The "Peripheral Access Utilizing Sonographic Evaluation" Study

DIVA Clinical Trial

— PAUSE  

Official title:

The "Peripheral Access Utilizing Sonographic Evaluation" Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02360163
• Other study ID #: Pro 2921
• Status: Withdrawn
• Phase: N/A
• Start date: February 2015
• Est. completion date: January 19, 2017

Study information

• Verified date: August 2018
• Source: Hackensack University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to reduce, by using the ultrasound guided technique, the minor surgical procedures that might be required to deliver fluids into the blood of critically ill patients simply because the patients' veins cannot be located through the manual technique.

Description:

The purpose of this study is to reduce, by using the ultrasound guided technique, the minor surgical procedures that might be required to deliver fluids into the blood of critically ill patients simply because the patients' veins cannot be located through the manual technique.

The ultrasound assisted technique will increase accessibility to small veins that might be missed via the manual technique. The technique of using an ultrasound machine to assist the administration of fluids into a patient's veins is called ultrasound guided peripheral intravenous access (USGPIVA), while the traditional technique that uses only sight and touch to locate a patient veins without machine assistance is called the traditional landmark technique (TLT). The investigators will compare the effectiveness of USGPIVA with TLT in terms of reducing complications and costs.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 19, 2017
• Est. primary completion date: January 19, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• The patient is >= 21 years of age

• Adult critically ill patients in CCU and MICU requiring short peripheral intravenous access

• The patient has been identified as difficult intravenous access (DIVA), defined as at least two failed blind sticks in the antecubital fossa or more distal upper arm veins

• The patient does not otherwise require a CVC

Exclusion Criteria:

• The patient has a PICC line on the same side as IV placement and has the following:

• Has a condition poses risk for DIC, inadequate flow, or infection.

• Has been identified as a site for "Save the Vein" protocol implementation, unless permission is otherwise obtained by the patient's physician.

• Has a hemodialysis fistula in place on that upper arm side.

• The patient is expected to require therapeutic agent or procedure that necessitates central venous access such as:

• central venous monitoring

• Total Parenteral Nutrition

• Antibiotic requiring central venous access

• Chemotherapy

• Vesicants

• Medications pH less than 5 or more than 9

• Medications of glucose concentrations above 10%

• Solution with protein concentrations above 5% (Vascular Access Management, n.d.)

• The patient already has a central venous catheter access, for reasons other than DIVA, through which therapy can be infused

• The patient has renal disease and a "Save The Vein" order is anticipated or pending (serum creatinine >2mg/dL and GFR <20) for one of the patient's arms, unless permission is otherwise obtained by the patient's physician

• The patient has a bleeding disorder, unless permission is otherwise obtained by the patient's physician

• The clinician believes the patient is not a good fit for the study or that the procedure is not appropriate for patient at the given moment

Related Conditions & MeSH terms

• DIVA

Intervention

Procedure:
• Traditional Landmark Technique (TLT)

Device:
• ultrasound guided peripheral intravenous access (USGPIVA)

Locations

Country	Name	City	State
United States	Hackensack University Medical center	Hackensack	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Hackensack University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in number of minor surgical procedures that may be required to deliver fluids into the blood of critically ill patients by using the ultrasound guided technique		1 Day