This study is a randomized prospective trial comparing US-guided PIVC insertion with standard
PIVC insertion technique. This study will evaluate the predictive strength of
catheter-to-vein ratio to PIVC post insertion success.
The study population is all patients presenting to the ED. The sample population will be
patients requiring a PIVC for treatment or diagnostic purposes and don't have an existing
PIVC (EMS or other). Inclusion and exclusion criteria focusing on most suitable participants
and safety will determine the participant population. Participants will be randomized to one
of two cohorts; 1) PIVC insertion based on standard technique and 2) US-guided PIVC
insertion.
There will be two data collection phases in this study:
Phase one occurs in the emergency department (ED). ED staff will be notified of the study
period, however to minimize bias, details of the study will not be given. Patients in this
phase include those registered in the ED seeking treatment. To identify potential candidates,
the investigator will perform an initial screening by communicating with ED staff. Initial
screenings will be recorded without using any identifying data. When a potential participant
is identified, the investigator will then coordinate with ED staff, approach the candidate
and confirm that they meet inclusion and exclusion criteria. If the patient qualifies for
enrollment, the investigator will review the study purpose including risks and benefits of
enrolling, and have the patient sign the consent form. Randomization will occur after
obtaining consent. Patients will have a PIVC inserted by any qualified Nurse or Medic. The
PIVC will be placed according to the Reading Hospital Peripheral Intravenous Therapy for
Adults guideline. After the PIVC (Standard or US-guided) is inserted, the investigator will
then measure the vein prior to any infusion that could distort vein measurement.
All investigators involved with vein measurement will complete vein measurement training. The
vein size will be measured using one of the following US machines: SonoSite Edge II or
X-Porte each equipped with a 13-6 MHz, 6 cm linear probe (FUJIFILM SonoSite, Inc. Bothell,
WA, USA). The investigator will then record collected data on the phase one data collection
form and place the form in a secure container. A member of the research team will then
collect the completed data collection forms and enter the data in a secured study database.
To limit bias, investigators will not inform the ED staff of the specifics of this study and
will only provide enough information for data to be collected safely and accurately. In the
event that a PIVC could not be successfully inserted according to the randomized technique,
the PIVC will be analyzed in an intention to treat (ITT) format and the participant will
receive vascular access as per the treatment team.
Phase two of data collection is divided into two parts, and participants in this phase
include those that had a PIVC inserted by either randomized method and were subsequently
placed in an observation status, inpatient status or discharged home. Phase two part one
occurs after the PIVC has been removed. Data collection is performed electronically and may
also involve verbal follow up. Trained investigators will obtain an active list of subjects
whose PIVC was removed. Each subject will have a blank phase two part one data collection
form completed in its entirety when possible. Subjects who remain on an inpatient or
observation status will be followed in the electronic health record (EHR). In this study post
insertion failure is identified when any of the following reasons for PIVC removal has been
entered into the participants EHR: leakage, drainage, phlebitis, painful, occluded,
infiltrated, and catheter damage. If more than one of these reasons has been entered, the
investigator will further investigate the EHR to determine the primary reason for removal. If
electronic data is not sufficient and the subject is still hospitalized, the investigator
will attempt to visit the subject for completion of data collection. Completed phase two part
one forms will be placed in a secure container until entry into the study database. Following
data entry, paper forms involved in this part will be destroyed. Subjects with a PIVC that
was removed for a reason not determined as a failure will proceed into phase two part two.
Phase two part two occurs when a PIVC was removed without complication. A trained
investigator will obtain a list of subjects whose PIVC was removed without complication. The
investigator will determine if 48 hours has passed since the removal of the PIVC. If so, a
post removal follow-up interview is performed if the patient is still admitted in the
hospital or a phone interview is conducted if the patient was discharged home. Participant
charts will also be reviewed for any subsequent ED or primary care physician visits related
to PIVC complication(s). The investigator completes the phase two part two data collection
form and places it in a secured container. A time limit of 48 hours to contact the
participant has been set for this study. A member of the research team will then collect the
data collection forms and enter the data in the secured study database.
Statistics and data analysis. Sample size calculation:
The baseline failure rate for post-insertion PIVCs at Reading Hospital is 30%. Our study has
set an a priori improvement of an absolute percentage change of 10% as significant. Using a
single tail change in improvement (alpha = 0.025) with the intervention with an 80% power, we
calculated the number needed for each cohort to be 291 subjects, however we will randomize
for 360 in each cohort for a total of 720 subjects to allow for attrition.
Randomization:
Using the statistical package 'R', a series of random numbers will be generated to allocate
individual patients to groups. This random number series will be validated for randomness
using the 'runs test' available in SPSS. A conservative P value of 0.50 will be used to
determine if the sequence of numbers is random. Randomization will continue until a sequence
with a p-value greater than 0.50 is obtained. Once completed, the random number sequence will
be saved to an Excel file and passed to Reading Hospital researchers for processing.
Data analysis:
Data analysis will occur in two separate phases. First descriptive analysis for all variables
for patients within each group. For this analysis discrete variables will be reported as
count, and percent within each category. For continuous variables statistics will include
mean, minimum and maximum values, standard deviation and median. Significance testing will be
conducted between groups. Discrete variables will use chi-square test and continuous
variables will use group or independent t-test. An a priori p-value of 0.050 will determine
statistical significance between groups.
The second phase of this analysis will include inferential statistics on the comparison
between groups for both primary and secondary outcomes.
The primary outcomes to be compared between the PIVC insertion techniques include:
1. Failure rate (overall and individual cause/reason).
2. Utility time. 3. Catheter-to-vein ratio. For the analysis of failure rate chi-square analysis will be used between the two groups.
Utility time will be analyzed by group t-test. Catheter to vein ratio will be aggregated
among all patients within group and a rate analysis defined by Fleiss will be used to
determine if the ratios between treatment cohorts are significantly different. A standard
p-value of 0.05 will be used for these analyses.
The secondary outcomes will be:
1. Describe post removal complication rates among traditional and US-guided PIVC insertion
techniques. 2. Identifying a catheter-to-vein ratio that predicts complication. The complication rate will be analyzed by standard rate analysis by Fleiss. Complication
rates will be calculated as the number of complication divided by the number of patients.
In order to determine the catheter to vein ratio that may predict a complication, both groups
will be added together in aggregate, and a ROC curve will be calculated using the catheter to
vein ratio as the independent variable and the complication (0, 1) as the dependent variable.
Standard methodology to determine the cutoff point will be used, (diagonal line drawn to ROC
curve then projected down to sensitivity value) to determine the cutoff point. Standard ROC
descriptive statistics will be used including area under the curve, standard error of the
area, 95% confidence interval of the area, p-value as well as sensitivity and specificity of
the cutoff value. The null hypothesis for the ROC curve will be area is equal to 0.50.
Due to the exploratory nature of these analysis there will be no corrections for multiple
comparisons.