Ultrasound Guidance Versus Anatomical Landmarks for Subclavian Vein Catheterization

NCT04690296 | Completed

• 1 other identifier: UTEM USG SCV
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

This was a prospective randomized study. After prior approval by the Ethics Committee, we included all patients aged over 18 years- old who were admitted to the intensive care unit (ICU) and who required a central venous catheterization (CVC) outside the emergency's context. Non-inclusion criteria were thrombosis of the vein or coagulopathy. All catheterizations were done by the same non-experimented practitioner. Patients were randomized into two groups according to the catheterization's technique of subclavain vein: real-time long axis ultrasound guidance (US group) and anatomical landmarks ( LM group). The main outcome was success. The secondary outcomes were: success' rate at first puncture, number of punctures, rate of redirections, number of redirections, access's time, preparation and spotting time and rate of complications (arterial puncture, hematoma, pneumothorax, wrong position of the catheter). Data analysis was performed using the SPSS® software version 20: The Student's "t" test was used to compare the normally distributed quantitative variables, the Mann-Whitney's test for non-normally distributed quantitative variables and the Chi-square and Fisher tests for qualitative data. A value of p \<0.05 was considered as statistically significant.

Conditions

Central Venous Catheterization

Keywords

ultrasound guidance; central venous catheterization; subclavain vein

Outcome Measures

Primary Outcomes (1)

• the successful insertion of the catheter.

  Failure was defined by a number of attempts greater than or equal to five

  During the venous cannulation procedure

Secondary Outcomes (2)

• the success's rate in the first attempt

  During the venous cannulation procedure

• The evolution of the blood reflux time (success) as a function of the rank of the patients in the 02 groups

  During the venous cannulation procedure

Study Arms (2)

US group

EXPERIMENTAL

a group underwent real time USG-SCV catheterization

Device: cathetherization approach

LM group

EXPERIMENTAL

a group in whom anatomical LM method was used

Device: cathetherization approach

Interventions

cathetherization approach DEVICE

real time ultrasound guidance versus anatomical landmarks subcalvain vein catheterization

LM group; US group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients admitted in intensive care unit requiring a central venous catheter (CVC)

You may not qualify if:

• Major blood coagulation disorders,
• Any thrombotic formations within the vein,
• Congenital or acquired deformity of neck or clavicle
• Cannulation site infection, hematoma and surgery

Sponsors & Collaborators

• University Tunis El Manar: lead

Study Officials

• mechaal benali, PROFESSOR

  university manar Tunis tunisia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 27, 2020
• First Posted: December 30, 2020
• Study Start: January 5, 2015
• Primary Completion: June 20, 2015
• Study Completion: June 20, 2015
• Last Updated: December 30, 2020

Record last verified: 2020-12