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临床试验/CTRI/2024/09/074167
CTRI/2024/09/074167招募中4 期

Assessing the Effect of Intercostal Drain Clamping Prior to Removal versus No Clamping on Subsequent Ipsilateral Invasive Pleural Drainage in Pneumothorax Patients: A Randomized Controlled Trial

All India Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 138 人开始时间: 2024年10月2日最近更新:

试验速览

阶段
4 期
状态
招募中
入组人数
138
试验地点
1
主要终点
Comparison of proportion of patients undergoing Ipsilateral invasive pleural drainage procedure up to 24 hours of chest drain removal between groups A and B.

研究概览

简要总结

While intercostal chest drain insertion remains a cornerstone in pneumothorax management, the optimal approach for subsequent management post-drain removal remains a subject of debate. Specifically, the decision between clamping the chest drain before removal versus non-clamping lacks consensus and is often guided by individual clinician preference rather than empirical evidence.

This thesis addresses this gap by comparing ipsilateral invasive pleural drainage procedures following Intercostal Chest Drain (ICD) removal in pneumothorax patients. The study will adopt a randomized controlled trial (RCT) design to compare the efficacy, safety, and clinical outcomes of clamped and non-clamped approaches. By rigorously evaluating these two management strategies, this research seeks to provide valuable insights into the optimal post-drain removal management protocol for pneumothorax patients.

Research Hypothesis: Clamping the intercostal drain before removal is non-inferior to not clamping the drain in terms of the need for subsequent ipsilateral invasive pleural drainage in pneumothorax patients.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Diagnosis of “pneumothorax”, planned for ICD removal (There is full lung re-expansion and cessation of air leak).

排除标准

  • Patients with significant hydropneumothorax/pyopneumothorax/haemothorax Bilateral pneumothorax Trapped lung Patients who were on invasive mechanical ventilation at the time of tube removal.

结局指标

主要结局

Comparison of proportion of patients undergoing Ipsilateral invasive pleural drainage procedure up to 24 hours of chest drain removal between groups A and B.

时间窗: 24 hours

次要结局

  • To determine the proportion of patients detected with occult air leak by clamping prior to ICD removal.(6 hours)
  • Comparison of the proportion of patients developing pneumothorax up to 24 hours of ICD removal in groups A and B.(24 hours)
  • Comparison of the proportion of patients with complications in both groups(24 hours)
  • Comparison of the median duration of hospital stay amongst two groups.(Till discharge)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Ruchi Dua

All India Institute of Medical Sciences

研究点 (1)

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