Dissections INTERVENTIONAL

20 July 2009
Evidence-based Medicine for Surgeons

Ultrasonographically guided peripheral intravenous cannulation in Emergency Department

patients with difficult intravenous access: a randomized trial
Authors: Stein J, George B, River G, et al
Journal: Annals of Emergency Medicine 2009; 54:33-40
Centre: University of California, San Francisco, USA
Some patients have difficult intravenous access because of obesity, history of intravenous drug
use, chronic illness, or vascular pathology. The use of ultrasonography as an aid to the placement
BACKGROUND of central venous catheters has been well established. Emergency physicians have begun to
explore the use of ultrasonography for the placement of peripheral intravenous catheters.

IN SUMMARY
RESEARCH QUESTION
Venipuncture in difficult intravenous access
Population
US guided No US guidance 'p' 95% CI
A series of patients seen in an
emergency department (during Number 28 31
daytime hours) with difficulty in
Primary end point
establishing intravenous access (2
failed attempts). Number of attempts 2 2 NS
(median)
Indicator variable
Secondary end point
Ultrasound guided venipuncture.
Time to successful 39 mts 26 mts 0.2 -5 - 28
Outcome variable cannulation (median)

Primary: number of attempts Patient satisfaction (Likert 8 7 0.1 0-2

required for successful scale)
cannulation. Secondary: patient
satisfaction and time to successful
cannulation.
Authors' claim(s): “... unable [to] show any difference between an
Comparison ultrasonographically guided group and a non–ultrasonographically guided
group”
Venipuncture without ultrasound
guidance.

THE TISSUE REPORT

Some of us may be aware of an entity known as "Rube Goldberg devices": cartoons showing elaborately complex
mechanical devices that perform simple, day-to-day activities. US guided IV insertion strikes us as being one such. To begin
with, it needs two people, one to show the vein and the other to perform the venipuncture, leave alone the need for a
bedside ultrasound machine. Mercifully, this study showed no advantage to the use of ultrasound in peripheral intravenous
access, although there are many elements in the methodology that are flawed.

EBM-O-METER
Evidence level Overall rating Bias levels
Double blind RCT Sampling
Randomized controlled trial (RCT) Comparison
Trash Swiss Safe News-
Prospective cohort study - not randomized cheese worthy Measurement
Life's too Holds water
short for this Full of holes “Just do it”
Case controlled study
Interestingl | Novel l | Feasible l
Case series - retrospective  Ethical l | Resource saving l

The devil is in the details (more on the paper) ... 

© Dr Arjun Rajagopalan
 SAMPLING
Sample type Inclusion criteria Exclusion criteria Final score card
Simple random  >18 yrs of age  Unstable patients  US guided No US guidance
 2 failed attempts at Requiring
Stratified random Target ? ?
IV access  emergency IV
Cluster  seen during placement  Accessible 68
daytime hours 
Consecutive Intended 28 31
Convenience Drop outs 0 0
Judgmental Study 28 31

 = Reasonable | ? = Arguable |  = Questionable

Duration of the study: June 15, 2005, and August 15, 2005
Sample size determination: 80% power to find an effect size of 1 decreased intravenous attempt with a 2-tailed alpha
of 0.05 and an SD of 1.3. This resulted in 27 patients in each group.

Sampling bias: The study was restricted to patients seen during daytime hours, inducing a significant selection
bias. Nine of 68 eligible patients refused consent for randomization.

COMPARISON
Randomized Case-control Non-random Historical None

Controls - details
Allocation details Of the 20 attending physicians in the ED before the start of the trial, 12 were previously
credentialed in ultrasonography according to American College of Emergency Physicians
(ACEP) guidelines. The remainder of the staff was in the process of credentialing and had
received a 16-hour introductory course 1 year before the start of this study. After this
training, an observational period ensued for 6 months, during which time all physicians had
practice performing this technique. Enrollment of patients began after this training period.
Assignment to a group was individually randomized by a research computer.

Ultrasonographic guidance was performed by the attending emergency physician in real time.
Attending physicians were instructed to use the method they believed would best provide
intravenous access to the patient, as long as they stayed within the study groups. Leg veins
were not allowed, but external jugular placement was allowed.
Comparability The two groups were comparable in terms of demographics, IV drug abuse and comorbidities.
Disparity The US guided group had more significantly obese patients (8 vs 3).

Comparison bias: There were more obese patients in the ultrasound group, a factor to be considered in the light of
the well known difficulty with venipuncture in obese individuals.

MEASUREMENT
Measurement error
Device used Device error Observer error
Gold std.
Repetition

Protocols

Device suited to task

Training

Scoring

Blinding

Y ? N

1.Number of attempts/ time to successful Y N - Y Y N -

cannulation
2. Patient satisfaction (10 point Likert scale) Y N Y Y Y Y -

Trained research assistants were responsible for recording data. An intravenous attempt was defined as 1 percutaneous
needle puncture, without regard to the amount of subcutaneous exploration from that single puncture site. A successful
intravenous attempt was defined as blood return or ability to infuse intravenous fluid without infiltration.
Measurement bias: -

© Dr Arjun Rajagopalan