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临床试验/CTRI/2025/09/095058
CTRI/2025/09/095058尚未招募Unknown

Comparison of driving pressure guided optimum versus fixed positive end expiratory pressure to prevent atelectasis of lungs in paediatric laparoscopic abdominal surgery cases a prospective randomised double blind study

AIIMS, RAIPUR1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2025年9月28日最近更新:

试验速览

阶段
Unknown
状态
尚未招募
发起方
入组人数
44
试验地点
1
主要终点
To identify whether driving pressure guided optimum PEEP can reduce the magnitude of post-operative (30 minutes after extubation) lung atelectasis as compared to a fixed PEEP assessed by change in modified lung score.

研究概览

简要总结

Atelectasis, defined as the incomplete expansion of the lungs, is a significant concern during anesthesia and surgery, particularly in pediatric laparoscopic procedures. It results from the collapse of small airways, leading to impaired gas exchange and increased postoperative complications. Factors contributing to atelectasis include positive pressure ventilation, which can exacerbate lung collapse, and mechanical challenges posed by pneumoperitoneum and patient positioning.

This research aims to evaluate the effectiveness of two ventilation strategies—driving pressure-guided optimum PEEP versus fixed PEEP—in preventing atelectasis in pediatric laparoscopic surgeries. Driving pressure-guided ventilation optimizes lung recruitment and minimizes overdistention by adjusting ventilator settings based on driving pressure, which has been linked to improved lung compliance and reduced risk of atelectasis.

The study acknowledges existing literature indicating that lung-protective ventilation strategies, such as low tidal volume and PEEP application, are crucial in mitigating ventilator-induced lung injury (VILI). However, driving pressure has emerged as a critical factor in patient outcomes, with high driving pressures correlating with increased mortality.

A review of literature highlights the physiological challenges in pediatric patients, including higher oxygen consumption and lower functional residual capacity, which increase the risk of hypoxemia. Several studies have shown that appropriate PEEP levels improve oxygenation and reduce atelectasis during laparoscopic surgery.

This prospective randomized double-blind study seeks to provide insights into the optimal ventilation strategy for minimizing atelectasis and improving respiratory outcomes in pediatric patients. By comparing driving pressure-guided PEEP and fixed PEEP, the research aims to enhance clinical practices in pediatric anesthesia and surgery, ultimately improving patient outcomes and reducing hospital stays.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
1.00 Year(s) 至 7.00 Year(s)(—)
性别
All

入选标准

  • Patients of ASA GRADE 1 and 2 undergoing elective laparoscopic abdominal surgeries with informed consent.

排除标准

  • Patient parents refusal Pre-existing lung disease Chest wall or thoracic spine deformity Pre-existing significant cardiac, renal and hepatic diseases Previous history of thoracic surgery.

结局指标

主要结局

To identify whether driving pressure guided optimum PEEP can reduce the magnitude of post-operative (30 minutes after extubation) lung atelectasis as compared to a fixed PEEP assessed by change in modified lung score.

时间窗: Lung ultrasound at baseline, before pneumoperitoneum, after deflation of pneumoperitoneum and before extubation, 30 minutes after shifting to PACU

次要结局

  • To compare post-operative pulmonary complication within three days of surgery(Post-operative)
  • To compare requirement of supplemental oxygen to maintain oxygen saturation more than 94% in postoperative period and on first postoperative day(Post-operative)

研究者

发起方
AIIMS, RAIPUR
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Tripti Gautam

AIIMS Raipur

研究点 (1)

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