The "Peripheral Access Utilizing Sonographic Evaluation" Study

NCT ID: NCT02360163

Last Updated: 2018-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2017-01-19

Brief Summary

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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.

Detailed Description

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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.

Conditions

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DIVA

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Landmark Technique Attempt

Patients will undergo an additonal TLT attempt

Group Type ACTIVE_COMPARATOR

Traditional Landmark Technique (TLT)

Intervention Type PROCEDURE

USGPIVA Technique Attempt

Patients will be offered a USGPIVA attempt after two failed attempts using the traditional landmark technique (TLT)

Group Type EXPERIMENTAL

ultrasound guided peripheral intravenous access (USGPIVA)

Intervention Type DEVICE

Interventions

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Traditional Landmark Technique (TLT)

Intervention Type PROCEDURE

ultrasound guided peripheral intravenous access (USGPIVA)

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hackensack Meridian Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nancy Van Buitenen, MSN, APN, RN

Role: PRINCIPAL_INVESTIGATOR

Hackensack UMC

Locations

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Hackensack University Medical center

Hackensack, New Jersey, United States

Site Status

Countries

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United States

References

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Tada M, Yamada N, Matsumoto T, Takeda C, Furukawa TA, Watanabe N. Ultrasound guidance versus landmark method for peripheral venous cannulation in adults. Cochrane Database Syst Rev. 2022 Dec 12;12(12):CD013434. doi: 10.1002/14651858.CD013434.pub2.

Reference Type DERIVED
PMID: 36507736 (View on PubMed)

Other Identifiers

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Pro 2921

Identifier Type: -

Identifier Source: org_study_id

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