The Accuracy of Pediatric Air Test as a Non-invasive Atelectasis Diagnostic Tool: a Multi-centre Prospective Double-blind Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 4
- 主要终点
- Atelectasis incidence
研究概览
简要总结
HYPOTHESIS:
During anesthetic pre-oxygenation with high FiO2, pulmonary atelectasis occur, especially in patients < 6 years old, where FRC and pulmonary closing volume may overlap. New borns and children <1 year old are especially vulnerable.
OBJECTIVES:
- Validate "air test" as a individualized and non-invasive diagnostic method of clinically significant atelectasis in pediatrics.
- Determine what other factors contribute to atelectasis development in pediatrics
METHODS:
30 pediatric patients will be studied with ages ranged between 45 postconceptional weeks and16 years old.
Baseline SpO2 and lung ultrasound will be performed for each patient upon arrival at the operating theatre before preoxygenation with FiO2 of 1.0 SpO2 will be measured 15 min after intubation during a 5 min long "air test" trial (FiO2 0.25). lung collapse will be verified by lung ultrasound at the end of the 15 min trial. Lung collapse will be eventually granted upon lung US verification by a blind researcher.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
Lung Collapse will be diagnosed by a blind researcher that does not know the air test results
入排标准
- 年龄范围
- 5 Weeks 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •General anesthesia
- •Perioperative risk classification (ASA) I, II, III
- •Newborns (postconceptional age> 45 weeks) to 16 years
- •Need for oral / nasotracheal intubation
排除标准
- •ASA > III
- •Basal SpO2 < 97% on air in supine position
- •Preoperative need for oxygen therapy and / or high-flow nasal cannulas
- •Expected Difficult airway
- •Presence of craniofacial disorders that may compromise ventilation
- •Hemodynamic instability and / or need for inotropics
- •History of untreated heart disease
- •Presence or history of pneumothorax
- •Presence of untreated congenital pulmonary disorders
- •Refusal to participate in the study
结局指标
主要结局
Atelectasis incidence
时间窗: 5 minutes
Assess incidence of SpO2 \< 97% 15 minutes after anesthesia induction during a 5 minutes long air test (FiO2 \< 0.25).
Accuracy of Pediatric Air test trial
时间窗: 5 minutes
Assess incidence of lung collapse (hence atelectasis incidence) 15 minutes after anesthesia induction using an air test (FiO2 \< 0.25). Collapse blind validation using lung US
次要结局
- Atelectasis severity(5 minutes)
- Atelectasis risk factors assessment(5 minutes)
研究者
Patricio Gonzalez Pizarro
MD, PhD
Hospital Universitario La Paz