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临床试验/NCT03141515
NCT03141515已完成不适用

Sonographic Assessment of Postural Lung Recruitment in Pediatric Patients Under General Anesthesia

Hospital Privado de Comunidad de Mar del Plata2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年5月15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
40
试验地点
2
主要终点
Lung aeration

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. The collapse of dependent lung zones starts with anesthesia induction but can persist for hours or even days after surgery.

Lung collapse is a pressure-dependent phenomenon. Each acinus has a critical closing pressure, i.e., the minimum transpulmonary pressure (Ptp) below that the acinus begins to collapse. While airway pressure is homogeneously distributed within all lung units, Pleural pressure increases along the vertical gravitational vector because of the lung's weight. As a consequence, the decreased Ptp in the dependent zones promotes collapse. This means that patients in the supine position suffer from increasing closing pressures in the ventral to dorsal direction.

Alveolar recruitment maneuvers recruit collapsed alveoli, increase gas exchange, and improve arterial oxygenation.

The investigators hypothesized that in children with anesthesia-induced atelectasis, postural changes have recruiting effects and improve lung aeration assessed by lung ultrasound.

详细描述

Compare lung aeration between two different lung recruitment strategies (recruitment maneuvers in supine position and recruitment maneuvers with postural changes of lateral decubitus with 10 cmH2O level of positive-end expiratory pressure (PEEP) during 180 seconds; 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 5 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 5 years old
  • Scheduled for surgery under general anesthesia with tracheal intubation with atelectasis assessed by lung ultrasound after anesthesia induction.
  • 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

Active Comparator

After anesthesia induction patients received lung recruitment maneuver using pressure-control ventilation with a patient in supine position with 10 cmH2O level of positive end-expiratory pressure PEEP during 180 seconds. Lung ultrasound examination will be performed at two different times-point immediately after induction and after recruitment maneuver to monitor lung aeration.

干预措施: Lung ultrasound (Device)

Recruitment maneuver group

Experimental

Patients received lung recruitment maneuver with postural changes of lateral decubitus using pressure-control ventilation, 10 cmH2O level of PEEP in left and in right lateral decubitus during 90 seconds in each one. Lung ultrasound examination will be performed at two different times-point immediately after induction and after recruitment maneuver to monitor lung aeration.

干预措施: Lung ultrasound (Device)

结局指标

主要结局

Lung aeration

时间窗: Intraoperative

Compare lung aeration between two different lung recruitment strategies (recruitment maneuvers in supine position with 10 cmH2O level of PEEP during 180 seconds and recruitment maneuvers with postural changes of lateral decubitus: 10 cmH2O level of PEEP in left and in right lateral decubitus during 90 seconds in each one) 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

  • Peripheral arterial oxygenation by pulse oximetry (SPO2%)(Intraoperative)
  • Respiratory mechanics(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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