NCT01975974

Brief Summary

Obtaining peripheral vascular access in medical patients is a necessary procedure for many healthcare providers. Peripheral vascular access is traditionally performed using palpation or visual inspection to identify appropriate points of entry in the vasculature after which a needle and catheter are threaded through the skin and surround fascia into the vessel of interest. This procedure, one of the most common procedures in the medical field including both artery and vein access, is not 100% successfully attempted. Operator skill heavily influences peripheral vascular cannulation. (Frisch et al. 2013) However, certain patient populations have difficult peripheral vessels to identify by palpation or visual inspection and past operators would be forced to perform the procedure blind based on anatomical landmarks. Recently, to aid vascular identification and increase cannulation success, a number of alternative techniques for peripheral vascular access have been described including ultrasound-guided. Ultrasound-guided vascular access has been utilized in vascular access with improved success rate. However, even with ultrasound guidance the first attempt success rate of cannulation was only approximately 65%. A proposed failure of ultrasound guided peripheral vascular access is most likely due to failure to advance the catheter into the vessel even the vessel was successfully punctured. The investigators propose a specific technique and the positive "Target Sign" as a means to obtain almost 100% successful peripheral vascular access. The investigators plan to enroll 100 surgical patients in the above study and study procedures will not differ from what a patient in the operating room under the care of anesthesia faculty would receive. The above study is simply a way to identify the steps regarding a specific technique.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 2, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 5, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

December 20, 2016

Completed
Last Updated

May 30, 2017

Status Verified

April 1, 2017

Enrollment Period

1.9 years

First QC Date

August 2, 2013

Results QC Date

October 26, 2016

Last Update Submit

April 28, 2017

Conditions

Keywords

vascularaccessultrasound

Outcome Measures

Primary Outcomes (1)

  • Successful First Attempt Peripheral Venous Cannulation

    we will compare the first attempt success rate using proposed ultrasound technique in total of 100 obese (BMI\>30) surgical patients with existing published data. Mata-analysis of first attempt success rate using ultrasound for intravenous cannulation is 61.8% We predict 90% (50% improvement) success rate using the proposed ultrasound technique. Based on this prediction, a sample size of 100 patients provided more than 90% power to compare there two groups at the 0.05 significance level with a two-sided Chi square test.

    one day

Study Arms (1)

Ultrasound

Ultrasound guided peripheral vascular access

Device: Ultrasound

Interventions

Using ultrasound as a guide for peripheral venous cannulation in obese patients

Ultrasound

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will be surgical patients requiring peripheral intravenous access.

You may qualify if:

  • morbid obese surgical patients requiring large bore IV.
  • no visible intravenous access in upper arm

You may not qualify if:

  • \) No target vein by US screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Iowa Hosptials and Clinics

Iowa City, Iowa, 52242, United States

Location

Related Publications (1)

  • Ueda K, Hussey P. Dynamic Ultrasound-Guided Short-Axis Needle Tip Navigation Technique for Facilitating Cannulation of Peripheral Veins in Obese Patients. Anesth Analg. 2017 Mar;124(3):831-833. doi: 10.1213/ANE.0000000000001653.

MeSH Terms

Conditions

ObesityVascular Diseases

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Results Point of Contact

Title
Dr. Kenichi Ueda
Organization
University of Iowa Hospitals and Clinics

Study Officials

  • Kenichi Ueda, MD

    University of Iowa

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor

Study Record Dates

First Submitted

August 2, 2013

First Posted

November 5, 2013

Study Start

July 1, 2013

Primary Completion

June 1, 2015

Study Completion

November 1, 2015

Last Updated

May 30, 2017

Results First Posted

December 20, 2016

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

we are not planning on sharing the data

Locations