Point of Care Ultrasonography Versus Standard Blind Technique for Central Venous Catheter Insertion in Emergency Hospital

NCT05338138 | Completed DMC FDA Device

• 1 other identifier: ZU-IRB#:6827/30-3-2021
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

A lot of complications occur during central venous catheter insertion in intensive care units all over the world most commonly pneumothorax, misplacement and infection. So in this study we will assess the effect of using ultrasonography guidance for CVC insertion to reduce incidence of complications and to confirm placement compared to standard blind technique.

Conditions

Central Venous Catheter Placement

Outcome Measures

Primary Outcomes (1)

• the incidence of complications in ultrasound guided central venous catheter insertion

  the incidence of complications in ultrasound guided central venous catheter insertion is expected to be lower than the standard blind technique

  6 months from october 2021 to april 2022

Study Arms (2)

the standard blind technique for Central venous catheter insertion into the internal jugular vein.

using the blind experience based technique without imaging guidance

ultrasound guided technique for Central venous catheter insertion into the internal jugular vein.

using real time ulrasound guidance

Device: ultrasound guided central venous catheter insertion

Interventions

ultrasound guided central venous catheter insertion DEVICE

Prospective comparative randomized controlled clinical study.

ultrasound guided technique for Central venous catheter insertion into the internal jugular vein.

Eligibility Criteria

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

Study Population

Patients will be selected from emergency hospital at zagazig university hospitals who needed CVC insertion as an important part of management plan.

You may qualify if:

• Patient acceptance (if conscious)
• Aged \>18years.
• Gender: both.
• \. Patients admitted to emergency hospital units, at emergency room (ER), operation theater (OT) or emergency intensive care unit (ICU)

You may not qualify if:

• Patient refusal
• Coagulopathy: INR\>1.5 or platelet count\<500000/cc
• Skin infection at site of insertion
• Physician not well trained on utilization of ultrasound machine or even not familiar with it.
• History of surgical manipulation or trauma at the insertion site
• Trauma to other structures (e.g. cervical spine collar is a soft contraindication to an IJ central venous catheter (CVC) placement, a pelvic binder is a contraindication to a femoral CVC placement)

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

ZagazigU

Zagazig, 055, Egypt

Location

Study Officials

• ahmed B mohamed, MD

  Zagazig University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anethesia and icu faculty of medicine zagazig university

Study Record Dates

• First Submitted: April 8, 2022
• First Posted: April 21, 2022
• Study Start: October 20, 2021
• Primary Completion: March 30, 2022
• Study Completion: April 5, 2022
• Last Updated: April 21, 2022

Record last verified: 2022-04

Locations

EG (1)