Ultrasound Guided Recruitment Manauvere Versus Individualized Positive End Expiratory Pressure in Pediatric Patients Undergoing Laparoscopic Abdominal Surgery; A Prospective Randomized Controlled Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Intraoperative oxygenation
研究概览
简要总结
The aim of this prospective randomized controlled study is to compare the effect of US-guided Recruitment Manauvere (RM) versus individualized positive end-expiratory pressure (PEEP) on oxygenation and preventing respiratory complications in pediatric patients undergoing laparoscopic abdominal surgeries.
详细描述
Atelectasis is among the most frequent postoperative pulmonary complications (PPCs) of general anesthesia with an incidence of between 68% and 100% in children. Atelectasis impairs gas exchange, thus causing hypoxemia and other respiratory disorders such as acute lung injury and pneumonia.
Pneumoperitoneum is another risk factor for perioperative atelectasis. It elevates the diaphragm and intra-abdominal pressure. In order to prevent atelectasis, applying positive end-expiratory pressure (PEEP) or an alveolar recruitment Maneuvere (RM) have shown beneficial effects.
Lung ultrasound (US) is a noninvasive, radiation-free, convenient, and reproducible bedside imaging modality for anesthesia-induced atelectasis in children.
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
- None
入排标准
- 年龄范围
- 3 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 3 to 8 years.
- •Both sexes.
- •American Society of Anesthesiologists (ASA) physical status I-II.
- •Children scheduled for elective laparoscopic abdominal surgeries.
排除标准
- •Parental refusal.
- •Bronchial asthma or any preexisting chest disease.
- •Congenital deformity of the thoracic cage.
- •Patients with a history of thoracic surgery.
- •Cardiac, hepatic, or renal failure.
- •Obese children with BMI at or above 95th percentile of the same age and sex.
研究组 & 干预措施
Control group
Patients will receive a fixed positive end-expiratory pressure (PEEP) of 5 cmH2O.
干预措施: Fixed PEEP (Other)
PEEP IND group
Patients will receive individualized positive end-expiratory pressure (PEEP).
干预措施: Individualized PEEP (Other)
Ultrasound group
Patients will receive ultrasound -guided lung recruitment.
干预措施: Ultrasound-guided lung recruitment (Other)
结局指标
主要结局
Intraoperative oxygenation
时间窗: One hour after second recruitment Maneuvere
Intraoperative oxygenation which will be assessed by P/F ratio (the ratio of arterial oxygen partial pressure (PaO2 in mmHg) to fractional inspired oxygen P/F ratio will be assessed before induction of anesthesia, one hour after pneumoperitoneum, and after second recruitment Maneuvere (RM)
次要结局
- Mean arterial blood pressure (MAP)(One hour after extubation)
- Lung ultrasound scores(24 hours after extubation)
- Heart rate(One hour after extubation)
- Postoperative pulmonary complication(24 hours postoperative)
研究者
Reham Mostafa Mostafa Rezk
Principal Investigator of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.
Tanta University