Assessing Validity of M-Mode Time-to-Turbulence "T2T" Echo Use to Confirm CVC Tip Position

NCT03058445 | Unknown DMC

• 1 other identifier: non
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Using an ultrasound echocardiography , we will measure the time to turbulance "T2T" from injecting saline into the central venous catheter CVC to the appeareance of turbulance on the screen using an MMode. The T2T will be compared with Chest X Ray "CXR" measured distance from the tip of the CVC to the carina. We are trying to evaluate if there is a significant correlation between the two measurements.

Conditions

Central Venous Cather Position

Keywords

Central venous catheter; MMode echocardiography

Outcome Measures

Primary Outcomes (1)

• Correlation between T2T and CVC tip distance to right atrium (RA)

  6 months

Secondary Outcomes (4)

• Correlation between T2T fractioned to the patient's height in meters and CVC tip distance to right atrium (RA)

  6 months

• Correlation between T2T fractioned to the patient's weight in kilograms and CVC tip distance to right atrium (RA)

  6 months

• Comparing the correlation between T2T and CVC tip distance to right atrium (RA) in patients on inotropes to those who are not

  6 months

• Cut-off T2T range in milliseconds that can confirm CVC tip position is in accepted distance in mellimeters to the carina in study population

  6 months

Study Arms (1)

Main group

EXPERIMENTAL

This the only arm in the study Intervention: Echocariography and assessing T2T and CXR CVC tip to carina distance

Device: Echocardiography; Device: CVC

Interventions

Echocardiography DEVICE

Substernal 4 chamber view obtained, then MMode applied to RA, then 5ml of saline is injected

Main group

CVC DEVICE

Injection of 5 ml of saline

Main group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients with CVC in the upper body veins:
• Internal jugular vein (right /left)
• Subclavian vein (right/left)
• CXR completed to confirm CVC position

You may not qualify if:

• \- Patient or personal Consultee refusal
• CVC not in upper body vein
• Inability to obtain subcostal view of RA
• Inability to aspirate blood from distal lumen of CVC

Sponsors & Collaborators

• South Tyneside and Sunderland NHS Foundation Trust: lead

Study Sites (1)

South tyneside hospital

South Shields, Tyne and Wear, ne34 0pl, United Kingdom

RECRUITING

MeSH Terms

Interventions

Echocardiography

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2017
• First Posted: February 23, 2017
• Study Start: January 1, 2017
• Primary Completion: June 1, 2017
• Study Completion: December 1, 2017
• Last Updated: February 23, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)