Comparative Analysis of Initial Negative Pressure Pleural Suction Followed by Underwater Seal Drainage Versus Continuous Underwater Seal Drainage in Thoracic Trauma Patients: Impacts on ICD Duration, Hospital Stay, and Complication Rates
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- The study anticipates that initial negative pressure pleural suction followed by underwater seal drainage will reduce ICD duration, hospital stay, and complication rates compared to continuous underwater seal drainage in thoracic trauma patients.
研究概览
简要总结
This study aims to compare the effectiveness of Initial Negative Pressure Pleural Suction Followed by Underwater Seal Drainage with Continuous Underwater Seal Drainage in patients requiring pleural drainage for pleural effusions or pneumothorax. The research will be conducted as a randomized controlled trial, enrolling adult patients who meet the inclusion criteria. After obtaining informed consent, participants will be randomly assigned to one of two groups: the Initial Negative Pressure Pleural Suction group or the Continuous Underwater Seal Drainage group. In the Initial Negative Pressure group, patients will first receive pleural suction using negative pressure to swiftly evacuate air or fluid from the pleural cavity. Following this initial suction phase, an underwater seal drainage system will be employed to continuously manage and monitor pleural drainage. Conversely, participants in the Continuous Underwater Seal Drainage group will have a chest drain inserted and connected directly to an underwater seal drainage system from the beginning, avoiding the initial negative pressure phase. Both groups will be closely monitored for clinical outcomes with Regular chest X-rays which will be conducted to assess the resolution of the pleural condition and to ensure appropriate tube placement. Data collection will include metrics on drainage duration, length of hospital stay, and patient-reported comfort and satisfaction. Statistical analysis will compare the primary outcomes—time to resolution of the pleural issue and rates of complications—between the two drainage methods. The study will adhere to ethical standards, receiving approval from the relevant institutional review board, and ensuring informed consent from all participants. Follow-up will extend for at least 7 days or until clinical resolution, providing a thorough evaluation of both drainage strategies.
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
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients with blunt trauma chest requiring ICD insertion ICD inserted and negative pressure applied to test group and not applied in 2nd group.
排除标准
- •Pre-existing Conditions: Chronic pulmonary diseases (COPD ,Lung fibrosis, Emphysema) Mechanical Support: Need for mechanical ventilator support.
- •Prior Treatment: Referred patients with ICDs already placed in previous hospitals.
- •Those who does not give consent for ICD.
结局指标
主要结局
The study anticipates that initial negative pressure pleural suction followed by underwater seal drainage will reduce ICD duration, hospital stay, and complication rates compared to continuous underwater seal drainage in thoracic trauma patients.
时间窗: 1 week
次要结局
- Initial negative pressure reduces the duration & complications of ICD(1 week)
研究者
Karthik Kotari
AIIMS patna
