Hemodynamic Assessment With Trans-esophageal Doppler (TED) During Prone Ventilation in Patients With Acute Respiratory Distress Syndrome (ARDS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- To measure pattern of changes in cardiac index (L/min/m2) from baseline (pre-prone position) to during prone position.
研究概览
简要总结
Acute respiratory distress syndrome (ARDS) commonly complicates acute illness in ICU. This syndrome is associated with high morbidity and mortality. In management of ARDS patients, lung protective ventilation and prone ventilation are key strategies which have shown survival benefits in recent years. Prone positioning has been reported to have hemodynamic disturbances like hypotension and arrhythmias. The literature till date is unclear with regards to acute hemodynamic changes which can happen during initiation of prone ventilation ,with a few studies suggesting decreasing cardiac output and a few increasing cardiac output. In recent years, trans-esophageal Doppler (TED) has become one of important hemodynamic assessment tool due to its minimal invasiveness, ease of use with its clinical utility established by various studies both in operation theatres and intensive care units. In current study, the investigators would like to evaluate acute hemodynamic effects of prone ventilation with TED in patients of acute respiratory distress syndrome (ARDS).
详细描述
Introduction and rationale of the study:
Acute respiratory distress syndrome (ARDS) commonly complicates acute illness in intensive care units (ICU). This syndrome is associated with high morbidity and mortality. In management of ARDS patients, lung protective ventilation and prone ventilation are key strategies which have shown survival benefits in recent years and now becomes standard part of care in these patients. Prone positioning has been reported to have hemodynamic disturbances like hypotension and arrhythmias. Prone ventilation can have different cardiovascular effects with a few suggesting increased cardiac output and few decreased cardiac output with unclear literature till date with one recent study suggesting that patients who have preload reserve had increased cardiac output when compared to patients with no preload reserve.
In ICU, hemodynamic monitoring is being done as a part of standard care of management in critically ill patients. There are different modalities of continuous hemodynamic monitoring, which help in timely assessment and appropriate interventions to optimize cardiac output to maintain adequate organ perfusion in these critically ill patients. Cardiac output could be assessed by thermo-dilution technique with pulmonary artery catheter, pulse contour analysis of arterial waveform or echocardiography. In recent years, trans-esophageal Doppler (TED) has become one of the standard hemodynamic assessment tool in ICU due to its minimal invasiveness and easy to use. TED uses Doppler shift principle which is routinely used to measure cardiac output in both trans-thoracic and trans-oesophageal echocardiography. The clinical utility of TED, with the benefit of minimal invasiveness, in assessing hemodynamic perturbations in both operation theatre and ICU has been established by various studies. Doppler measured cardiac output showed high validity and clinical agreement with gold standard pulmonary artery thermo-dilution technique, which is more invasive. Hemodynamic assessment in prone position with TED has been studied intra-operatively with good correlation. In current study, the investigators will evaluate acute hemodynamic effects of prone ventilation with TED in patients of acute respiratory distress syndrome (ARDS).
Work plan methodology:
This will be a prospective, observational study, to be conducted in 12 bedded ICU of department of Critical Care Medicine, Sanjay Gandhi Institute of Postgraduate and Medical Sciences, Lucknow. Patients with ARDS whose hemodynamic monitoring is being done by TED, and planned for prone ventilation by treating physician's decision, will be screened for inclusion in this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (age > 18 years) with ARDS undergoing prone ventilation
排除标准
- •Patients with age <18 years.
- •Conditions which can interfere with interpretation of hemodynamic parameters through TED (aortic coarctation, severe aortic stenosis, severe aortic regurgitation, severe scoliosis)
- •Pregnant patients
结局指标
主要结局
To measure pattern of changes in cardiac index (L/min/m2) from baseline (pre-prone position) to during prone position.
时间窗: Baseline (pre-prone) and after initiation of prone-ventilation at 5, 10, 20 and 30 minutes.
次要结局
未报告次要终点
研究者
Mohan Gurjar
Associate Professor
Sanjay Gandhi Postgraduate Institute of Medical Sciences
