Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000588594
Ethics application status
Approved
Date submitted
22/05/2015
Date registered
4/06/2015
Date last updated
14/06/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Development of a clinical prediction rule to improve peripheral intravenous cannulae first attempt success in the Emergency Department and reduce post insertion failure rates. An investigation of Vascular Access Decisions in the Emergency Room: The VADER study.
Scientific title
Evaluating risk factors for peripheral intravenous cannula (PIVC) insertion failure among Emergency Department clinicians performing PIVC insertion in adult patients and effect on first-time insertion success and PIVC dwell time: The VADER study.
Secondary ID [1] 286645 0
Nil Known
Universal Trial Number (UTN)
U1111-1169-8830
Trial acronym
The VADER Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral intravenous cannula insertion failure 294972 0
Peripheral cannula failure as a result of phlebitis 295227 0
Peripheral cannula failure as a result of infiltration/extravasation 295228 0
Peripheral cannula failure as a result of pain 295229 0
Peripheral cannula failure as a result of accidental dislodgement. 295230 0
Peripheral cannula failure as a result of securement device failure 295231 0
Condition category
Condition code
Infection 295232 295232 0 0
Studies of infection and infectious agents
Skin 295233 295233 0 0
Other skin conditions
Surgery 295234 295234 0 0
Surgical techniques

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
12-24
Target follow-up type
Hours
Description of intervention(s) / exposure
The study proposes to determine the factors surrounding peripheral intravenous cannula (PIVC) insertion to identify best practices to promote first-time insertion success, and reduce repeat PIVC insertion for patients admitted to the hospital wards.
A prospective observational study of clinicians performing PIVC insertion in a patient population presenting to ED, with follow-up of any subsequent admissions to hospital wards. Observations include the insertion of PIVC in ED. Patients who are admitted with the observed ED PIVC will be followed up and observed daily until the ED PIVC is removed. All observations and questions we propose are underpinned by scientific literature and have undergone face and content validity indexing.
Intervention code [1] 291787 0
Not applicable
Comparator / control treatment
This is an observational study, there is no comparison or control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 294986 0
First-time insertion success is the primary outcome and will be recorded as a dichotomous variable, either yes or no. PIVC insertion failure is the outcome of interest for analysis along with associated risk factors, which will be identified using regression techniques.
Timepoint [1] 294986 0
At the point of a PIVC insertion attempt in ED. The time when the ED PIVC is removed in admitted patients. The rationale for removal will be recorded.
Primary outcome [2] 294988 0
Predictors of survival time of an ED inserted PIVC
Timepoint [2] 294988 0
Upon study completion at data analysis stage.
Secondary outcome [1] 314511 0
Rates of unnecessary PIVC placement
Timepoint [1] 314511 0
Data analysis phase
Secondary outcome [2] 315045 0
A clinical prediction rule for first-time insertion success
Timepoint [2] 315045 0
After data analysis along with multivariate logistic regression modelling and sensitivity and specificity with a receiver operating characteristics curve.
Secondary outcome [3] 324799 0
Risk factors for insertion failure
Timepoint [3] 324799 0
Upon ward follow up until the ED placed PIVC is removed

Eligibility
Key inclusion criteria
All clinical staff who place PIVCs as part of their role in the Emergency Department, and who consent to participate.
All patients >18 years will be approached. We will attempt to observe all patient types and as such a waiver of consent has been granted. However, patients with the capacity to understand what the researchers are doing will be verbally informed as to what we intend to observe. Family members present with patients who do not have the capacity to understand will also be informed. If either the patient or family members advocating on behalf of a patient decline to have a PIVC procedure observed, they will not be coerced into taking part.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients under 18 years of age. Clinician participants who decline to provide consent. Patients with the capacity to understand and decline to take part and/or family advocating for patients who decline on the patient's behalf.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Our pilot study resulted in a successful first attempt rate of
approximately 86%. Using the guidelines suggested in Peduzzi et al [1], with a sample size of 1000, we would have sufficient numbers to allow us to adequately investigate using multivariate logistic regression approximately 10 variables.
Univariate and multivariate/able logistic regression will be used to determine those variables that are predictors of first time insertion success. Univariate analysis will be conducted initially and factors that are significant at the 0.1 level entered into a multiple regression model. A significance level of 5% will be used to determine statistically significant predictors. Odds ratios and 95% confidence intervals will be provided for a final model. Diagnostic measures will be calculated and receiver operating characteristic (ROC) curves constructed, with the area under the curve (AUROC) calculated to quantify the overall prognostic discrimination for first-time insertion success. Analyses for secondary aims will include Cox proportional hazards models and will include; Time zero (T0):IV insertion, Time of event (T1): PIVC failure, Time censored (T2): PIVC removal or transfer to other hospital. Kaplan-Meier survival curves will identify the survival time of ED inserted PIVC.

1. Peduzzi, P., Concato, J., Kemper, E., Holford, T. R., & Feinstein, A. R. (1996). A simulation study of the number of events per variable in logistic regression analysis. Journal of Clinical Epidemiology, 49(12), 1373–9. Retrieved from http://www.ncbi.nlm.nih.gov/pubmed/8970487

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/06/2015
Actual
19/06/2015
Date of last participant enrolment
Anticipated
Actual
11/05/2016
Date of last data collection
Anticipated
Actual
Sample size
Target
1000
Accrual to date
Final
975
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 3751 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [2] 5976 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 9630 0
6009 - Nedlands
Recruitment postcode(s) [2] 13397 0
6150 - Murdoch
Recruitment postcode(s) [3] 13398 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 291218 0
University
Name [1] 291218 0
Griffith University
Country [1] 291218 0
Australia
Funding source category [2] 291388 0
Commercial sector/Industry
Name [2] 291388 0
Becton Dickinson
Country [2] 291388 0
United States of America
Primary sponsor type
Hospital
Name
Sir Charles Gairdner Emergency Medicine
Address
Emergency Medicine Faculty of Medicine, Dentistry, and Health Sciences M516,2nd Floor, R BLock, QEII,Medical Centre, NEDLANDS WA 6009
Country
Australia
Secondary sponsor category [1] 289897 0
University
Name [1] 289897 0
Griffith University
Address [1] 289897 0
NHMRC Centre for Research Excellence in Nursing Interventions, Menzies Health Institute Queensland, Griffith University, Nathan campus, 170 Kessels Road, Nathan, Queensland 4111 Australia.
Country [1] 289897 0
Australia
Secondary sponsor category [2] 289898 0
University
Name [2] 289898 0
The University of Western Australia
Address [2] 289898 0
Emergency Medicine Faculty of Medicine, Dentistry, and Health Sciences M516,2nd Floor, R BLock, QEII,Medical Centre, NEDLANDS WA 6009
Country [2] 289898 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292781 0
Sir Charles Gairdner Group Human Research Ethics Committee
Ethics committee address [1] 292781 0
Ethics committee country [1] 292781 0
Australia
Date submitted for ethics approval [1] 292781 0
Approval date [1] 292781 0
24/04/2015
Ethics approval number [1] 292781 0
2014-138

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 56558 0
Mr Peter J. Carr
Address 56558 0
Emergency Medicine, School of Primary, Aboriginal and Rural Health Care, Faculty of Medicine, Dentistry
and Health Services, M516,2nd Floor, R Block, QEII, Medical Centre, NedlandsUniversity of Western Australia, Nedlands, Australia. WA 6009
Country 56558 0
Australia
Phone 56558 0
+61893464356
Fax 56558 0
Email 56558 0
[email protected]
Contact person for public queries
Name 56559 0
Peter J. Carr
Address 56559 0
Emergency Medicine, School of Primary, Aboriginal and Rural Health Care, Faculty of Medicine, Dentistry
and Health Services, M516,2nd Floor, R Block, QEII, Medical Centre, NedlandsUniversity of Western Australia, Nedlands, Australia. WA 6009
Country 56559 0
Australia
Phone 56559 0
+61893464356
Fax 56559 0
Email 56559 0
[email protected]
Contact person for scientific queries
Name 56560 0
Peter J. Carr
Address 56560 0
Emergency Medicine, School of Primary, Aboriginal and Rural Health Care, Faculty of Medicine, Dentistry
and Health Services, M516,2nd Floor, R Block, QEII, Medical Centre, NedlandsUniversity of Western Australia, Nedlands, Australia. WA 6009
Country 56560 0
Australia
Phone 56560 0
+61893464356
Fax 56560 0
Email 56560 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseDevelopment of a clinical prediction rule to improve peripheral intravenous cannulae first attempt success in the emergency department and reduce post insertion failure rates: The vascular access decisions in the emergency room (VADER) study protocol.2016https://dx.doi.org/10.1136/bmjopen-2015-009196
EmbaseDerivation of a clinical decision-making aid to improve the insertion of clinically indicated peripheral intravenous catheters and promote vessel health preservation. An observational study.2019https://dx.doi.org/10.1371/journal.pone.0213923
N.B. These documents automatically identified may not have been verified by the study sponsor.