1. science
2. medicine
3. surgery

Epidemiology of Infiltration and Phlebitis
Ruchi Saini, Meenakashi Agnihotri, Ashok Gupta, Indarjit Walia
Abstract : The placement of intravascular cannula for administration of fluids, drugs, blood
products and nutritional solutions is one of the most common invasive procedures performed in
hospitals. The insertion and daily use of these devices is associated with risks and complications
that can have impact on the clinical status and outcome of the patient. The present study was thus
undertaken to investigate various risk factors responsible for the infiltration and phlebitis in the
emergency department of Nehru Hospital, PGIMER, Chandigarh. Total of 168 peripheral intravenous
cannulae were included in the study using purposive sampling technique and were studied
prospectively for the after effects of the intravenous therapy and related incidents. The study revealed
incidence of infiltration and phlebitis as 31.5% and 29.8% respectively. It was found that the peripheral
intravenous cannula insertions during morning and night shifts in emergency department to patients
with medical and surgical conditions along with inappropriate aseptic technique during insertion and
handling of cannula, use of forearm as the site of insertion, involvement of elbow joint, soiling of the
cannula dressing, longer duration of cannula placement along with the use of IV infusion sets for
more than 24 hours, administration of large volumes of crystalloids and colloids at high flow rates
and medications such as antibiotics and electrolytes through the peripheral intravenous cannulae
were the most important risk factors for the development of infiltration and phlebitis. The protocol
was developed based on the findings of the study for use by the nurses and other health care
professionals who are involved directly or indirectly in the handling of peripheral intravenous cannula.
Key words :
Peripheral intravenous cannula, infiltration,
phlebitis
Correspondence at :
Ruchi Saini
Lecturer,
Swift College of Nursing,
Vill. Ghaggar Sarai, Teh. Rajpura,
Distt. Patiala, Punjab
Introduction
Each year, millions of patients admitted
in the hospitals require some form of vascular
access as a critical component of their medical
care. Vascular access devices are used for the
hemodynamic monitoring of the patient,
administration of medications, fluids,
nutritional solutions and blood products1.
Nursing and Midwifery Research Journal, Vol-7, No. 1, January 2011
22
The insertion and daily use of these
devices is associated with risks and
complications that can have impact on the
clinical status and outcome of the patient. A
variety of complications associated with the
insertion and the utilization of venous access
devices can be categorized either as local
complications such as thrombosis,
thrombophlebitis, extravasations and
infiltration or systemic complications like
pulmonary embolism and blood stream
infections that occur less frequently than local
complications. Usually they are serious, may
be life threatening and require immediate
medical attention1,2.
Infiltration and extravasations are
known complications of infusion therapy. The
Infusion Nurses Society (INS) and Oncology
Nursing Society defined infiltration as the
inadver tent leakage of a non-vesicant
solution or medication into the tissue
surrounding the I/V catheter whereas
extravasation is the inadvertent leakage of a
vesicant medication or solution into the
surrounding tissue whereas vesicant refers
to any medication or fluid with the potential
for causing blisters, severe tissue injury, or
necrosis3.
The incidence of peripheral vein
extravasation has been repor ted to range
from 0.1% to 6.5% 4. Infiltration and
extravasations can occur due to mechanical
causes such as placement of cannula in areas
of joint flexion, large gauze cannulae and
improper stabilization or splinting of the joint;
obstr uction because of clot formation
following multiple vein punctures and due to
inflammatory processes associated with the
drugs such as cytotoxic agents that promote
venous inflammation by the release of biochemical substances such as histamine,
serotonin, leukotrienes, prostaglandlins, and
bradykinins3.
Phlebitis is the inflammation of the
interior wall of the vein; the tunica intima. It
affects 27% to 70% of all patients receiving
intravenous therapy6. The intravenous Nurses
Society states that the accepted phlebitis rate
is 5% or less in any given population”.
Patient factors that increase risk of
developing phlebitis include increasing age,
female sex6,8, conditions such as neutropenia,
malnutrition, immunosuppression, conditions
that impair circulatory function and peripheral
neuropathy. The basic factors leading to
phlebitis can be broadly divided into
mechanical causes such as catheter size,
catheter material, catheter length, catheter
insertion site, method of immobilization and
the dwell time6; chemical causes such as
infusion of the medications or fluids with
variable pH or osmolality and bacterial causes
due to use of contaminated I/V solution, tubing,
catheter or insertion site and absence of use
of aseptic technique while inser ting the
cannula6 and care and handling by inexpert
clinicians6.
The early identification of risk factors and
inter vention upon the first signs and
symptoms of infiltrations and phlebitis is critical
to the prevention of potentially serious adverse
outcomes 9. Literature recommended
Nursing and Midwifery Research Journal, Vol-7, No. 1, January 2011
23
development of well-established written
protocols followed by close supervision for
the prevention of infiltration and phlebitis.
However, variable nursing practices and lack
of written protocols in the Emergency OPDs
of Nehru Hospital prompted the researcher
to take up the study with the objectives to
determine the incidence and risk factors
predictive of infiltration and phlebitis and to
develop protocol for their prevention in
Emergency OPDs of Nehru Hospital.
Materials and Methods
The study was conducted at Nehru
Hospital, Post-Graduate Institute of Medical
Education and Research (PGIMER),
Chandigarh. It is a ter tiary level teaching
hospital with bed strength over 1600. A
comprehensive emergency depar tment
exists, which caters to medical, trauma and
surgical emergencies round the clock.
The study population comprised of all
the patients admitted in Emergency medical
& Emergency surgical outpatient department,
all the peripheral intravenous cannulae
inser ted to patients and all the nurses &
nursing activities in relation to selected
peripheral intravenous cannulae. Purposive
sampling technique was used and each day
first five patients admitted to Emergency
medical & Emergency surgical outpatient
department were selected over three shift
timings (8am-2pm, 2pm-8pm and 8am8pm).
The tools developed for data collection
included Procedure Observation Sheet which
contained items related to patient
characteristics such as age, sex, disease
condition, co-morbid illness etc.; cannula
characteristics such as cannula size, material,
insertion site, securement device etc., and,
nursing care activities such as hand washing,
use of gloves, skin preparation etc. A
Continuing Care Sheet was also developed by
the investigator for use during subsequent
observations of the patient. Glasgow Coma
Scale was adopted to assess the
consciousness level of the patient. Infiltration
Scale developed by Infusion Nurses Society
(2000) and Jackson’s Phlebitis scale were
adopted to assess infiltration and phlebitis. The
validity of the tools was established by
consultation with the experts from the field of
medicine and nursing. A pilot study was
conducted to assess the feasibility of the study
and relevant modifications were made.
Data collection was done after seeking
approval from the Ethics Review Committee
of PGIMER. Each day first five patients admitted
to emergency medical or emergency surgical
outpatient depar tment were enrolled. An
informed written consent was obtained from
each patient and an informed verbal consent
was obtained from each nurse involved in the
study. Procedure Observation Sheet was
introduced at the time of peripheral intravenous
cannula insertion. Daily follow-up of the patient
was done for the presence or absence of
peripheral intravenous cannula. If the
peripheral intravenous cannula was present,
cannula site was assessed for infiltration and
phlebitis and continuing care sheet was filledup by reviewing the fluid and treatment records
of the patient. However, if it was absent, the
Nursing and Midwifery Research Journal, Vol-7, No. 1, January 2011
24
date, time and reason for the removal of the
peripheral intravenous cannula were
documented and follow-up was terminated.
Results
various renal and GI disorders, leukemia and
respiratory tract infections while 43% of the
patients suffered from surgical conditions
ranging from trauma, neuro-surgical disorders
to oncological conditions. Around 35% of the
patients taken up for the study has one or more
than one co-morbidities such as coronary
artery disease, diabetes mellitus, hypertension,
tuberculosis etc.
A total of 168 patients with 168
peripheral intravenous cannulae (PIC) were
studied. The mean age of the 168 patients
enrolled in the study was 44.38 years + 17.3
with the range between 18-88 years. Around
75% of the patients were males. More than
50% of the patients taken up for the study
were having medical conditions such as
alcoholic liver disease, myocardial infarction,
The study findings reported incidence
of infiltration among cannulae to upto 31.5%.
Majority of the cannulae developed Grade II
(72%) infiltration. Phlebitis developed in 29.8%
of cannulae. Nearly 45% of cannulae developed
each Grade II and Grade III phlebitis. Around
30.4% cannulae remain unaffected by either
of two and 8.3% were dropped out as followup of these could not be done (Table 1).
The data was then transferred into
SPSS 15.0 Evaluation Version and was
analyzed using descriptive and inferential
statistics.
Table-1: Distribution of after effects and related incidents of peripheral intravenous
cannulae
N=168
After Effects and Related Incidents of PIC
Infiltration
(n=53)
Phlebitis
(n=50)
n(%)
Grade I
Grade II
Grade III
Grade IV
53 (31.5)
6 (11.0)
38 (72.0)
6 (11.0)
3 ( 6.0)
Grade I
Grade II
Grade III
Grade IV
50 (29.8)
2 ( 4.8)
23 (46.0)
22 (44.0)
3 ( 6.0)
Others
Drop-Out
Nursing and Midwifery Research Journal, Vol-7, No. 1, January 2011
51 (30.4)
14 ( 8.3)
25
Time, Place and Patient-related factors
The study reported that more than half
of the cannula inser ted during night shift
developed phlebitis while around 35% of the
cannula inser ted during morning shifts
developed infiltration which was found
significant (p= 0.006). The incidence of
infiltration was found to be lowest among
cannulae inserted during night (22.5%) and
that of phlebitis during morning hours
(20.6%).
It was found that one third of the
cannulae inser ted in EMOPD developed
phlebitis in (35.4%) while those inserted in
ESOPD developed infiltration in 43.1%
canulae which was found statistically
significant (p=0.016).
The present study revealed distribution
of after effects and related incidents at
peripheral intravenous cannula as per the
characteristics of person such as age, sex,
disease condition, presence of co-morbidities
and the consciousness level of the patient. It
was repor ted that the age and disease
condition of the patient were significantly
associated (p=0.011, p=0.016) with the
development of infiltration and phlebitis while
gender, presence of co-morbidities and the
consciousness level of the patient did not
show any significant association with the
development of infiltration and phlebitis (Table
2).
Cannula Related Factors
The study repor ted that the size of
cannula used for insertion and the contact
time given to antiseptic for skin preparation
before insertion did not found to have any
impact on the development of infiltration and
phlebitis while the use of forearm as the site
of inser tion of cannula (p=0.020), joint
involvement (p=0.030) and use of elbow joint
(0.018) are significantly associated with the
development of infiltration and phlebitis.
Around 40% of cannulae secured using
dynaplast developed infiltration and 34.4%
cannulae secured using leucoplast developed
phlebitis, the relationship being significantly
associated (p=0.034).
It was found that around 50% of
cannulae flushed after insertion with normal
saline developed infiltration while 36.5%
cannulae not flushed after insertion developed
phlebitis the relationship being significantly
associated (p=0.00). (Table 3)
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Table 2: Distribution of after effects and related incidents of peripheral intravenous
cannulae as per time, place and characteristics of study subjects N=168
Variable
Infiltration
n(%)
Phlebitis
n(%)
Other
n(%)
Total
(N)
X2 test
value
*
p value
Morning
Evening
Night
26 (35.6)
18 (32.7)
09 (22.5)
15 (20.6)
13 (23.6)
22 (55)
32 (43.8)
24 (43.7)
09 (22.5)
73
55
40
14.37, df=4
p= 0.006*
PLACE
Emergency Medical OPD
Emergency Surgical OPD
22 (22.9)
31 (43.1)
34 (35.4)
16 (22.2)
40 (41.7)
25 (34.7)
96
72
8.21, df=2
p= 0.016*
PERSON
Age**
<30 yrs
30-40 yrs
40-50 yrs
>50 yrs
13 (27.7)
13 (38.2)
12 (38.7)
15 (26.8)
18 (38.3)
11 (32.4)
07 (22.6)
14 (25.0)
16 (34.0)
10 (29.4)
12 (38.7)
27 (48.2)
47
34
31
56
16.47,
df=6
p= 0.011*
41 (32.2)
12 (29.3)
42 (33.1)
08 (19.5)
44 (34.7)
21 (51.2)
127
41
4.22, df=2
p= 0.121
Disease condition
Medical conditions
Surgical conditions
22 (22.9)
31 (43.1)
34 (35.4)
16 (22.2)
40 (41.7)
25 (34.7)
96
72
8.18, df=2
p= 0.016*
Co morbidities
Present
Not present
15 (25.4)
38 (34.9)
24 (40.7)
26 (23.9)
20 (33.9)
45 (41.2)
59
109
5.5, df=2
p= 0.063
Consciousness level
GCS >10
GCS < 10
42 (30.6)
11 (35.5)
42 (30.6)
08 (25.8)
53 (38.8)
12 (38.7)
137
31
1.21, df=2
p= 0.55
TIME
Sex
Males
Females
**(Mean = 44.38 years + 17.3, Range = 18-88 years)
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Table 3: Distribution of after effects and related incidents of peripheral intravenous
cannulae as per cannula characteristics
N=168
Infiltration
n(%)
Phlebitis
n(%)
Other
n(%)
Total
(N)
X2 test
value
*
p value
01 (16.7)
36 (36.0)
16 (25.8)
02 (33.3)
29 (29.0)
19 (30.6)
03 (50.0)
35 (35.0)
27 (43.5)
06
100
62
2.309, df=4
p=0.679
Contact time for antiseptic (in seconds)
<5s
25 (35.7)
5-10 s
21 (27.3)
>10 s
07 (33.3)
22 (31.4)
21 (27.3)
07 (33.3)
23 (32.9)
35 (45.4)
07 (33.3)
70
77
21
2.82, df=4
p=0.588
Insertion site
Forearm
Hand
24 (38.1)
29 (27.3)
22 (34.9)
29 (27.3)
17 (27.0)
48 (45.4)
63
105
11.62, df=4
p=0.020*
Joint Involvement
No
Yes
22 (55.0)
31 (24.2)
07 (17.5)
43 (33.6)
11 (27.5)
54 (42.2)
40
128
6.55, df=2
p=0.038*
Type of joint Involved
Elbow
Wrist
21 (30.0)
10 (29.4)
29 (41.4)
14 (24.1)
20 (28.6)
34 (46.5)
70
58
8.02, df=2
p=0.018*
Difficulty in insertion
Yes
No
15 (42.9)
38 (28.6)
05 (14.2)
45 (33.8)
15 (42.9)
50 (37.6)
35
133
5.55, df=2
p=0.062
Securement device
Dynaplast
Leukoplast
29 (40.3)
24 (25.0)
17 (23.6)
33 (34.4)
26 (36.1)
39 (40.6)
72
96
6.74, df=2
p=0.034*
34 (47.2)
19 (19.8)
15 (20.8)
35 (36.5)
23 (31.9)
42 (43.8)
72
96
14.67, df=2
p=0.00*
Variable
Cannula size
16 G
18 G
20 G
Flush
Yes
No
Nursing and Midwifery Research Journal, Vol-7, No. 1, January 2011
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Observations during follow-up period
of peripheral intravenous cannula revealed
that out of 168 peripheral intravenous
cannulae observed during insertion, only 137
peripheral intravenous cannulae were
observed prospectively for various cannula
and nurse related activities. Four teen
cannulae could not be followed because the
patients were either discharged or died within
24 hours of cannula inser tion. Eleven
cannulae developed infiltration and 05
cannulae developed phlebitis within 24 hours
of insertion and thus removed. One peripheral
intravenous cannula was removed by patient
himself.
It was observed that 35% of the cases
were affected with infiltration and phlebitis due
to the soiling of the securement device which
was found statistically significant (p=0.00).
The total volume of fluid infused through the
cannula more than 2000 ml was also found to
have significant association with incidence of
infiltration and phlebitis (p=0.00).(Table 4)
Table 4: Distribution of after effects and related incidents at peripheral intravenous
cannula as per status of cannula dressing and total volume infused
N=137
Infiltration
n(%)
Phlebitis
n(%)
Other
n(%)
Total
(N)
X2 test
value
*
p value
Status of dressing of the cannula
Clean
Soiled
06 (17.6)
36 (34.9)
05 (14.7)
40 (38.8)
23 (67.7)
27 (26.3)
34
103
19.05,
df=2,p=0.00*
Total Volume infused
<1000 ml
1000-2000 ml
> 2000 ml
10 (33.3)
09 (21.4)
23 (35.4)
09 (30.0)
05 (11.9)
31 (47.7)
11 (36.7)
28 (66.7)
11 (16.9)
30
42
65
63
df = 4
p = 0.00
Variable
Table 5 depicts the distribution of after
effects and related incidents at peripheral
intravenous cannula as per the fluids and
medications. It revealed that the
administration of crystalloids such as normal
saline, ringer lactate , dextrose solutions and
antibiotics increase the incidence of infiltration
(33%) and phlebitis (37%) while the cannulae
receiving colloids (61%) and electrolytes
(85.7%) developed phlebitis more frequently.
Nursing and Midwifery Research Journal, Vol-7, No. 1, January 2011
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Table 5: Distribution of after effects and related incidents at peripheral intravenous
cannula as per the fluids and medications
Fluids & Medications
Infiltration
n(%)
Phlebitis
n(%)
Other
n(%)
Total
(N)
Crystalloids
39 (33.3)
40 (34.2)
38 (32.5)
117
Colloids
02 (11.1)
11(61.1)
05 (27.8)
18
Inotropes
03 (60)
-
02 (40)
05
Electrolytes
-
12(85.7)
02 (14.3)
14
Antibiotics
35 (38.9)
33 (36.7)
22 (24.4)
90
Other I/V Drugs
41 (32.3)
44 (34.6)
42 (33.1)
127
Total of 81 cannulae were studied
prospectively to determine the effect of flow
rate of fluid on the development of infiltration
and phlebitis and it was observed that the
cumulative risk for infiltration increased 10
times (from 4 to 40), while that of phlebitis
increased 6 times (from 7 to 41) as soon as
the flow rate of infusion increased above 50
ml/hr. The study also reported the increased
risk for the development of infiltration and
phlebitis with the use of infusion sets for more
than 24 hours. (Table 6).
Table 6: The cumulative risk for infiltration and phlebitis associated with the duration of
I/V infusion set usage among peripheral intravenous cannulae
(N=81)
Duration of
I/V infusion set
usage
Infiltration (n=40)
Frequency
Cumulative
n(%)
n(%)
Phlebitis (n=41)
Frequency
Cumulative
n(%)
n(%)
1 Day
25(62.5)
25(62.5)
15(36.6)
15(36.6)
2 Days
14(35.0)
39(97.5)
08(19.5)
23(56.1)
3 Days
01(2.5)
40(100)
14(34.2)
37(90.3)
4 Days
-
-
04(09.7)
41(100)
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30
The duration of cannula placement
ranges from 0-5 days with mean duration of
cannula placement 1.96 days + 1.47 SD.
The study repor ted that the incidence of
infiltration started increasing from the day of
insertion from 20.8% till it reached 100% on
day 4 with maximum on day 1 (45.3%). It
further reported the increased incidence of
phlebitis from day one of insertion from 10%
to 100% on 5th day with maximum incidence
on 3rd day of insertion (30%).
Nurse and Nursing Activities
Around 85% of the cannulae inserted
by the staff nurses developed infiltration and
phlebitis as compared to 15% of cannulae
inser ted by the nursing student, the
relationship was found statistically
insignificant (p=0.532).
Hand washing was not practiced in any
case of peripheral intravenous cannula
inser tion and subsequently while handling
the peripheral intravenous cannula. While the
use of gloves did not shows any significant
association (p=0.082) with the occurrence
of infiltration and phlebitis.
The most common methods used by
the nurses for the assessment of infiltration
and phlebitis were inspection and palpation.
Discussion
The placement of intravascular cannula
is one of the most common invasive
procedures performed in hospitals. Despite
the many benefits of IV therapy, these
intravascular devices are associated with
wide range of iatrogenic complications
ranging from phlebitis to sepsis to death
leading to prolonged hospitalization and
increased health care cost. The present study
was under taken to investigate various risk
factors responsible for the occurrence of
infiltration and phlebitis and to develop protocol
for their prevention.
Total of 168 patients with 168 peripheral
intravenous cannulae were included in the
study. The mean age of the patients was 44.38
years + 17.3 ranging from 18 to 88 years. In
the present study, the incidence of infiltration
was 31.5% and that of phlebitis was 29.8%.
The present study also revealed the
importance of time and place on the incidence
of infiltration and phlebitis with infiltration more
common in Emergency Surgical OPD during
morning shift hours and phlebitis being more
common in Emergency Medical OPD and
during night hours.
The current study revealed inappropriate
aseptic technique during inser tion and
handling of cannulae, placement of cannulae
on forearm, involvement of the elbow joint,
presence of soiled securement device,
placement of cannula more than 2 days, use
of IV infusion sets for more than 24 hours,
administration of more than 2 liters of
crystalloids (i.e. Normal Saline, 5% Dextrose,
Dextrose-Normal Saline or Ringer lactate) at a
rate more than 50 ml/hr, colloids and
medications such as antibiotics and
electrolytes such as potassium chloride
through the peripheral intravenous cannulae
were the most important risk factors for the
development of infiltration and phlebitis which
Nursing and Midwifery Research Journal, Vol-7, No. 1, January 2011
31
were consistent with the findings of Maki and
Ringer who identified large bore catheters
made of Teflon and inserted in emergency
room, inappropriate disinfection of skin prior
to the inser tion of the catheter, prolonged
duration of catheter placement, use of upper
arm for catheter insertion, high flow rates of
intravenous fluids and the administration of
fluids and medications like low pH solutions,
potassium chloride, hyper tonic glucose,
amino-acids, lipids and antibiotics like
betalactams, vancomycin, metronidazole as
some of the other risk factors identified for
the development of infusion-related
phlebitis10.
The study did not reveal any significant
association between administration of
inotropes and incidence of infiltration and
phlebitis which is found inconsistent with
Dugger B findings who in an observational
study found the peripheral dopamine
infiltration rate of 68% associated with vein
and tissue damage and possible
disfigurement 11 . It may be due to small
number of study sample who received
inotoropes.
The present study repor ted that
duration of cannula placement ranges from
0-5 days with mean duration of cannula
placement 1.96 + 1.47 SD. The incidence
of infiltration and phlebitis was maximum
within 48 hours of cannula placement which
is consistent with the Barker et al randomized
clinical trial which found a significant
reduction in the incidence of infusion phlebitis
with elective change of cannula every 48
hours12.
The study repor ted that out of 53
cannulae which developed infiltration, 88.7%
of cannulae were inser ted by nurses and
11.3% cannulae were inser ted by nursing
student. Literature supported skill in insertion
and the educational level of nurses as important
risk factors for the development of phlebitis13
as was found out in a prospective study by
Palefski and Stoddard 14. The most common
method used by nurses to assess cannula
insertion site for the development of infiltration
and phlebitis was found to be inspection and
palpation.
Apart from the sepsis and pain from the
infiltration and phlebitis related to peripheral
intravenous cannulae, they also cause
increased morbidity and mor tality rates,
increased length of hospitalization, increased
staff workload and increased financial burden
on the patients15. The early identification and
inter vention upon the first signs and
symptoms of infiltration or phlebitis is critical
to the prevention of potentially serious adverse
outcomes. The protocol thus developed based
on the findings of the present study and was
recommended to use by the nurses and other
health care professional who are involved
directly or indirectly in the handling of
peripheral intravenous cannula.
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