http://doi.org/10.33698/NRF0118 -Ruche Saini,Meenakshi 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.
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 reported 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; obstruction 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 bio- chemical 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 intervention upon the first signs and symptoms of infiltrations and phlebitis is critical to the prevention of potentially serious adverse outcomes9. Literature recommended 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 inserted 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 8am- 8pm).
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 filled- up by reviewing the fluid and treatment records of the patient. However, if it was absent, the date, time and reason for the removal of the peripheral intravenous cannula were documented and follow-up was terminated.
The data was then transferred into SPSS 15.0 Evaluation Version and was analyzed using descriptive and inferential statistics.
Results
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, 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.
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 follow- up of these could not be done (Table 1).
Table-1: Distribution of after effects and related incidents of peripheral intravenous cannulae N=168
After Effects and Related Incidents of PIC n(%)
| Infiltration | 53 (31.5) | |
| (n=53) | Grade I | 6 (11.0) |
| Grade II | 38 (72.0) | |
| Grade III | 6 (11.0) | |
| Grade IV | 3 ( 6.0) | |
| Phlebitis | 50 (29.8) | |
| (n=50) | Grade I | 2 ( 4.8) |
| Grade II | 23 (46.0) | |
| Grade III | 22 (44.0) | |
| Grade IV | 3 ( 6.0) | |
| Others | 51 (30.4) | |
| Drop-Out | 14 ( 8.3) |
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)
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 | Phlebitis | Other | Total | X2 test | |
| n(%) | n(%) | n(%) | (N) | value | ||
| *p value | ||||||
| TIME | ||||||
| Morning | 26 (35.6) | 15 (20.6) | 32 (43.8) | 73 | 14.37, df=4 | |
| Evening | 18 (32.7) | 13 (23.6) | 24 (43.7) | 55 | p= 0.006* | |
| Night | 09 (22.5) | 22 (55) | 09 (22.5) | 40 | ||
| PLACE | ||||||
| Emergency Medical OPD | 22 (22.9) | 34 (35.4) | 40 (41.7) | 96 | 8.21, df=2 | |
| Emergency Surgical OPD | 31 (43.1) | 16 (22.2) | 25 (34.7) | 72 | p= 0.016* | |
| PERSON
Age** |
||||||
| <30 yrs | 13 (27.7) | 18 (38.3) | 16 (34.0) | 47 | 16.47, | |
| 30-40 yrs | 13 (38.2) | 11 (32.4) | 10 (29.4) | 34 | df=6 | |
| 40-50 yrs | 12 (38.7) | 07 (22.6) | 12 (38.7) | 31 | p= 0.011* | |
| >50 yrs | 15 (26.8) | 14 (25.0) | 27 (48.2) | 56 | ||
| Sex | ||||||
| Males | 41 (32.2) | 42 (33.1) | 44 (34.7) | 127 | 4.22, df=2 | |
| Females | 12 (29.3) | 08 (19.5) | 21 (51.2) | 41 | p= 0.121 | |
| Disease condition | ||||||
| Medical conditions | 22 (22.9) | 34 (35.4) | 40 (41.7) | 96 | 8.18, df=2 | |
| Surgical conditions | 31 (43.1) | 16 (22.2) | 25 (34.7) | 72 | p= 0.016* | |
| Co morbidities | ||||||
| Present | 15 (25.4) | 24 (40.7) | 20 (33.9) | 59 | 5.5, df=2 | |
| Not present | 38 (34.9) | 26 (23.9) | 45 (41.2) | 109 | p= 0.063 | |
| Consciousness level | ||||||
| GCS >10 | 42 (30.6) | 42 (30.6) | 53 (38.8) | 137 | 1.21, df=2 | |
| GCS < 10 | 11 (35.5) | 08 (25.8) | 12 (38.7) | 31 | p= 0.55 | |
**(Mean = 44.38 years + 17.3, Range = 18-88 years)
Table 3: Distribution of after effects and related incidents of peripheral intravenous cannulae as per cannula characteristics N=168
| Variable | Infiltration | Phlebitis | Other | Total | X2 test |
| n(%) | n(%) | n(%) | (N) | value | |
| *p value | |||||
| Cannula size | |||||
| 16 G | 01 (16.7) | 02 (33.3) | 03 (50.0) | 06 | 2.309, df=4 |
| 18 G | 36 (36.0) | 29 (29.0) | 35 (35.0) | 100 | p=0.679 |
| 20 G | 16 (25.8) | 19 (30.6) | 27 (43.5) | 62 | |
| Contact time for antiseptic (in seconds) | |||||
| < 5 s | 25 (35.7) | 22 (31.4) | 23 (32.9) | 70 | 2.82, df=4 |
| 5-10 s | 21 (27.3) | 21 (27.3) | 35 (45.4) | 77 | p=0.588 |
| >10 s | 07 (33.3) | 07 (33.3) | 07 (33.3) | 21 | |
| Insertion site | |||||
| Forearm | 24 (38.1) | 22 (34.9) | 17 (27.0) | 63 | 11.62, df=4 |
| Hand | 29 (27.3) | 29 (27.3) | 48 (45.4) | 105 | p=0.020* |
| Joint Involvement | |||||
| No | 22 (55.0) | 07 (17.5) | 11 (27.5) | 40 | 6.55, df=2 |
| Yes | 31 (24.2) | 43 (33.6) | 54 (42.2) | 128 | p=0.038* |
| Type of joint Involved | |||||
| Elbow | 21 (30.0) | 29 (41.4) | 20 (28.6) | 70 | 8.02, df=2 |
| Wrist | 10 (29.4) | 14 (24.1) | 34 (46.5) | 58 | p=0.018* |
| Difficulty in insertion | |||||
| Yes | 15 (42.9) | 05 (14.2) | 15 (42.9) | 35 | 5.55, df=2 |
| No | 38 (28.6) | 45 (33.8) | 50 (37.6) | 133 | p=0.062 |
| Securement device | |||||
| Dynaplast | 29 (40.3) | 17 (23.6) | 26 (36.1) | 72 | 6.74, df=2 |
| Leukoplast | 24 (25.0) | 33 (34.4) | 39 (40.6) | 96 | p=0.034* |
| Flush | |||||
| Yes | 34 (47.2) | 15 (20.8) | 23 (31.9) | 72 | 14.67, df=2 |
| No | 19 (19.8) | 35 (36.5) | 42 (43.8) | 96 | p=0.00* |
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
| Variable | Infiltration n(%) | Phlebitis n(%) | Other n(%) | Total (N) | X2 test value
*p value |
| Status of dressing of the cannula
Clean |
06 (17.6) |
05 (14.7) |
23 (67.7) |
34 |
19.05, |
| Soiled | 36 (34.9) | 40 (38.8) | 27 (26.3) | 103 | df=2,p=0.00* |
| Total Volume infused
<1000 ml |
10 (33.3) |
09 (30.0) |
11 (36.7) |
30 |
63 |
| 1000-2000 ml | 09 (21.4) | 05 (11.9) | 28 (66.7) | 42 | df = 4 |
| > 2000 ml | 23 (35.4) | 31 (47.7) | 11 (16.9) | 65 | p = 0.00 |
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.
Table 5: Distribution of after effects and related incidents at peripheral intravenous cannula as per the fluids and medications
| Fluids & Medications | Infiltration | Phlebitis | Other | Total |
| n(%) | n(%) | n(%) | (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)
| I/V infusion set | Frequency | Cumulative | Frequency | Cumulative |
| usage | n(%) | n(%) | 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) |
Duration of Infiltration (n=40) Phlebitis (n=41)
The duration of cannula placement ranges from 0-5 days with mean duration of cannula placement 1.96 days + 1.47 SD. The study reported 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 undertaken 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 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 disfigurement11. 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 intervention 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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