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8 / Bri Brief resume of the intended work
6.1. Need for the study
Patients are admitted to ICU for various ailments and all these clients require parental infusions for medication as well as nutrition. Peripheral intracathline are frequently required for the critically ill patients. Proficiency in safe and effective catheterization includes not only possession of good skills acquired during supervised practice, but also knowledge of indications, contraindications, advantages, disadvantages, complications, measures to prevent complications, and specific techniques.1
Peripheral intracathlines in India are used very frequently in critically ill patients like cardiac arrest, shock, respiratory arrest, CVA and burns etc, for Intravenous infusion, administration of medication, maintenance of fluid and electrolyte balance etc, and they need to be kept patent for more than a dayor so. But with venous/peripheral cannulation, the incidence of positive catheter culture and associated bacteraemia increases markedly after 2 to 3 days with irritation, pain and discomfort leading to followingproblems like thrombosis at Intravenous site, infiltration, thrombophlebitis etc.2
While caring for clients with peripheral intracathline thrombosis is a very common occurrence in the ICU leading to Phlebitis which occurs more commonly when veins of lower extremity are used.3 Also, the type and size of the catheter, the duration of cannulation and the infusion of hypertonic fluids or various drugsinfluence the occurrence of phlebitis.4The incidence of thrombosis has been shown to range from 0.3 – 71%. 5Thrombosis can be prevented by many ways by flushing the intracathline with:Heparin or Normal saline or Sterile water.
Heparin prevents blood clotting by its antithrombin activity so it is widely used as an anticoagulant in clinical practice.Heparin directly acts on thrombin by suppressing its activity. Heparin also combines with antithrombin III and it removes thrombin from circulation and it inactivates the active form of other clotting factors like IX, X, XI and XII. With the administration of heparin, clients are at risk for impaired comfort such as irritation, pain, or redness at the insertion site and unusual hair loss, allergic reactions, thrombocytopenia, osteoporosis with long term therapy.6
Normal saline is a sterile solution of sodium chloride in purified water containing 0.9 gram of sodium chloride in 100 ml.6After the medication has been administered, the catheter is flushed with an inert isotonic solution such as normal saline. This is done to minimise potential incompatibility problemslike occlusion due to the corrosive and irritating drugs administered through the catheter and preventing stagnation of drugs.
In spite of benefits, complications were also associated with heparin flush and normal saline flush. Through this study the investigator is evaluating the effectiveness of normal saline flush for maintaining the patency of intracath line and to arrive at a definitive line of management for thrombosis of the intravenous site with more benefits and less complications.
6.2. Review of literature
A study conducted to compare effects of Heparinised solution versus Nonheparinised solution for the maintenance of patency of peripheral intracathline among the patients admitted in the medical and surgical wards of Bharati Hospital, Pune. The data collected from 60 medical & surgical patients admitted in the hospital showed thatthere is highly significant association between doses of drug ranged 500-1000 mg in heparinised solution at 72 hrs and resistance [p=0.002],dilution of drug 5ml and resistance [p=0.035] in heparinised solution, dilution of drug 10 ml and resistance [p=0.000]in nonheparinised solution and frequency of drug 6 hourly and resistance [p=0.000] in peripheral intracath line at 72 hrs in both solutions. And it was concluded that “Both the solutions were effective in maintaining the patency of peripheral intracath line and the duration of patency maintained by both solutions was 72 hours. This indicates that both solutions have equal effectiveness in maintaining the patency of peripheral intracath line and there is highly significant association between resistance and age, weight, dose, dilution, frequency and diagnosis, at 72 hrs for the both solutions”. 7
A study conducted in a large academic medical centre in Midwest on the effect of Heparin versus Normal saline for maintenance of peripheral intravenous locks in73pregnant women of which 35 in normal saline group and 38 in heparin group between 24-42 weeks of gestation, hospitalized in the obstetric units. Groups were similar for maternal age, gravidity and parity.The original intent of the study was to measure and compare the outcomes in the two groups within 12, 24, 48 and 72 hrs. However, assessments of iv lock status were rare beyond 12 hrs, generally because of the initiation of fluid infusion. Because there were insufficient data to make comparisons in the 24, 48 and 72 hr groups, only the assessments within 12 hrs for patency are reported. The result showed that of the 35 iv locks flushed with saline, 68.6% had no obstruction within 12 hrs, as compared to no obstruction within 12 hrs in 76.3% of the iv locks flushed with heparin(n=38). This difference in patency was not significant as shown by p=0.459. And it was concluded that there were no statistically significant differences in IV lock patency nor in phlebitis between heparin or normal saline flushes.8
A study was conducted to compare the effect of heparin versus normal saline flush solutions on the duration of patency of peripheral IV catheters of neonates in University of Missouri Columbia Children’s Hospital’s NICU. A quasi experimental design compared the outcomes in 87 infants who were 32 weeks or greater gestation at birth. Thirty three received heparin and 54 received normal saline. In the analysis of all IVC starts, the size of catheter was excluded as a predictor variable because of the low number of 22 gauge catheters used in the sample. The predictor variables of gestational age, site of insertion, type of catheter and additional solution administration (Ampicillin and Gentamicin) were included in analysis, along with the solution used (heparin and normal saline).The findings showed that the mean duration of patency for all IVC starts was 44.4 hours (S.D=29.3). The majority of IVCs were started in the scalp (57%), followed by the hand (18%), arm (13%), foot (9%) and leg (3%). The result shows that no statistically significant difference in duration of patency between IVCs locked with heparin versus normal saline groups. The duration was significantly longer for insertion in scalp, arm or hand than for the leg or foot.9
A study conducted on heparin verses normal saline as a peripheral line flush in maintenance of intermittent intravenous lines in obstetric patients. Researcher hypothesised that in pregnancy use of heparin flushes would improve intermittent IV lock patency, compared with normal saline flushes. Fourty four pregnant women who were between 26 and 34 weeks gestation were included and compared heparin sodium (100 U/ml) with normal saline for use in maintenance of IV locks. Catheter sites were examined and flushed with the study solution at least once every 6 hrs. Partial thromboplastin times were also measured at catheter insertion and 48 hrs later. Although no difference were found in partial thromboplastin times, there was a significant increase in catheter patency rate at 48 and 72 hrs in the heparin group (84% Vs 52% and 68% Vs 27%, respectively; p<0.01). There was also a significantly lower rate of catheter complications in heparin group (13% Vs 31%, p<0.01). 10
A study onefficacy of normal saline solution verses heparin solution for maintaining patency of peripheral intravenous catheters in children at the children’s hospital, Denver, Colorado, USA. The study consisted of 150 emergency department patients with mean age of 5.5 years requiring IV heparin lock placement were included in the sample. Patients were randomised to the control group (n=77) to receive 3 ml of a 10 units heparin/ml normal saline solution IV flush, or to the treatment group (n=73) to receive 3 ml of normal saline solution only for IV flush.For the heparin lock placement in the emergency department the study had a mean and median duration of 2.89 (range: 0.5 – 24 hrs) and 2.5 hrs, respectively. The result suggested that normal saline solution (p<0.01) may be an effective alternative to heparin flush in maintenance of patency in peripheral intermittent IV access devices in the paediatric emergency department. 11
6.3. Statement of the problem
The effectiveness of normal saline flush for maintenance of patency of peripheral intracath line among the patients admitted to ICU of a selected hospital of Mangalore
6.4.Objectives of the study
  • To determine the patency of peripheral intracath line of patients on heparin flush.
  • To determine the patency of peripheral intracathline of patients on normal saline flush.
  • To compare the patency of peripheral intracath line between patients on heparin flush and normal saline flush.
  • To determine the association between the selected variables with the patency of peripheral intracath line.
6.5.Operational Definition
Effectiveness:Effectiveness refers to a change produced by an action or a cause, a result or an out come (Oxford dictionary).12
Effectiveness in this study refers to the extent to which normal saline flush is effective in maintaining patency of intracath line as that of heparin.
Normal saline flush:Normal saline flush is injecting 1-2ml of a sterile solution of 0.9% sodium chloride. It is also known as isotonic sodium chloride solution; normal salt solution; physiological saline; physiological salt solution; physiological sodium chloride solution; sodium chloride solution.6
In this study the normal saline flush indicates injecting 2 ml of normal saline flush into the peripheral intracathline every 12 hrs.
Heparin flush:Heparin flushprevents blood clotting by its antithrombin activity so it is widely used as an anticoagulant in clinical practice.6
In this study heparin flush indicates injecting 10 U/ml into the peripheral intracath line every 12 hrs to maintain patency of intracath line.
Patency: Patency means unobstructed or open (oxford dictionary).12
In this study patency of intracath line means unobstructed or open passage way of the inthracath line as measured by observation check listand Poiseuillie’s law.
6.6. Assumption
  • Patients who are on prolonged intracath line need maintenance of patency of intracath line to prevent occlusion of catheter or vein.
  • Patency of intracathline can be objectively measured.
6.7.Delimitation
  • The study is delimited to patients who are admitted to ICU.
  • Patients who are on intracath line for at least 72 hrs.
6.8.Hypothesis
H1: There will be a significant difference in patency scores of peripheral intracath line of patients on heparin flush and normal saline flush.
H2: There is significant association between selected demographic variables and patency scores of peripheral intracath line.
Material and methods
7.1. Source of data
Patients who are admitted in ICU of selected hospital Mangalore.
7.1.1.Research design
Quasi experimental design ( post test only control group design)
E X O1 O2 O3
C --- O4 O5 O6
E =Experimental group
C = Control group( conventional heparin flush)
X = Treatment withNormal saline flush
O1, O2 and O3= Post test of the experimental groupat 24, 48 and 72 hours.
O4, O5 and O6= Post test of control group at 24, 48 and 72 hours respectively from the time of insertion of intracath line.
7.1.2. Setting
The study will be conducted in the ICU of a selected hospital Mangalore.
7.1.3. Population
Patients who are admitted in the ICU and with intracathline of selected hospital Mangalore.
7.2 Method of data collection
7.2.1Sampling procedure
Sample for the present study will be selected by purposive sampling technique. Then the sample will be randomly assigned into experimental and control group.
7.2.2 Sample size
Forty patients who are admitted in the ICU.
7.2.3Inclusion criteria
-Patients who require intracath line for at least 72 hours.
-Patients willing to participate.
7.2.4 Exclusion criteria
  1. Patients who are sensitive to heparin.
  2. Patients who are on anticoagulant therapy including aspirin.
7.2.5. Instruments intended to be used
  • Observation check list to assess the patency of intracath line.
  • Poiseuille’s law for laminar flow through tubes.
7.2.6. Data collection method
  • Prior to data collection permission will be obtained from the hospital authority concerned for conducting the study.
  • Subjects will be selected according to the selection criteria of the study.
  • Patients in the experimental group is treated with normal saline flush every 12 hrs from the time of insertion of the intracath line.
  • Post testson the experimental group (O1, O2, and O3) and control group (O4, O5 and O6) will be done to assess for patency after 24, 48 and 72 hours respectively.
  • The patency will assessed according to the observation checklist for measuring the patency of intracath line and poiseuille’s law for laminar flow through tubes.
7.2.7. Data analysis plan
Data would be analysed using the descriptive and inferential statistics.
7.3. Does the study require any investigations or intervention to be conducted on patients or other humans or animals?
Yes, Normal saline flush will be used in the experimental group.
7.4. Has ethical clearance been obtained from your institution in case of 7.3?
Yes, ethical clearance will be obtained from the concerned authority.
List of references
  1. Kaye W. Intravenous techniques in text book of advanced cardiac life support. American heart association, Dallas; chapter 12; 1981.
  2. Maki DG, Goldman DA, Rhame FS. Infection control in intravenous therapy; Annals of internal medicine 1973; 79; 867.
  3. Thomas F, Burke JP, Parker J, et al .The risk of infection related to radial verses femoral sites for arterial catheterization Critical care medicine 1983; 11: 807-812.
  4. Charles LS, Ake G. Clinics in critical care medicine. Invasive procedures in critical care; IST edition; 1-48.
  5. Alexander. J. A new and improved guide to IV therapy.
6. Mckenry, Salevno. Mosby’s Pharmacology in Nursing; 21st edition ; Mosby’s
Publication; 622-627.
7. Pramod Sucheta. A comparative study of heparinised solution versus nonheparinised solution for the maintenance of patency of peripheral intracath line among the patients admitted in the medical and surgical wards of Bharati hospital Pune. Journal of Nightingale Nursing times 2006; Page no 28-30.
8. Kathryn M. Niesen, Denise Y. Harris, Linda S. Parkin, Lynn T. Henn. The effect of heparin verses normal saline for maintenance of peripheral intravenous locks in pregnant women. JOGNN clinical research July August 2003; vol 32; page no 503-308.
9. Marilyn Krueger Paislely, Nancy Brown, Maura Stamper, Carry H Ganong, Julie Brown. The use of heparin and normal saline flushes in neonatal intravenous catheters. Paediatric nursing September- October 1997; vol 23; no 5; page no 521-527
10. Meyer BA, Little CJ, Thorp AJ, Cohen GR, Yeaster JD. Heparin verses normal saline as a peripheral line flush in maintenance of intermittent intravenous lines in obstetric patients. Obstetric and Gynaecology 1995; 85; 433-436.
11. Leduc K.Efficacy of normal saline solution versus heparin solution for maintaining patency of peripheral intravenous catheters in children; Journal of emergency nursing 1997; 23(4); 306-309.
12. The concise Oxford Dictionary. Edited by Judy Pearsall; 10th edition; 456, 1044.