASA (American Society of Anesthesiology) class, experience of the operators, and urgency/emergency conditions.
On the other hand, no suggestion is available either in current literature or guidelines, about a possible upper safety limit for the duration of sedation. In order to address this topic, the investigators concentrated on the occurrence of hypoventilated lung areas, which is a well-known side effect of anesthesia and sedation. To assess lung hypoventilation the LUSS-Lung Ultrasound Score will be used, since it is a validated and non invasive tool.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
入排标准
- 年龄范围
- 1 Year 至 8 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children 1-8 years old (included)
- •Informed consent of both parents
- •Scheduled for elective cerebral or medullary Magnetic Resonance exam
排除标准
- •Any ongoing respiratory disease
- •Contraindications to the use of propofol
- •LUSS ≤12 at the first US assessment (a baseline maximum score 1 on all of the pulmonary fields)
- •need for mechanical ventilation
结局指标
主要结局
Changes in the Lung Ultrasound Score in children undergoing deep sedation
时间窗: through study completion, an average of 1 hour
Lung ultrasound score
次要结局
- Incidence of any respiratory and non-respiratory adverse event in children undergoing deep sedation(through study completion, an average of 1 hour)
- Effect of sedation length on hypoventilation in children undergoing deep sedation(through study completion, an average of 1 hour)
研究者
Marco Gemma
Principal Investigator
IRCCS San Raffaele
