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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04412967
Other study ID # SE-2020 JG DUST
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2017
Est. completion date June 3, 2018

Study information

Verified date June 2020
Source University Hospital, Linkoeping
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 89
Est. completion date June 3, 2018
Est. primary completion date May 16, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Dynamic ultrasound-guided short-axis needle tip navigation
placement of peripheral venous catheters using ultrasound guided technique
Other:
Standard technique of placing a PVC
Standard technique with palpation or Visual inspection of the pvc placement site

Locations

Country Name City State
Sweden University Hospital Linköping Linköping Östergötland

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Linkoeping

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to application Application time was defined as the time from applying stasis to visible blood in the PVC flash-chamber. 1 hour
Primary Number of cannulation attempts The total number of cannulation attempts performed per patient 1 hour
Secondary Patient satisfaction The perceived satisfaction of the patient as indicated by Numeric Rating scale (NRS, 0 = not satisfied, 10 = maximum satisfaction) 1 hour
Secondary Perceived Pain The perceived pain of the patient as indicated by Numeric Rating scale (NRS, 0 = no pain, 10 = the worst pain possible) 1 hour
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