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Washington Study of AxoTrack-Guided Central Venous Cannulation (WASHCAN)

Primary Purpose

Hypotension

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AxoTrack System
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hypotension focused on measuring undifferentiated hypotension, central venous cannulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Harborview Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

AxoTrack System guided CVC insertion

CVC insertion guided by landmark

Arm Description

AxoTrack System guided CVC

Anatomical landmarks to guide CVC

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 19, 2017
Last Updated
October 25, 2022
Sponsor
University of Washington
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1. Study Identification

Unique Protocol Identification Number
NCT03027323
Brief Title
Washington Study of AxoTrack-Guided Central Venous Cannulation
Acronym
WASHCAN
Official Title
Washington Study of AxoTrack-Guided Central Venous Cannulation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Study not funded; no participants enrolled
Study Start Date
February 10, 2017 (Anticipated)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Central venous cannulation (CVC) is commonly performed to give volume resuscitation and parenteral medications to patients with time sensitive conditions such as severe traumatic injury or undifferentiated shock. CVC via the subclavian route is associated with more frequent technical complications but less frequent infection or thrombosis as compared with via the internal jugular or femoral veins. Traditionally CVC via the subclavian vein is guided by anatomical landmarks. CVC guided by real-time use of traditional diagnostic ultrasound device is associated with a lower technical failure rate (overall and on first attempt), fewer punctures, faster access, and fewer mechanical complications as compared with guidance by anatomical landmarks when performed via the internal jugular vein. It remains unclear whether CVC guided by real-time ultrasound is associated with significantly lower failure and complication rates as compared with CVC guided by landmarks when performed via the subclavian vein. CVC guided by real-time ultrasound may reduce the incidence of complications, number of punctures, and the time between skin penetration and the aspiration of venous blood into the syringe as compared with guidance by landmarks. A limitation of guidance by a traditional diagnostic ultrasound device is it that it may require an assistant to perform, which may not be feasible when treating time sensitive conditions or in low resource settings. In addition, most traditional ultrasound probes are not designed to image the subclavian vein behind the clavicle. The AxoTrack system is a novel ultrasound guidance system recently cleared for human use by the United States Food and Drug Administration. It is intended to facilitate 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. It remains unclear whether CVC guided by AxoTrack reduces procedure times and complication rates when compared with CVC using landmark guidance in patients with undifferentiated hypotension.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension
Keywords
undifferentiated hypotension, central venous cannulation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AxoTrack System guided CVC insertion
Arm Type
Other
Arm Description
AxoTrack System guided CVC
Arm Title
CVC insertion guided by landmark
Arm Type
No Intervention
Arm Description
Anatomical landmarks to guide CVC
Intervention Type
Device
Intervention Name(s)
AxoTrack System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time to insertion of CVC into a subclavian vein
Description
The time it takes for the care provider to insert the central venous cannulation device into the subclavian vein
Time Frame
0-30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Confirmed systolic blood pressure < 90 mmHg in emergency department; Aged at least 18 years; and Need for CVC in emergency department. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Graham Nichol, MD, MPH
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Washington Study of AxoTrack-Guided Central Venous Cannulation

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