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

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.

Study Overview

• Status: Withdrawn
• Conditions: DIVA
• Intervention / Treatment: Procedure: Traditional Landmark Technique (TLT); Device: ultrasound guided peripheral intravenous access (USGPIVA)

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
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Hackensack Meridian Health
• Investigators: Principal Investigator: Nancy Van Buitenen, MSN, APN, RN, Hackensack UMC

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): January 19, 2017
• Study Completion (Actual): January 19, 2017

Study Registration Dates

• First Submitted: February 5, 2015
• First Submitted That Met QC Criteria: February 9, 2015
• First Posted (Estimate): February 10, 2015

Study Record Updates

• Last Update Posted (Actual): August 3, 2018
• Last Update Submitted That Met QC Criteria: August 1, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: Pro 2921