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Nurse-led Placement of Peripheral Venous Catheters in Overweight Patients Using Standard or Dynamic Ultrasound-guided Technique (DUST)

Primary Purpose

Overweight and Obesity, Emergencies

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Dynamic ultrasound-guided short-axis needle tip navigation
Standard technique of placing a PVC
Sponsored by
University Hospital, Linkoeping
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight and Obesity focused on measuring Nurse led, Ultrasound, Emergency department, Overweight, Obesity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • REETS prioritization level of "Orange", "Yellow", "Green" or "Blue"
  • 18 years old
  • BMI ≥25 Kg/m2
  • Need of PVC according to Emergency department guidelines
  • Able to give written informed consent

Exclusion Criteria:

  • Unable or unwilling to provide informed consent
  • Life threatening patient status (REETS prioritization level of "Red")
  • Immunosuppression
  • Pregnant or lactating women
  • Blood infections
  • Puncture zone skin damaged (burns, eczema, infection)

Sites / Locations

  • University Hospital Linköping

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Technique PVC placement

DUST

Arm Description

Standard PVC placement technique

Dynamic ultrasound-guided short-axis needle tip navigation (DUST)

Outcomes

Primary Outcome Measures

Time to application
Application time was defined as the time from applying stasis to visible blood in the PVC flash-chamber.
Number of cannulation attempts
The total number of cannulation attempts performed per patient

Secondary Outcome Measures

Patient satisfaction
The perceived satisfaction of the patient as indicated by Numeric Rating scale (NRS, 0 = not satisfied, 10 = maximum satisfaction)
Perceived Pain
The perceived pain of the patient as indicated by Numeric Rating scale (NRS, 0 = no pain, 10 = the worst pain possible)

Full Information

First Posted
May 27, 2020
Last Updated
June 26, 2020
Sponsor
University Hospital, Linkoeping
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1. Study Identification

Unique Protocol Identification Number
NCT04412967
Brief Title
Nurse-led Placement of Peripheral Venous Catheters in Overweight Patients Using Standard or Dynamic Ultrasound-guided Technique
Acronym
DUST
Official Title
A Randomized, Controlled Comparison of Nurse-led Placement of Peripheral Venous Catheters in Overweight Patients Using Standard or Dynamic Ultrasound-guided Technique
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
May 16, 2018 (Actual)
Study Completion Date
June 3, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Linkoeping

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Overweight and obesity may be associated with difficult intravenous access leading to longer procedure time and more placement attempts of peripheral venous catheters (PVC). Dynamic ultrasound-guided short-axis needle tip navigation (DUST) may facilitate the procedure. This was a prospective, randomized, non-blinded study to compare time and placement attempts for nurse-led standard (ST) and ultrasound guided PVC placement in 90 emergency patients with a BMI ≥25kg/m2. Consenting patients were randomized at a 1:1 ratio to receive PVC by either ST or DUST. Application time was defined as the time from applying stasis to visible blood in the PVC flash-chamber. No difference in time was found (medians: ST 42 s; DUST 53.5 s, P = 0.535). There were on average 17 % less placement attempts in the DUST-group (median 1 attempt; Q1 = 1 Q3 = 1) compared to the ST-group (median 1 attempt; Q1 = 1 Q3 = 1.5), (p = 0.031). Patients reported no differences in perceived pain (p = 0.955) or perceived satisfaction (p = 0.342). Pain and subcutaneous infiltrations were the only side-effects reported (ST-group 6, DUST-group 5). DUST does not decrease time to functional PVC but reduces the number of PVC placement attempts in patients with BMI ≥25 kg/m2.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity, Emergencies
Keywords
Nurse led, Ultrasound, Emergency department, Overweight, Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Technique PVC placement
Arm Type
Active Comparator
Arm Description
Standard PVC placement technique
Arm Title
DUST
Arm Type
Experimental
Arm Description
Dynamic ultrasound-guided short-axis needle tip navigation (DUST)
Intervention Type
Device
Intervention Name(s)
Dynamic ultrasound-guided short-axis needle tip navigation
Intervention Description
placement of peripheral venous catheters using ultrasound guided technique
Intervention Type
Other
Intervention Name(s)
Standard technique of placing a PVC
Intervention Description
Standard technique with palpation or Visual inspection of the pvc placement site
Primary Outcome Measure Information:
Title
Time to application
Description
Application time was defined as the time from applying stasis to visible blood in the PVC flash-chamber.
Time Frame
1 hour
Title
Number of cannulation attempts
Description
The total number of cannulation attempts performed per patient
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Patient satisfaction
Description
The perceived satisfaction of the patient as indicated by Numeric Rating scale (NRS, 0 = not satisfied, 10 = maximum satisfaction)
Time Frame
1 hour
Title
Perceived Pain
Description
The perceived pain of the patient as indicated by Numeric Rating scale (NRS, 0 = no pain, 10 = the worst pain possible)
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: REETS prioritization level of "Orange", "Yellow", "Green" or "Blue" 18 years old BMI ≥25 Kg/m2 Need of PVC according to Emergency department guidelines Able to give written informed consent Exclusion Criteria: Unable or unwilling to provide informed consent Life threatening patient status (REETS prioritization level of "Red") Immunosuppression Pregnant or lactating women Blood infections Puncture zone skin damaged (burns, eczema, infection)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Wilhelms, Phd
Organizational Affiliation
Linkoeping University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Linköping
City
Linköping
State/Province
Östergötland
ZIP/Postal Code
58185
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

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Nurse-led Placement of Peripheral Venous Catheters in Overweight Patients Using Standard or Dynamic Ultrasound-guided Technique

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