Evaluation of Effect of Pv-aCO2-Gap on Clinical Outcomes With Standard Resuscitation End-points in Adult Poly-trauma Patients Admitted to the ICU --- Prospective Randomized Control Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Length of mechanical ventilation
研究概览
简要总结
dult patients with multiple traumatic injuries admitted to the ICU from the operating room, emergency department, or hospital wards who meet the study criteria will be included after obtaining informed consent from the patient or their legal guardian. Participants will be randomly divided into two groups: one group will receive treatment guided by the difference between carbon dioxide levels in venous and arterial blood, while the other group will receive treatment based on standard resuscitation parameters commonly used in critical care. As part of routine monitoring, all patients will have a central venous catheter and an arterial line inserted to measure blood parameters. Blood samples from both lines will be taken shortly after ICU admission and at regular intervals during the first three days. These samples will be analyzed using a bedside blood gas machine, and the results will be compared between the two groups to determine whether monitoring the difference in carbon dioxide levels between venous and arterial blood improves patient outcomes compared with standard care.
详细描述
All polytrauma patients admitted to the ICU from the operating theater, emergency department, or hospital wards who fulfill the inclusion criteria will be enrolled in the study after obtaining written informed consent from the patients or their legal representatives. Participants will be randomized in a 1:1 ratio using a computer-generated method into two groups: an intervention group managed with a Pv-aCO₂ gap-targeted approach and a control group managed according to standard resuscitation end-points. As part of routine hemodynamic monitoring in critical care, a central venous catheter (two- or three-lumen catheter-Arrow) and an arterial catheter (Arterial Leader Cath-Vygon or Teleflex) will be inserted in all participants before or immediately after ICU admission. After insertion, the position of the central venous catheter tip at the junction of the superior vena cava and right atrium will be confirmed by chest X-ray. Arterial and venous blood samples for blood gas analysis (ABGA and VBGA) will be obtained in the ICU using a point-of-care gas analyzer (ABL800 FLEX®, Radiometer) within 1 hour of ICU admission and subsequently at 6, 12, 24, 48, and 72 hours. The time interval between arterial and venous blood sampling will be kept under 5 minutes to minimize bias, and the measurements obtained at different time points will be compared with standard resuscitation end-points.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Either Gender
- •Poly-trauma patients
- •○ Both penetrating and blunt trauma
- •Both surgical and non-surgical
- •Shock States
排除标准
- •Any Chest trauma
- •Patients with Obstructive and restrictive lung disease
- •Obstructive sleep apnea
- •Septic shock
- •Pregnant patients
- •Patients who will require readmission within 48 h after step-down from the ICU.
- •Patients who will need extra-corporeal membrane oxygenation support
研究组 & 干预措施
Carbondioxide gap group
干预措施: Veno-arterial Carbondioxide gap (Diagnostic Test)
Conventional resuscitation group
干预措施: Conventional resuscitation end points (Diagnostic Test)
结局指标
主要结局
Length of mechanical ventilation
时间窗: This will be the number of days of ventilatory support once patient is admitted to ICU
次要结局
- ICU stay(This will the total length of ICU stay measured in number of days)
- qSOFA score(This will be measured at time of admission in ICU then at 48h and 72h following admission)
- ICU Mortality(This will be the death occurring during ICU stay)
研究者
Muhammad Haroon Anwar
Principal Investigator
Pakistan Institute of Medical Sciences