跳至主要内容
临床试验/NCT03392012
NCT03392012Unknown不适用

Effect of Sedation on Pulmonary Aeration in Children

IRCCS San Raffaele1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2018年2月6日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marco Gemma

Principal Investigator

IRCCS San Raffaele

研究点 (1)

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