The Assessment of Efficacy and Safety of Step-wise up and Down PEEP Titration in Healthy Pediatric Patients Under General Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Partial pressure of oxygen
研究概览
简要总结
During general anesthesia lung collapses and atelectasis occurs. Preservation of atelectasis can cause pulmonary disfunction. The goal of safe anesthesia is to protect the lungs intraoperatively. Positive end-expiratory pressure (PEEP) is distending pressure that prevents alveolar collapse during mechanical ventilation and is a part of recruitment maneuver that is often used in patients on mechanical ventilation. Overall effect of PEEP is improvement in lung function. PEEP can have adverse effects on hemodynamics. The objective of this study was to assess the effect of step up and down PEEP titration on lung function and hemodynamics in healthy preschool children during general anesthesia. One group of children was ventilated with constant PEEP. the other was submitted to PEEP titration. Changes in lung compliance, gas exchange and hemodynamic status were documented as well as any unwanted effects.
详细描述
Seventy preschool children American Society of Anesthesiologists classification system (ASA) I and II scheduled for non-cardiothoracic surgery were allocated in two groups. Interventional group (n=35) received PEEP titration and Control group (n=35) didn't. They were ventilated only with PEEP 3. PEEP titration: In Intervention group, 20 minutes before the end of anesthesia PEEP was increased by 2 on every 5 breaths to 11. Ventilation with PEEP 11 was maintained for 2 minutes. Then PEEP was reduced by 2 on every 5 breaths to 5 and remain as until awakening. Total time to perform titration was 5 minutes. Blood was collected in both groups, in equal points of time that is: after induction, 20 minutes before the end of surgery and after the end of surgery (20th minute). Investigators tested differences of outcome variables between groups and within the Interventional group before and after PEEP titration. Hemodynamic monitoring and monitoring of lung function were conducted in Interventional group to observe changes during PEEP titration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 3-7; ASA I and II
- •absence of cardiovascular and respiratory comorbidity
排除标准
- •current or recent (up to 4 weeks) upper airway infection
- •present of gastroesophageal reflux
- •allergic reactions to anesthetics
- •contraindication to chosen anesthetics
研究组 & 干预措施
Intervention group
Intervention: increase and decrease positive end-expiratory pressure. PEEP titration: 20 minutes before the end of anesthesia and surgery PEEP was increased by 2 on every 5 breaths to 11 ventilation was maintained on PEEP 11 for 2 minutes.Then, PEEP was reduced by 2 for every 5 breaths to 5.Total time to titrate was 5 minutes.
干预措施: increase and decrease positive end-expiratory pressure (Procedure)
Control
Ventilation with PEEP 3 during anesthesia and surgery
结局指标
主要结局
Partial pressure of oxygen
时间窗: 10 minutes after PEEP titration
measured partial pressure of oxygen in arterial blood at the end of surgery in Interventional and Control group.
Partial pressure of carbon dioxide
时间窗: 10 minutes after PEEP titration
measured partial pressure carbon dioxide in arterial blood at the end of surgery in Interventional and in Control group
Lung compliance
时间窗: 5 minutes
spirometric measurement of dynamic lung compliance on different PEEP levels in Interventional group
次要结局
- intraoperative hemodynamic status(5 minutes)
- postoperative hemoglobin oxygen saturation(4 hours after extubation)
- intraoperative respiratory adverse effect(5 minutes)
研究者
Ana Mandras
Principal Investigator Anesthesiologist
Institute for Mother and Child Health Care of Serbia "Dr Vukan Cupic"