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The "Peripheral Access Utilizing Sonographic Evaluation" Study (PAUSE)

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ClinicalTrials.gov Identifier: NCT02360163
Recruitment Status : Withdrawn (No enrollment was achieved)
First Posted : February 10, 2015
Last Update Posted : August 3, 2018
Sponsor:
Information provided by (Responsible Party):
Hackensack Meridian Health

Brief 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.

Condition or disease Intervention/treatment Phase
DIVA Procedure: Traditional Landmark Technique (TLT) Device: ultrasound guided peripheral intravenous access (USGPIVA) Not Applicable

Detailed 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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The "Peripheral Access Utilizing Sonographic Evaluation" Study
Study Start Date : February 2015
Actual Primary Completion Date : January 19, 2017
Actual Study Completion Date : January 19, 2017

Arm Intervention/treatment
Active Comparator: Landmark Technique Attempt
Patients will undergo an additonal TLT attempt
Procedure: Traditional Landmark Technique (TLT)
Experimental: USGPIVA Technique Attempt
Patients will be offered a USGPIVA attempt after two failed attempts using the traditional landmark technique (TLT)
Device: ultrasound guided peripheral intravenous access (USGPIVA)



Primary Outcome Measures :
  1. 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 [ Time Frame: 1 Day ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02360163


Locations
United States, New Jersey
Hackensack University Medical center
Hackensack, New Jersey, United States, 07601
Sponsors and Collaborators
Hackensack Meridian Health
Investigators
Principal Investigator: Nancy Van Buitenen, MSN, APN, RN Hackensack UMC

Responsible Party: Hackensack Meridian Health
ClinicalTrials.gov Identifier: NCT02360163     History of Changes
Other Study ID Numbers: Pro 2921
First Posted: February 10, 2015    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: August 2018