Comparison of Ultrasound-Guided Internal Jugular Vein Cannulation in Supine and Lateral Position:A Prospective Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 104
- 试验地点
- 1
研究概览
简要总结
Patients are typically positioned supine when central venous catheters are inserted.However, when a patient is in the lateral position for various surgeries (like VATs, thoracotomies,nephrectomies, orthopedic surgeries) and urgent central venous access is required, catheter placementwith the patient in the lateral position may be necessary. It may be necessary in the operating room when the patient is in the lateral position, has significant blood loss, and requires urgent CVC insertion for the initiation of vasopressor drugs. Changing patients in the supine position for CVC insertion could waste time, cause hemodynamic instability, hinder the sterility of surgical drapes or positioning, and put airways at risk, particularly if they are under general anesthesia. To our knowledge, CVC insertion in lateral
position has not been studied thoroughly. There is limited evidence comparing the safety, efficacy, and success rates of IJV cannulation in the lateral position versus the standard supine position. Consequently,we intend to compare USG-guided IJV cannulation in the supine and lateral positions.
This study addresses a gap in clinical knowledge regarding central venous access in alternative patient positions. Results may influence
guidelines and improve patient safety and procedural success in critical care and surgical settings where supine positioning is contraindicated or impractical.
Population- Patients aged more or equal t o 18 years, ASA status 1-3,scheduled for surgery in lateral position and requiring CVC
Intervention- Ultrasound guided IJV cannulation in lateral position
Comparator-Ultrasound guided IJV cannulation in supine position
Outcome- First attempt success rate
Timeline- 12 months
Research Question
"Is the first-attempt success rate of ultrasound-guided internal jugular vein cannulation in the lateral position non-inferior to the supine position among adult patients requiring central venous access?"
Aims and Objectives
Comparison of ultrasound-guided internal jugular vein cannulation in supine and lateral
position
• Primary Objective-
To compare the first attempt success rate of IJV cannulation in supine and
lateral position
Secondary Objectives-
- To compare the access time of IJV cannulation in the two positions.
2 . To compare the guide wire insertion time of IJV cannulation i n the two
positions.
3 . To compare the catheterization time of IJV cannulation in the two positions.
- To compare the number of attempts taken for IJV cannulation in the two
positions.
-
To compare the total success rate of IJV cannulation in the two positions.
-
To compare the complications of IJV cannulation i n the two positions.
-
Operator satisfaction using likert scale 1to 5
8.Operator experience in US guided IJV cannulation will be noted
Study Participants:
Inclusion criteria:
Age equal to or more than 18 years
Patients scheduled for surgery in lateral position, requiring Central venous cathetrisation
Exclusion criteria:
Patients with previous surgery at the site of insertion
Infection at the site of insertion
Patients with coagulopathy or on anticoagulation therapy.
Internal jugular vein could not be visualized or appear thrombosed during initial screenin
Sample Size Calculation:
Julie Leung et al have reported that IJV cannulation success rate was 82 percent in supine position. Assuming an alpha = 0.05 (one-sided for non-inferiority), power 80 percent and non-inferiority margin 20 percent (procedural outcomes) and 10 percent contingency for dropouts, the sample size is calculated as 52 patients per group
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients Aged more than 18 years Patients scheduled for surgery in lateral position requiring central vein catheterisation.
排除标准
- •Patients with previous surgery at the site of insertion Infection at the site of insertion Patients with coagulopathy or on anticoagulation therapy Internal Jugular Vein could not be visualized or appear thrombosed during initial screening.
研究者
Dr Aswin P
AIIMS JODHPUR
