Washington Study of AxoTrack-Guided Central Venous Cannulation

NCT03027323 | Withdrawn FDA Device

• 1 other identifier: STUDY00000958
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Undifferentiated hypotension is a medical emergency where a patient's blood pressure drops to critical levels due to several possible reasons. The medical staff treating the patient will need to find out the reason for your drop in blood pressure as soon as possible. When treating low blood pressure, the medical staff typically performs a procedure called central venous cannulation (CVC). CVC involves accessing a large vein (usually the subclavian under the collarbone) by inserting a needle into the vein. By doing this, the medical staff can measure the pressures in the patient's veins or give medicine to the patient while they are in the hospital. The purpose of this study is to compare the time needed to complete CVC using the AxoTrack device to CVC guided by landmarks on a patient's body. The investigators expect that there will be a maximum of 30 patients enrolled in this study.

Conditions

Hypotension

Keywords

undifferentiated hypotension; central venous cannulation

Outcome Measures

Primary Outcomes (1)

• Time to insertion of CVC into a subclavian vein

  The time it takes for the care provider to insert the central venous cannulation device into the subclavian vein

  0-30 minutes

Study Arms (2)

AxoTrack System guided CVC insertion

OTHER

AxoTrack System guided CVC

Device: AxoTrack System

CVC insertion guided by landmark

NO INTERVENTION

Anatomical landmarks to guide CVC

Interventions

AxoTrack System DEVICE

The AxoTrack system is a novel ultrasound guidance system intended to facilitate central venous cannulation (CVC) by a single operator as well as to reduce complications and time associated with CVC. The AxoTrack has a small ultrasound scan head which facilitates imaging of the subclavian vein.

AxoTrack System guided CVC insertion

Eligibility Criteria

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

You may qualify if:

• Confirmed systolic blood pressure \< 90 mmHg in emergency department;
• Aged at least 18 years; and
• Need for CVC in emergency department.

You may not qualify if:

• Preexisting written do not attempt resuscitation order;
• Prisoners;
• Pregnant;
• ST-elevation on initial 12-lead electrocardiogram;
• Blunt or penetrating traumatic injury;
• Major burn;
• Exsanguination;
• Obese (i.e. estimated body mass index \> 30 kg/m2);
• Known coagulation disorders;
• Contraindication to CVC by subclavian route; or
• Patients in extremis for whom placement of the device would delay emergent care.

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Graham Nichol, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, School of Medicine: General Internal Medicine

Study Record Dates

• First Submitted: January 19, 2017
• First Posted: January 23, 2017
• Study Start: February 10, 2017
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: October 28, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)