To evaluate the role of ultrasound guided umbilical venous catheter insertion vs Standard insertion i.e. without ultrasound in decreasing rate of misplacement of catheter tip in neonates.
- Conditions
- Preterm [premature] newborn [other],
- Registration Number
- CTRI/2021/03/031894
- Lead Sponsor
- Lokmanya Tilak Municipal College and General Hospital Sion Mumbai
- Brief Summary
This study is an open, randomised, parallel group, single centre trial with aim to compare whether umbilical venous catheter insertion under ultrasound guidance reduces rate of catheter tip malposition rates compared to standard insertion followed by radiograph in neonates admitted in NICU. Primary objective is reduction in catheter tip malposition rates when catheter insertion done by ultrasound guidance in neonates admitted in NICU. In the secondary objectives we will also see if it leads to reduction in number of catheter tip repositioning required, time taken to insert catheter in both groups, to compare accuracy of ultrasound compared to radiograph in determining catheter tip position. Catheter tip if malpositioned will be noted and any effect of weight on rate of malposition will also be noted.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 50
All neonates admitted in NICU requiring umbilical venous catheter insertion within 1st week of life will be included.
Major congenital anomalies of thorax and abdomen.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective is the reduction in the catheter tip malposition rates when catheter insertion done ultrasound guidance in neonates admitted in NICU. Optimal position on radiograph is defined when it is placed between T8 and T10 on radiograph and on USG where the catheter tip is in the IVC between the hepatic veins confluence and right atrium opening. A vertebral landmark of T8 to T10 corresponds to the vena cava right atrial junction in 90 percent of the neonates Immediate
- Secondary Outcome Measures
Name Time Method Reduction in number of catheter repositioning required Immediate To compare accuracy of ultrasound with radiograph (current gold standard) in determining catheter tip position. Immediate Time taken for the completion of procedure in both groups Immediate Role of catheter insertion by manoeuvre of aligning the umbilical vein and ductus venosus as described by Kishigami et al Immediate Position of catheter tip when malpositioned in both groups Immediate Rate of malposition in groups stratified according to weight Immediate
Trial Locations
- Locations (1)
Lokmanya Tilak Municipal College and General Hospital, Sion, Mumbai
🇮🇳Mumbai, MAHARASHTRA, India
Lokmanya Tilak Municipal College and General Hospital, Sion, Mumbai🇮🇳Mumbai, MAHARASHTRA, IndiaDr Amandeep KaurPrincipal investigator8727088015amans2488@gmail.com