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临床试验/CTRI/2025/03/083178
CTRI/2025/03/083178尚未招募2 期

A randomised controlled study for effectiveness of ultrasound guided regular alveolar recruitment upon pre-extubation lung atelectasis in pediatric population below 2 years ofage, undergoing posterior sagittal anorectoplasty surgery.

SMS medical college jaipur1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年4月15日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
1. Mean consolidation score of various lung regions.

研究概览

简要总结

Atelectasis is a common complication in paediatric patients undergoing general anaesthesia, particularly in those under three years old, due to their reduced functional residual capacity and increased airway collapsibility. This randomised controlled interventional study aims to evaluate the effectiveness of regular alveolar recruitment using ultrasound in preventing intraoperative lung atelectasis in paediatric patients undergoing PSARP surgery in the prone position.

The study will compare two groups, one receiving a single alveolar recruitment manoeuvre at the start of the surgery and the other undergoing hourly alveolar recruitment. Lung ultrasound will be used to assess lung consolidation and B- line scores before extubation, The primary objective is to determine whether alveolar recruitment significantly reduces the incidence of pre- extubation atelectasis.

The null hypothesis states that there is no significant difference in occurrence of atelectasis between the two groups, and the alternative hypothesis proposes that regular recruitment reduces atelectasis. The study’s findings could provide valuable insights into optimizing intraoperative ventilation strategies to improve respiratory outcomes in paediatric anaesthesia.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant Blinded

入排标准

年龄范围
1.00 Day(s) 至 24.00 Month(s)(—)
性别
All

入选标准

  • Consenting parents or guardians.
  • patient posted for elective Posterior Sagittal Anorectoplasty.
  • surgery duration more than 1 hour.
  • ASA grade 1 and 2.

排除标准

  • Patient who is a part of any other study.
  • Non-consenting parent/guardian.
  • Patients with previous thoracic surgery.
  • History of lung disease, airway anomalies, or airway infection.

结局指标

主要结局

1. Mean consolidation score of various lung regions.

时间窗: 1. baseline supine scan- after induction of general anaesthesia. (0 min) | 2. baseline prone scan - after prone positioning of the patient. (5min) | 3. At 1hr, 2hr till surgery is complete.

2. Mean B-line score of various lung regions.

时间窗: 1. baseline supine scan- after induction of general anaesthesia. (0 min) | 2. baseline prone scan - after prone positioning of the patient. (5min) | 3. At 1hr, 2hr till surgery is complete.

次要结局

  • 1. Mean number of episodes of Desaturation (SpO2 less than 95%) during mechanical ventilation, emergence from general anaesthesia, and the postoperative period (upto 12 hours).(2. Mean episodes of hypotension during alveolar recruitment.)

研究者

发起方
SMS medical college jaipur
申办方类型
Government medical college

研究点 (1)

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