Agitated Saline Versus Chest X-ray for Determination of Correct Position of Central Venous Catheter: a Non-inferiority Study
试验速览
- 阶段
- 不适用
- 入组人数
- 260
- 主要终点
- Accuracy of central line placement
研究概览
简要总结
Central venous lines insertion are common procedures these days. CVL placed under USG guidance have high success rates and low complications even in developing country settings. However, the investigators still have to rely on chest x-ray (CXR) to confirm the correct placement of central venous lines as a gold standard method. This might be time consuming and may cause delay in initiation of treatment. In some cases, as in operating room, the treatment is started even before confirmation by CXR. Ultrasound has ability to localize the tip of the catheter at the superior venacava- right atrium junction using agitated saline and the appearance of contrast within 2 seconds in right atrium. However, this technique is rarely used. The investigators, therefore, designed the trial to study whether confirmation of tip of CVL by ultrasound is non-inferior to the CXR confirmation.
详细描述
Central venous lines (CVL) are placed in various in-hospital settings like operation theaters, emergency departments, oncology departments, and intensive care units for various purposes. Like any invasive procedures, placement of central lines is invariably associated with certain risks of inadvertent complications which are often life-threatening which occur because of the intricacy of the structures around the vascular access site like pleura, arteries, nerves, heart, etc. Measures such as landmark guidance, electrocardiographic guidance, fluoroscopy/C-arm-guided, and recently ultrasound image guidance have been in place to prevent and/or minimize the occurrence of such complications. Although the incidence of such complications have decreased considerably4, the rates have not reached the nadir.
Failure of confirmation of the correct placement of a CVL can have serious consequences. The consequences of an inadvertently misplaced catheter are grave for the patient be it the failure to elicit the vasopressor effect, unnecessary delay in starting of caustic substances like hypertonic fluids, parenteral nutrition, concentrated agents, etc., these will ultimately increase the morbidity and mortality. Thus, it becomes imperative that we confirm the accurate placement of CVL before infusing anything through these lines.
The confirmation of accurate placement of CVL is usually done by performing a post-procedure chest x-ray (CXR) which is done at the point of care if possible like in ICU or after shifting of patient to a post-operative ward in an operation theater setup. The most important constraint in obtaining CXR after CVL placement is the considerable amount of time it takes before a film is obtained even in center where there is a dedicated portable CXR for that purpose. For CVL placed in the operating theater, it is not always possible to do a portable CXR immediately after the procedure and at many times we have to immediately start infusion/medications through it even before confirmation of their proper placement. Secondly the very well-known problem of radiation hazard is a potential deterrent to the use of CXR each time a CVL is placed. When a large volume ICU is compared, the risk of radiation is inadvertently extended to all of the patients even though lines are placed in some. The hazard of the radiation to the ICU and ED staffs is always a concern considering the difficulty they face in escaping the hazard when they are taking care of sick patients. Thirdly, it is difficult to obtain an accurate CXR film in critical care unit setups where the patient are sometimes unable to hold breaths at inspiration (for the proper x-ray film) and the film so obtained may not be reliable enough to read. Fourthly, the overall costs in obtaining CXR for each and every single central lines placed will add to the overall healthcare costs at a time when the investigators are looking for reasons to cut down on health expenses.
Considering the fact that these lines are placed under ultrasound guidance, the rate of inadvertent complications are very few. But subjecting every single individual to an x-ray cannot always be justified. Nevertheless, this is not to say that central lines should not be confirmed for their proper placement, but certainly there is an imminent need of a simple, reliable, and more cost effective alternative to CXR. The very same ultrasound machine at point of care can be utilized for this purpose addressing most of the limitations of the CXR.
With simple, directed teaching it is possible for anyone with basic knowledge in ultrasound to do a focused point of care ultrasound to evaluate the accurate placement of CVL. This simple approach has several potential benefits. The first one being the saving of precious post-procedure time that is lost in obtaining a chest x-ray. The potential radiation hazard due to CXR is virtually eliminated. The same ultrasound can also be utilized for scanning the thorax to exclude pneumothorax and hemothorax and avoid potential delay in their management. If the sensitivity and specificity of ultrasound in accurately delineating the position of CVL is comparable to the chest x-ray, then obtaining of chest x-ray for confirmation can virtually be eliminated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Care Provider)
盲法说明
The participants will not have any knowledge of the intervention and the investigator who is doing the ultrasound confirmation will not have access to the results of the chest x-ray confirmation until the end of the study period when all the data is analyzed.
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 > 18 years admitted to ICU or presenting to operation theater for surgical procedures
- •Patients with indications for above the diaphragm CVL placement
- •All above the diaphragm central venous lines placed under ultrasound guidance.
排除标准
- •Age <18 years
- •Pregnant patients
- •Patients with moderate and severe RV dysfunction
- •Patient with moderate and severe tricuspid regurgitation
研究组 & 干预措施
Agitated Saline Method
The proper placement of the central venous line will be confirmed using agitated saline under ultrasound vision
干预措施: Agitated Saline Method (Procedure)
Agitated Saline Method
The proper placement of the central venous line will be confirmed using agitated saline under ultrasound vision
干预措施: chest x-ray (Procedure)
Chest X-Ray Confirmation
The proper placement of the central venous line will be compared with chest x-ray obtained in supine position after central line placement
干预措施: Agitated Saline Method (Procedure)
Chest X-Ray Confirmation
The proper placement of the central venous line will be compared with chest x-ray obtained in supine position after central line placement
干预措施: chest x-ray (Procedure)
结局指标
主要结局
Accuracy of central line placement
时间窗: 7 months
1. To compare the accuracy of ultrasound guided agitated saline confirmation and chest x-ray confirmation of central venous line position
次要结局
- Compare the time required for confirmation(7 months)
- Accuracy of malposition detection(7 months)
研究者
Dr. Achyut Sharma
MD Anesthesia and Intensive Care
Nepal Mediciti Hospital
