The incidence of Pulmonary Alveolar Interstitial Syndrome (PAIS) by Lung Ultrasonography (LUS) during operative hysteroscopy - A Prospective Observational Pilot Study
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 identify the proportion of patients developing Pulmonary Alveolar Interstitial Syndrome (PAIS) by LUS in women undergoing Operative Hysteroscopy with Intrauterine Fluid Irrigation.
研究概览
简要总结
This is a prospective, observational, non-randamized, single-centre trial which aims to investigate the incidence of Pulmonary Alveolar Interstitial Syndrome (PAIS) using Lung Ultrasonography (LUS) during operative hysteroscopy. After obtaining necessary consent, eligible patients will be enrolled. Anesthesiologists will decide the type of anesthesia, and patients will be monitored continuously during surgery. LUS will be performed at regular intervals to detect PAIS, with images analyzed for B-lines indicating pulmonary fluid. The primary outcome is the detection of proportion of patients developing PAIS during the procedure by LUS. Secondary outcomes include detection of patients requiring oxygen therapy/diuretic therapy, compare signs between LUS and chest auscultation.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Female
入选标准
- •Adult female patients undergoing elective operative hysteroscopic procedures with intrauterine fluid irrigation under neuraxial or general anesthesia.
排除标准
- •Patients pre-diagnosed with lung disorders
- •Patients with chest deformities/with narrow rib spaces.
结局指标
主要结局
To identify the proportion of patients developing Pulmonary Alveolar Interstitial Syndrome (PAIS) by LUS in women undergoing Operative Hysteroscopy with Intrauterine Fluid Irrigation.
时间窗: Intraoperative period
次要结局
- To study the proportion of patients requiring intraoperative and postoperative oxygen therapy with or without positive pressure (non-invasive or invasive ventilation) with FiO2 more than 0.4 to maintain saturation more than 94 percent.(Intraoperative and postoperative period)
- To determine the proportion of patients requiring diuretic therapy.(Intraoperative and postoperative period)
- To compare signs of Pulmonary Alveolar Interstitial Syndrome by Lung ultrasonography with chest auscultation.(Intraoperative period)
- To determine the proportion of patients in whom Lung Ultrasonography is feasible till the end of the surgery.(Intraoperative period)
研究者
Dr Harish Balakrishnan
Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER)