Impact of Ultrasound Guided Central Venous Catheterization on Complications in Obese Patients in Intensive Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 264
- 试验地点
- 2
- 主要终点
- Rate of complications
研究概览
简要总结
Central venous catheterization (CVC) in ICU is very common. It is associated with many complications. These complications are now well identified in the literature. They are primarily mechanical, infectious and thrombotic events. Many measures are taken to reduce them as the choice of insertion site, strict aseptic technique during insertion and type of catheter used. However, despite these measures, it appears that the incidence of these complications is still high. The technique of ultra-sound guided (USG) catheter insertion has shown its effectiveness in reducing complications in the general ICU population. The increase in obesity in the general population is accompanied by an increase in the obese population in the ICU (BMI > 30 kg.m-2). Many studies have investigated the effect of obesity on morbidity and mortality in ICU. Some studies found a higher rate of catheter infections in obese patient. Moreover, insertion of central venous catheter is technically more difficult in obese patients.
To the investigators knowledge there are no studies on the impact of USG central venous catheterization in obese patients in ICU.
The objective of this prospective randomized controlled study is to demonstrate the superiority of USG central venous catheterization (jugular or femoral) on complications in a population of obese patients. 450 patients will be included and dispatched in two groups (jugular or femoral) according to the chosen site of catheter insertion. In both groups, patients will be randomized in the USG technique or the usual anatomical technique.
The rate of complications (mechanical, thrombotic or infectious) will be the primary endpoint. Secondary endpoints will be the following: rate of catheter colonization, rate of catheter-related bacteremia, rate of failure during insertion, number of punctures, procedure timing and mortality The investigators hope to establish a benefit in the use of USG central venous catheterization in obese ICU patients and thus contribute to improve the quality of care.
详细描述
Determination of the insertion technique
The insertion technique (with anatomical landmarks or ultrasound-guided) will be determined by randomization. To that aim, we will use a software available on an intranet server and available from all ICUs involved in the study.
All central venous catheters included in the study will be inserted by experienced physicians trained to the use of ultrasound for the placement of access (minimum 2 previous CVC installations with ultrasound).
The central catheters used in the study (Arrow International, Inc.) are single, double or triple lumen (16 and 20 cm in length). The choice will be made by the clinician in patient management. Catheters impregnated with antibiotics or antiseptics are excluded.
The ultrasound used will be a Site~Rite ® V (C.R. Bard Inc) type equipped with a multifrequency probe of 5-10 MHz.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Age over 18 years.
- •BMI ≥ 30 kg/m
- •Patient requiring the installation of a central venous catheter (femoral).
- •Informed consent signed.
排除标准
- •No particular exclusion criteria
研究组 & 干预措施
Anatomical guidance puncture
The patient is placed supine (with a slight neck extension for jugular punctures).
The preparation of the CVC installation will follow the procedures for disinfection, for skin preparation of the operator, for installation of sterile fields and for local anaesthesia.
The veins will be tracked by simple palpation of the carotid pulse.
The puncture will be made following:
- The anterior Boulanger's incision for the internal jugular vein;
- When venous aspiration is obtained, the catheter is assembled according to the Seldinger method.
干预措施: Central Venous Catheter Insertion (Procedure)
US-guided puncture
The patient is placed supine (with a slight neck extension for jugular punctures).
The ultrasound probe will be isolated by a sterile protective plastic and the operator will mount a ramp on which the puncture syringe needle is placed. A sterile gel will be used in order to visualize the vein and directly puncture under ultrasound guidance following:
- The anterior Boulanger's incision for the internal jugular vein pathway;
干预措施: Central Venous Catheter Insertion (Procedure)
US-guided puncture
The patient is placed supine (with a slight neck extension for jugular punctures).
The ultrasound probe will be isolated by a sterile protective plastic and the operator will mount a ramp on which the puncture syringe needle is placed. A sterile gel will be used in order to visualize the vein and directly puncture under ultrasound guidance following:
- The anterior Boulanger's incision for the internal jugular vein pathway;
干预措施: Ultrasound guidance (Device)
结局指标
主要结局
Rate of complications
时间窗: Within 4 days following installation of CVC
To compare the rate of complications (mechanical, thrombotic and infectious) of CVC posed by US-guided method vs. anatomical method on obese patients in ICU.
次要结局
- The rate of success/failure installation(Day 1)
- The time of installation(Day 1)
- Number of punctures(Day 1)
- Type of complications(Within 4 days following installation of CVC)
- Mortality(Within 4 days following installation of CVC)
- The duration of stay(Within 4 days following installation of CVC)