Inverse Ratio Ventilation Versus Conventional Ratio Ventilation During One Lung Ventilation in Neonatal Open Repair of Esophageal Atresia/Tracheoesophageal Fistula: A Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Incidence of severe desaturation episodes
研究概览
简要总结
Background and Objectives: Maintaining oxygenation during neonatal open repair of esophageal atresia is difficult. Inverse ratio ventilation can be used during one lung ventilation (OLV) to improve the oxygenation and lung mechanics. The investigators will compare inverse ratio to conventional ratio ventilation during OLV in neonatal open repair of esophageal atresia regarding effect in oxygenation, hemodynamic variables, incidence of complications, and easiness of procedure.
Methods: The investigators will enroll 40 term neonates undergoing open right thoracotomy for esophageal atresia repair in this prospective randomized study. The patients will be randomly assigned into 2 groups based on inspiratory to expiratory (I:E) ratio of mechanical ventilation parameters (I:E ratio will be 2:1 in IRV and 1:2 in CRV). The incidence of desaturation episodes that needs to stop the procedure and reinflation of the lung will recorded as the primary outcome while hemodynamic parameters, incidence of complications, and length of surgical procedure will be recorded as the secondary outcomes.
详细描述
INTRODUCTION:
Maintaining adequate oxygenation after lung retraction and one lung ventilation (OLV) in open thoracotomy during neonatal repair of esophageal atresia/ tracheoesophageal fistula is extremely difficult and usually required stopping the procedure and reinflation of the retracted lung which prolong the surgery time, stopping the procedure during critical situations and endanger the fragile neonate from hypoxemia.
Inverse ratio ventilation has been used originally for long time in patients with acute respiratory distress syndrome (ARDS) to improve the oxygenation and lung function. The mechanism with inverse ratio ventilation is to prolong the inspiratory time with reducing the airway pressure and elevate the mean airway pressure preventing the alveoli from collapse. Also inverse ratio ventilation (IRV) used in many studies in adults during OLV with better oxygenation and lung mechanics.
Despite the standard ventilatory sitting in neonatal anesthesia is to adjust the inspiratory time to achieve inspiratory to expiratory (I:E) ratio of 1:2 to 1:3, but inverse I:E ratio (with inspiratory time longer than expiratory time) up to 4:1 in neonatal mechanical ventilation has been shown to be effective in improving oxygenation, PaO2, and gas distribution in atelectatic lungs. Inverse I:E ratio in neonatal mechanical ventilation should be used in caution and for a short period of time to avoid possible complications as air trapping/auto PEEP, volutrauma, air leaks, decrease venous return, and increase pulmonary vascular resistance.
AIM/ OBJECTIVES:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients will be of ASA physical status II-III, neonates aged less than 28 days and undergoing open repair of esophageal atresia/tracheoesophageal fistula with right thoracotomy. All patients' will be full term with gestational age ≥ 36 weeks and weigh ≥ 2.5 kilograms.
排除标准
- •Significant congenital heart disease including cyanotic heart disease, single ventricle pathology, large intracardiac defect with significant left to right shunt, and severe pulmonary hypertension more than 50 mmHg. Other exclusion criteria included prematurity, pneumonia or severe chest infection prior to the surgery, and parent or guardian refusal.
结局指标
主要结局
Incidence of severe desaturation episodes
时间窗: 6 months
Incidence of desaturation episodes that needs to stop the procedure and reinflation of the retracted lung.
次要结局
- Heart rate(6 months)
- Length of surgical procedure(6 months)
- Oxygen saturation(6 months)
- Mean blood pressure(6 months)
- Incidence of complications(6 months)
研究者
Akram Mohamed Mohamed Amer
Lecturer in the department of Anesthesia
Ain Shams University