Influence of Point of Care Ultrasonography on Outcome of Inpatients Admitted To the Internal Ward
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Length of hospitalization
研究概览
简要总结
This is a Prospective, Double-center, randomized clinical trial. The purpose of the trial is to evaluate the benefit of adding POC US to the management of inpatients admitted to the internal ward with respiratory, cardiovascular or hemodynamic abnormalities.
详细描述
This is a Prospective, Double-center, randomized clinical trial. The purpose of the trial is to evaluate the benefit of adding POC US to the management of inpatients admitted to the internal ward with respiratory, cardiovascular or hemodynamic abnormalities.
This is a stage 1 pilot trial aimed to provide better understanding on the study population and study groups. This trial will comprise a total of 60 patients, 30 subjects on the intervention group and an equal number on the control group. The results of this pilot trial will be to design a larger trial and calculate a required sample size.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Patients admitted to internal ward
- •No previous internal ward admission within the last 6 months
- •At least one symptom or sign of the following on admission:
- •Respiratory abnormalities: Dyspnea, RR>20, O2 SAT<90% requirement of oxygen or non-invasive ventilation or mechanical ventilation
- •Cardiovascular abnormalities: Chest pain, HR>100, new/worsening peripheral edema, newly diagnosed ECG changes
- •Hemodynamic instability: SBP<90 mmHg or on vasopressor infusion or pre-renal azotemia
排除标准
- •Patients with cognitive impairment or cannot sign informed consent.
- •Subject enrolled in a different study
- •Patients with end stage disease receiving Palliative/end of life treatments.
- •Pregnant patients.
- •Patients that were given a consult by one of the research members pre enrollment
- •Patient under responsibility of one of the study team members
研究组 & 干预措施
Study group
All patients included in intervention group will be examined with an ultrasound machine with cardiac probe and vascular probe [Saote/ Mylab 5/ Italy] using both 2 dimensional and color Doppler imaging modalities according to our local point of care ultrasonography protocol.
Including demographic and medical data collection. Also, a wellbeing questionnaire will be filled by the investigator.
干预措施: Point Of Care Ultrasound (Device)
Control group
All patients included in the control group won't be examined with an ultrasound machine. Participation including demographic and medical data collection. Also, a wellbeing questionnaire will be filled by the investigator.
结局指标
主要结局
Length of hospitalization
时间窗: 1 month
次要结局
- Readmission rates(15 months)
研究者
Yael Ben Baruch Golan MD
Dr. Yael Golan
Soroka University Medical Center