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CompletedNCT04412967DUSTUpdated Jun 30, 2020

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

An interventional study of Dynamic ultrasound-guided short-axis needle tip navigation and Standard technique of placing a PVC in Overweight and Obesity and Emergencies, sponsored by University Hospital, Linkoeping. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-06-30.

Sponsored by University Hospital, Linkoeping · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years after the study started (first participant enrolled May 2017, registered May 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
89
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Overweight and Obesity
  • Emergencies

Keywords

  • Nurse led
  • Ultrasound
  • Emergency department
  • Overweight
  • Obesity
03

In context

Overweight

3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.

This study's enrollment of 89 is above the median of 73 across 3,175 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

University Hospital, Linkoeping is the lead sponsor of 118 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
89 participants (actual)

Study arms

  • Active comparator
    Standard Technique PVC placement

    Standard PVC placement technique

    Other: Standard technique of placing a PVC

  • Experimental
    DUST

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

    Device: Dynamic ultrasound-guided short-axis needle tip navigation

Interventions

  • DeviceDynamic ultrasound-guided short-axis needle tip navigation

    placement of peripheral venous catheters using ultrasound guided technique

  • OtherStandard technique of placing a PVC

    Standard technique with palpation or Visual inspection of the pvc placement site

06

What researchers measure

Primary outcomes

  1. Time to application

    Application time was defined as the time from applying stasis to visible blood in the PVC flash-chamber.

    Time frame: 1 hour

  2. Number of cannulation attempts

    The total number of cannulation attempts performed per patient

    Time frame: 1 hour

Secondary outcomes

  1. Patient satisfaction

    The perceived satisfaction of the patient as indicated by Numeric Rating scale (NRS, 0 = not satisfied, 10 = maximum satisfaction)

    Time frame: 1 hour

  2. Perceived Pain

    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

07

Study locations

1 site
  • University Hospital Linköping
    Linköping, Östergötland 58185, Sweden
08

References and documents

Study documents

  • Informed consent form · Jun 26, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 30, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04412967
Lead sponsor
University Hospital, Linkoeping
Responsible party
Daniel Wilhelms (Principal Investigator, University Hospital, Linkoeping) — Principal investigator
First posted
Jun 2, 2020
Start date
May 1, 2017
Primary completion
May 16, 2018
Completion
Jun 3, 2018
Last update
Jun 30, 2020

Study contacts

Daniel Wilhelms, Phd
principal investigator · Linkoeping University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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