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临床试验/CTRI/2021/04/033104
CTRI/2021/04/033104招募中不适用

Effect of optimum positive end expritaory presssure(PEEP) on post-operative lung atelectasis in children- A randomised controlled trial

Deaprtment of anaesthesiology pain medicine and critical care1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年1月5日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
80
试验地点
1
主要终点
To find the incidence of significant atelectasis defined as consolidation score 2 in any region in post operative lung ultrasound assessment.

研究概览

简要总结

General anaesthesia used during surgery predisposes patients to postoperative pulmonary compliacations which includes pneumonia, atelectasis, respiratory failure etc which increases the morbidity and mortality of patients postoperatively. Children are more susceptible because of their anatomical and physiological differences such as the decreased FRC due to the increased compliance of their chest wall which provided reduced counterbalance to the inward elastic recoil of the lugs. Application of lung recruitment manoeuver, appropriate PEEP thus becomes necessary to keep the alveoli open and maintain adequate oxygenation during the course of surgery. We hypothesize that an optimum PEEP based on best lung compliance  can improve intraoperative oxygenation and thus reduce postoperative lung atelectasis as assessed by lung ultrasound score

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
4.00 Year(s) 至 15.00 Year(s)(—)
性别
All

入选标准

  • Elective major orthopaedic surgery in supine position.

排除标准

  • 1.Parental refusal to participate in the study.
  • 2.Children with known severe lung disease.
  • 3.Children with a history of severe lung infection having post infection sequelae in preoperative chest x-ray.
  • 4.Children with known deformity of chest wall or thoracic spine.
  • 5.Children undergoing spine surgery in prone or lateral position.
  • 6.Children with pre-existing significant cardiac, renal or hepatic diseases.
  • Children with history of previous thoracic surgery.
  • 8.Children with BMI > 30 kg/m2.

结局指标

主要结局

To find the incidence of significant atelectasis defined as consolidation score 2 in any region in post operative lung ultrasound assessment.

时间窗: lung ultrasound images will be obtained at 4 predefined time points: | T-1 Before induction of general anaesthesia | T-2 Five minutes after intubation before lung recruitment | T-3 Before extubation | T-4 One hour after extubation in PACU (Post Anaesthesia Care Unit)

次要结局

  • Correlation of lung ultrasound score with(PaO2 / FiO2 ratio)

研究者

发起方
Deaprtment of anaesthesiology pain medicine and critical care
申办方类型
Government medical college

研究点 (1)

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