Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05226312 |
| Other study ID # |
OrduSBF |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 8, 2022 |
| Est. completion date |
April 10, 2022 |
Study information
| Verified date |
September 2022 |
| Source |
T.C. ORDU ÜNIVERSITESI |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Phlebitis is an inflammation of the tunica intima layer of the vein. Intravenous
administration of drugs with high pH and osmolarity via a peripheral intravenous catheter
damages the vascular structure, causing the drug to leak out of the vessel and cause
phlebitis. Planning the care of the area where phlebitis occurs is the responsibility of the
nurses. When phlebitis symptoms are seen, the infusion is terminated, the treatment is
continued from another area, the extremity is elevated, and warm application is started.
However, studies in the literature on what, how many degrees, how many times a day, and how
long the warm application should be made are limited. Therefore, this planned thesis study
was designed as a randomized controlled experimental study to determine the effect of warm
wet application in the care of peripheral intravenous catheter-related phlebitis. The study
will be carried out in Ordu University Training and Research Hospital oncology, hematology,
palliative, infection, and obstetrics services. The population of the study will be the
patients with phlebitis symptoms, and the sample will be 70 patients determined by G power
analysis. Volunteer patients with phlebitis symptoms after drug infusion with a peripheral
intravenous catheter will be included in the study. Data will be obtained using the "Patient
Information Form", "Phlebitis Follow-up Form" and "Phlebitis Care Schedule". The patients
included in the study will be divided into experimental and control groups by the
randomization method. A warm wet compress will be applied to the phlebitis developing area of
the patients in the experimental group, three times a day for three days. No intervention
will be made in the control group. The data will be evaluated by using the SPSS 22.0 package
program at a significance level of p<0.05 with a 95% confidence interval, and by Student-t or
Mann-Whitney-U test in independent groups according to their suitability for normal
distribution. It is thought that the results of the study will reduce the symptoms of
phlebitis, guide nurses towards care and increase patient satisfaction.
Description:
Peripheral intravenous (PIV) therapy is the process of injecting fluid directly into the
patient's vein. In cases where fluid and electrolyte balance cannot be achieved in patients
who cannot be fed orally, in the administration of chemotherapy, antibiotics, and other
intravenously administered drugs, intravenous therapy is frequently used in patients followed
at the intensive care level, and fluids are given directly into the bloodstream. Although
peripheral IV therapy has many benefits on the patient, complications such as phlebitis,
infiltration, extravasation, thrombosis, cellulitis, and bloodstream infection may occur. The
occurrence of these complications is related to inadequate catheter care, length and diameter
of the catheter, length of stay in the vein, the substance it is produced, the patient's
vascular structure and position, the type and flow rate of the given fluid, the length of
stay in the hospital, and the individual characteristics of the patient.
Peripheral intravenous catheter complications may develop during catheterization or during
infusion or may occur 24-96 hours after catheter removal. When these complications are
encountered, the duration of the hospital stay of the patient is prolonged, and as a result,
mortality and morbidity rates increase. The incidence of PIV catheter complications in our
country is close to 50%. Among the complications, the most common and the most important
complication is phlebitis. While the incidence of phlebitis is between 24.3% and 31.8%
according to national studies, this rate is between 2.63% and 44% in international studies.
Studies have reported that the incidence of phlebitis is higher in individuals receiving
chemotherapy. Because chemotherapy treatments are usually administered by the PIV route. The
irritant, vesicant, non-vesicant properties of chemotherapy drugs, high pH and osmolarity
levels, and repeated cure treatments damage peripheral veins. In addition, antibiotics,
hypertonic solutions, blood, and nutritional products, and analgesics are risk factors for
the development of phlebitis.
Phlebitis is defined as the inflammation of the tunica intima layer of the vein. Phlebitis
occurs in three ways: mechanical, chemical, and bacterial. Mechanical phlebitis; It is seen
for reasons such as the individual characteristics of the patient, the catheter insertion
site, the catheter type, and number, the material used in the catheter fixation, the length
of time the catheter stays in the vein, the treatment time, the skill of the person inserting
the catheter, the determination of the appropriate vein, the fluid flow rate, the use of
infusion pumps, and the number of drugs given. Chemical phlebitis; It is seen when irritating
drugs are given intravenously in a liquid with a density of 600 mOsm/lt or the pH of the
fluids is less than 5 and greater than 9. Bacterial phlebitis is caused by factors such as
cleaning the area with antiseptic, the frequency of changing the infusion set from the
material on which the catheter is fixed, and the care of the catheter site. Symptoms of
phlebitis are redness, erythema, pain, edema, palpable stiffness along the vein (venous
cord), prominence of the venous line, tenderness, discharge, and warmth. The catheter site
should be followed up with the "Visual Infusion Phlebitis Diagnostic Scale" in terms of these
symptoms. However, in a study conducted by Arpa and Cengiz, it was found that nurses did not
know the scale and had a lack of knowledge. Therefore, not following the catheter site and
not recognizing the symptoms increase the incidence of phlebitis. When one of the symptoms of
phlebitis is observed, the degree of phlebitis should be defined according to the scale and
appropriate nursing interventions should be planned.
In the care of the patient with phlebitis, the infusion should be terminated, the catheter
should be removed, the extremity should be elevated, and a new catheter should be inserted to
continue treatment from another site. The area where phlebitis develops should not be used
for a new catheterization for at least 48 hours. Symptoms such as redness, pain, swelling,
and length of venous cord-shaped hardening in the area where phlebitis develops should be
followed according to the visual phlebitis scale. In addition, it is stated in the literature
that local warm application can be applied to the area with phlebitis symptoms. However,
there is no clear information in the literature regarding when to start local warm
application, its duration, and frequency.
Local warm application is frequently used by nurses to provide dilatation of blood vessels,
to reduce inflammation by increasing oxygen circulation in hypoxic conditions, and for the
non-pharmacological treatment of pain and tenderness. Hot/cold applications can be applied in
two ways, wet or dry. The web application provides a moist environment in the area, increases
blood flow to the area, carries nutrients, leukocytes, and antibodies, and increases the rate
of wound healing. Wet application is more effective than dry application as the heat spreads
rapidly to the deep tissues. However, changing the compresses frequently is important for the
effectiveness of the application, as it causes evaporation with vasodilation and cooling of
the skin.
Thermophore, aquathermic pad, hot or cold gel, hot water bath, ice accumulators, electric
heating pad, and compresses are used for hot or cold applications. In the research to be
conducted, a warm wet compress will be used. Compresses are used to apply local heat.
Compress temperature is brought to the range of 26-34°C (79-93°F) for warm application.
Compresses can be prepared in a wide variety of sizes and allowed to apply a certain
temperature to the body area.
In the literature, it is stated in the literature that in the case of phlebitis, applying
warm wet compresses to the affected area can be used to accelerate the blood flow and to
reduce sensitivity and pain with the effect of tissue healing in the area. However, studies
on this subject are limited. In a study conducted by Annisa et al. (2017) in 36 individuals
aged 1 month to 17 years who developed phlebitis, one group was treated with warm water
(n=16) and the other group (n=16) with 0.9% NaCl 3 to 4 times a day. Compress was applied for
20 minutes. When the phlebitis area was followed 24 and 48 hours later, it was stated that
the degree of phlebitis decreased statistically significantly. In a study conducted by
Hidayah et al. (2017) on 40 individuals aged 17-44 years, it was reported that there was a
statistically significant difference in vessel diameter before and after warm wet application
and reduced phlebitis. In the study of Gauttan and Vati (2016) with 60 individuals, it was
found that wet heat and cold application for 20 minutes every two hours is equally effective
and can be used for the treatment of phlebitis.
The Infusion Nurses Association (IHD) stated that it is very important to reduce the
incidence of phlebitis to 5% and below, to prevent its occurrence, to be recognized early and
to take necessary precautions, or to care about it occurs. Nurses working in clinics such as
oncology, hematology, and palliative where phlebitis is common should have sufficient
knowledge of phlebitis prevention, care, treatment, and practice. Nursing care provided by
following current developments and using evidence-based nursing practices will decrease the
incidence of phlebitis and increase the quality of care. In the literature, it is stated that
warm application can be used in the care of phlebitis. However, it is not specified what the
application will be done with, the temperature and how many times a day it will be done.
Therefore, the aim of this study is to determine the effect of warm wet application in the
care of peripheral venous catheter-related phlebitis.
