A study to compare success and complication rate of inserting catheter in the large central vein (Subclavian) using either ultrasound or landmark guided approach in patient receiving mechanical ventilation.

Completed

Conditions: Medical and Surgical,

Registration Number: CTRI/2022/04/042244

Lead Sponsor: All India Institute of Medical sciences

Brief Summary: A central venous catheter (CVC) is an indwelling vascular catheter with a tip that lies within the proximal third of the superior vena cava, the right atrium, or the inferior vena cava. Central venous catheterisation was first performed in 1929 by Werner Frossman using a ureteric catheter inserted through the antecubital vein and advanced into the right ventricle under fluoroscopy. Later on Sven-Ivar Seldinger in 1953, introduced a technique that facilitates catheter placement into lumens and body cavities. Since then, placement of a CVC using the Seldinger technique revolutionized medicine by allowing safe and reliable venous access.

Recently, the use of ultrasound (US) guidance and improvements in catheter care have further reduced complication rates.

The CVC can be inserted through a peripheral vein or a proximal central vein, most commonly the internal jugular vein (IJV), subclavian vein (SCV), or femoral vein. Among the patients admitted in intensive care unit (ICU), the SCV is a common site of CVC placement because of several associated advantages, including a lower incidence of thrombosis and catheter related blood stream infection (CRBSI), with better patient comfort and easier nursing care. It is analternative to IJV in hypovolemic or obese patients. SCV cannulation has the advantage of fixed landmarks but may be associated with potentially severe complications, e.g.,pneumothorax or hemothorax, likely related to limited operator experience.

The â€œglobal use of ultrasoundâ€ is a newer concept that highlights the role of US for central

venous access not only for planning but also for identifying early and late complications.

Based upon the available literature, the multidisciplinary consensus guidelines from various

societies recommended the use of real-time US guidance for IJV cannulation however, the literature is insufficient to recommend the use of US during SCV cannulation. A few

randomized controlled and observational studies are conducted to assess the role of real time

US guidance during SCV cannulation.

Hence, we are planning a randomized controlled open label study to evaluate the role of real

time US guidance for SCV cannulation. We hypothesize that the use of real time US guidance

during SCV cannulation would provide higher success rate and lower complication rate as

compared to anatomical landmark guided technique in mechanically ventilated critically ill patients

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 214

Inclusion Criteria

1. Patient aged 18years old or older.
1. Belonging to American Society of Anesthesiologist Physical Status 1-3.
1. Belonging to either sex.
1. Either scheduled for elective surgery requiring CVC or admitted in the ICU and receiving mechanical ventilation.

Exclusion Criteria

1. Patient having infection at the access site.
1. Patients with coagulopathy or on anticoagulation therapy.
1. Subclavian vein could not be visualised or appear thrombosed during initial screening.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the first attempt success rate of SCV cannulation using the two techniques	During Procedure

Secondary Outcome Measures

Name	Time	Method
To compare the overall success rate of SCV cannulation using the two technique	To compare the time required for successful SCV cannulation using the two technique

Trial Locations

Locations (1): All India Institute of Medical sciences
🇮🇳
Jodhpur, RAJASTHAN, India
All India Institute of Medical sciences
🇮🇳Jodhpur, RAJASTHAN, India
Praveen BK
Principal investigator
7022642652
praveenbk93@gmail.com