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临床试验/NCT03461770
NCT03461770已完成不适用

Continuous Positive Airway Pressure Decreased Lung Collapse During General Anesthesia Induction in Pediatric Patients

Hospital Privado de Comunidad de Mar del Plata2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2018年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
42
试验地点
2
主要终点
Lung aeration during anesthesia

研究概览

简要总结

Anesthesia-induced atelectasis is a well-known entity observed in approximately 68-100% of pediatric patients undergoing general anesthesia. Infants and young children are more susceptible to this lung collapse due to their small functional residual capacity. Thus, intrapulmonary shunting caused by those atelectasis are more likely to occur during general anesthesia in infants and younger children than in adults. This problem predisposes children to hypoxemic episodes that can persist in the early postoperative period. Beyond the negative impact of atelectasis on gas exchange, mechanical ventilation induces a local inflammatory response in atelectatic lungs, even in healthy patients undergoing general anesthesia.

Therefore, the diagnosis, prevention and active treatment of anesthesia-induced atelectasis are mandatory, not only to avoid hypoxemic episodes and atelectasis-related post-operative pulmonary complications, but also to protect the lungs during mechanical ventilation. Nowadays, the diagnosis of anesthesia-induced atelectasis is easily and accurately accomplished by lung ultrasound (LUS). LUS is a simple and non-invasive tool useful to detect atelectasis in children, to assess lung aeration and for monitoring ventilator settings or strategies. Regarding to the prevention of atelectasis, it was demonstrated that the application of continuous positive airway pressure (CPAP) during the induction of general anesthesia decreases atelectasis formation in adult morbidly obese patients.

The investigators hypothesized that the use of CPAP during general anesthesia induction in pediatric patients can prevent or decrease atelectasis formation.

详细描述

Compare lung aeration between two different strategies of induction to general anesthesia: breathing throughout a facial mask without CPAP and breathing with 5 cmH20 of CPAP in pediatric patients scheduled for surgery under general anesthesia, using ultrasound imaging and a four-point-aeration score to assess the lung aeration.

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)

入排标准

年龄范围
6 Months 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Written informed consent by parents.
  • Patients aged 6 months to 7 years old
  • Scheduled for surgery under general anesthesia with tracheal intubation.
  • American Society of Anesthesiologists classification: physical status I-II

排除标准

  • Acute airway infection
  • Cardiovascular or pulmonary disease
  • Previous thoracic procedure

研究组 & 干预措施

Control group

No Intervention

Patients will receive anesthesia induction with Sevoflurane using a circular circuit without CPAP. Protective ventilation with 5 cmH20 of positive end-expiratory pressure (PEEP) will be initiated after induction. At the end of surgery, mechanical ventilation will stop allowing spontaneous ventilation. Patients will be extubated without CPAP. Lung ultrasound examinations will be performed at different times-points: before anesthesia induction, during surgery, at the end of surgery and before extubation, and after extubation.

CPAP group

Experimental

Patients will receive anesthesia induction using 5 cmH20 of CPAP until the moment of intubation. After induction patients will receive the same protective ventilation than the control group. A lung recruitment maneuver will be applied if these patients present atelectasis during surgery. At the end of surgery, patients will be extubated under the modality of CPAP with 5 cmH20. Lung ultrasound examinations will be performed at different times-points: before anesthesia induction, during surgery, at the end of surgery and before extubation, and after extubation.

干预措施: CPAP (Other)

结局指标

主要结局

Lung aeration during anesthesia

时间窗: intraoperative

Compare lung aeration between two different strategies of induction to general anesthesia: breathing throughout a facial mask without CPAP and breathing with 5 cmH20 of CPAP in pediatric patients scheduled for surgery under general anesthesia, using ultrasound imaging and a four-point-aeration score to assess the lung aeration (0 = normal lung, 1 = moderate aeration loss, 2 = severe aeration loss, 3 = complete aeration loss and consolidation).

次要结局

  • Lung aeration after surgery(immediately after surgery)
  • Peripheral arterial oxygenation by pulse oximetry(intraoperative)

研究者

发起方
Hospital Privado de Comunidad de Mar del Plata
申办方类型
Other
责任方
Sponsor

研究点 (2)

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