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

A Randomized, Controlled Comparison of Nurse-led Placement of Peripheral Venous Catheters in Overweight Patients Using Standard or Dynamic Ultrasound-guided Technique

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.

Study Overview

• Status: Completed
• Conditions: Emergencies; Overweight and Obesity
• Intervention / Treatment: Other: Standard technique of placing a PVC; Device: Dynamic ultrasound-guided short-axis needle tip navigation

• Study Type: Interventional
• Enrollment (Actual): 89
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Östergötland
    • Linköping, Östergötland, Sweden, 58185
      • University Hospital Linköping

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Technique PVC placement; Standard PVC placement technique	Other: Standard technique of placing a PVC; Standard technique with palpation or Visual inspection of the pvc placement site
Experimental: DUST; Dynamic ultrasound-guided short-axis needle tip navigation (DUST)	Device: Dynamic ultrasound-guided short-axis needle tip navigation; placement of peripheral venous catheters using ultrasound guided technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to application	Application time was defined as the time from applying stasis to visible blood in the PVC flash-chamber.	1 hour
Number of cannulation attempts	The total number of cannulation attempts performed per patient	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction	The perceived satisfaction of the patient as indicated by Numeric Rating scale (NRS, 0 = not satisfied, 10 = maximum satisfaction)	1 hour
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

Collaborators and Investigators

• Sponsor: University Hospital, Linkoeping

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Actual): May 16, 2018
• Study Completion (Actual): June 3, 2018

Study Registration Dates

• First Submitted: May 27, 2020
• First Submitted That Met QC Criteria: June 1, 2020
• First Posted (Actual): June 2, 2020

Study Record Updates

• Last Update Posted (Actual): June 30, 2020
• Last Update Submitted That Met QC Criteria: June 26, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Ultrasound; Obesity; Overweight; Emergency department; Nurse led
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Body Weight; Emergencies; Overweight
• Other Study ID Numbers: SE-2020 JG DUST

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No