A randomized comparative study to evaluate the efficacy of ultrasound guided internal jugular vein cannulation in short axis approach using needle with a guard versus without a guard in SMS Medical College Jaipur.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Number of attempts for successful internal jugular vein (IJV) cannulation between both groups.
研究概览
简要总结
This is a prospective, randomized controlled trial conducted at the Department of Anaesthesia, SMS Medical College, Jaipur, aiming to evaluate the effectiveness and safety of using a needle with a guard versus a needle without a guard during ultrasound-guided internal jugular vein (IJV) cannulation using a short axis approach.
The primary focus is to compare the success rate, particularly the number of attempts for successful cannulation and the incidence of posterior venous wall puncture between the two groups.
Secondary outcomes include assessing the ease of cannulation, incidence of accidental common carotid artery puncture, anatomical variations of the IJV in relation to the carotid artery, and other complications like pneumothorax or hematoma.
The study uses computer generated randomization to allocate 150 patients equally into two groups (with and without needle guard) and it is single blinded, with patients blinded to the needle type.
The intervention involves utilising a specially designed non-PVC disc guard on the needle to limit its depth, potentially reducing complications associated with deep needle penetration.
The study sample size is based on achieving 80% power and 5% significance, accounting for a 10% dropout rate.
This trial seeks to provide evidence on whether using a guard improves the safety and efficiency of ultrasound-guided IJV cannulation compared with the conventional needle technique without a guard.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 19.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult patients of either sex scheduled for any elective surgery requiring internal jugular vein (IJV) cannulation.
- •Patients willing to provide informed consent.
- •Patients classified as American Society of Anesthesiologists (ASA) grade 1, 2, or
- •Patient age between 19 and 65 years.
排除标准
- •Any surgical intervention at the cannulation site.
- •Present or past history of neck mass.
- •Limited neck mobility.
- •Patients with infection, burn, trauma, or subcutaneous hematoma close to the puncture site.
- •Infection or phlebitis at the site of insertion.
- •Patients with body mass index (BMI) greater than 35 kg/m².
结局指标
主要结局
Number of attempts for successful internal jugular vein (IJV) cannulation between both groups.
时间窗: All outcomes were measured intra procedurally or immediately postprocedure. | No long term or follow up assessment time points were specified.
Incidence of posterior venous wall puncture between both groups.
时间窗: All outcomes were measured intra procedurally or immediately postprocedure. | No long term or follow up assessment time points were specified.
次要结局
- Ease of cannulation between both groups which was based on operator satisfaction rating(All secondary outcomes were evaluated intra procedurally during the cannulation procedure & & immediately post procedure before the patient left the operating or procedure area.)
- Incidence of accidental common carotid artery puncture between both groups.
- Incidence of various anatomical relationships of the internal jugular vein with respect to common carotid artery between the two groups.
- Correlation of anatomical variation in relationship of IJV with respect to CCA in cases of accidental common carotid puncture between the two groups.
- Other complications such as pneumothorax, vertebral artery puncture, and damage to other important structures of the neck between both groups.
研究者
Poonam Kalra
SMS MEDICAL COLLEGE Jaipur