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RecruitingNCT04324762DRAUPUpdated Dec 4, 2023

Implementation of Ultrasound Guided Central Venous Catheter Confirmation Protocol

An observational study in Behavior, Process, Acceptance and Inertia of Accommodation, sponsored by Washington University School of Medicine. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-04.

Sponsored by Washington University School of Medicine · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2023, 2 years 9 months ago, but the record still lists the study as recruiting.
  • Started Dec 2019; still recruiting 6 years 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
120
Ages
18 Years and older
Sex
All
01

Study summary

The bedside use of ultrasound after central venous catheter (CVCs) insertion has lagged behind other applications in medicine, thus presenting an opportunity for innovative, evidence-based research that will influence clinician behavior. This research focuses on bedside ultrasound applications as an example, to evaluate clinical practice change. Chest radiographs are associated with delays in initiating time-critical interventions and present an unexamined opportunity for improving patient care by evaluating the use of ultrasound in lieu of chest radiographs after CVC insertion. Strategic interventions for implementation are needed to hasten the adoption of this clinical innovation (ultrasound guided CVC confirmation protocol) allowing them to de-implement chest xrays when no longer indicated.

Read the detailed description

The placement of central venous catheters (CVCs) is a common procedure performed in critically ill patients, with millions placed annually. The routine use of chest radiographs for CVC confirmation is outdated. Chest radiographs are associated with delays in initiating time-critical interventions and present an unexamined opportunity for improving resource utilization and associated costs. Radiography has been used for over 50 years for this purpose in the absence of other options. Emerging evidence suggests that a post-procedure chest radiographs are unnecessary when ultrasound is used to confirm catheter position and exclude pneumothorax (PCEP). Yet few in the medical community are likely aware of these data and even among those who are aware, chest radiographs continues to be the routine modality used for CVC PCEP.

The average 17 years it takes to translate clinical research into practice is too long and presents an opportunity to expedite implementation of innovations in critical care medicine. For the proposed project, "De-Implementation Of Routine Chest Radiographs After Adoption of Ultrasound Guided Insertion and Confirmation of Central Venous Catheter Protocol (DRAUP)", the hypothesis is that identifying determinants of behavior for intervention development (Aim 1) will increase the likelihood of developing successful strategies that will yield faster clinical adoption. Understanding the behavioral adaptations that have to occur is key to developing strategies that increase the uptake of evidence into healthcare practice and improving health outcomes. These strategies (targeting adoption and substitution) will then be implemented in a local Emergency Department (Aim 2) to determine if these selected implementation strategies will increase provider adoption, fidelity, and organizational penetrance (Aim 3) of ultrasound-guided CVC PCEP. A good clinical outcome would be a decrease in provider dependence on chest radiographs after ultrasound-guided CVC PCEP.

02

Conditions studied

  • Behavior
  • Process, Acceptance
  • Inertia of Accommodation

Keywords

  • ultrasound
  • central venous catheter
  • POCUS
  • chest radiography
  • Dissemination & Implementation
  • De-Implementation
03

In context

Lead sponsor

Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.

Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.

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
Yes
Sampling method
Non-probability sample

Study population

Clinical healthcare workers involved in the placement and/or maintenance of central venous catheters (nurses, doctors, administrators)

Inclusion criteria

  • have a clinical role in the placement and maintenance of central venous catheters

Exclusion criteria

Exclusion Criteria:

-

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
120 participants (estimated)
Patient registry
No

Interventions

  • Behavioraltargetted implementation strategies

    strategies at the individual and institutional level to promote implementation of an evidenced based innovation and de-implementation of an unnecessary, low value diagnostic test.

06

What researchers measure

Primary outcomes

  1. Adoption

    Adoption will be measured by calculating the absolute number and proportion who utilize POCUS guided protocol and deimplement chest radiographs after central venous catheter placement

    Time frame: 1 year

  2. De-adoption

    De-adoption will be measured by calculating the absolute number and proportion who do not obtain chest radiographs after central venous catheter placement

    Time frame: 1 year

  3. Fidelity

    Fidelity will be measured by calculating the degree (%) to which the DRAUP algorithm was implemented as it was prescribed

    Time frame: 1 year

Secondary outcomes

  1. Effectiveness

    Effectiveness will be measured by calculating the sensitivity/specificity of POCUS guided CVC confirmation

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • Washington Unversity School Of Medicine
    Saint Louis, Missouri 63110, United States
    Recruiting
08

References and documents

Publications

  • Ablordeppey EA, Powell B, McKay V, Keating S, James A, Carpenter C, Kollef M, Griffey R. Protocol for DRAUP: a deimplementation programme to decrease routine chest radiographs after central venous catheter insertion. BMJ Open Qual. 2021 Oct;10(4):e001222. doi: 10.1136/bmjoq-2020-001222. PubMed 34663588 ↗

Individual participant data

Plan to share: Yes — IPD will be shared via manuscript publication; specific IPDs can be requested by email. All shared data will be in the form of group assessments as to not identify an individual response or behavior pattern.

Supporting information: Study protocol, Sap, Icf

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 4, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04324762
Lead sponsor
Washington University School of Medicine
Responsible party
Sponsor
First posted
Mar 27, 2020
Start date
Dec 9, 2019
Primary completion
Dec 31, 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Dec 4, 2023

Study contacts

Enyo Ablordeppey, MD
Contact
ablordeppeye@wustl.edu
314-362-7021
Richard Griffey, MD
Contact
griffeyr@wustl.edu
314-747-4899
Enyo A Ablordeppey, MD
principal investigator · Washington University School of Medicine

Oversight

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

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