CHAPTER I
Problem Statement
1.1 Introduction
Home Enteral Nutrition (HEN) is a desired alternative to hospitalization for patients who have a functional gastrointestinal (GI) tract but were unable to meet their nutrient requirements by oral intake. Enteral Nutrition (EN) is a treatment of choice for various conditions when sufficient daily nutrition requirements cannot be met due to dysphagia, malabsorption, or increased energy needs [1].
To ease the administration of feeding, various pumps have been developed that have diverse sizes, mechanisms, settings and purposes. Kangaroo pet®, Kangaroo joey®, and EnteraLite® are Enteral pumps that allow patient mobility and flexibility. Kangaroo Joe® and EnteraLite® are similar in containing non-drip chambers as opposed to kangaroo pet® which contains a drip chamber.
At Loma Linda University Medical Center (LLUMC), EntraLite® was chosen over Kangaroo joey® to replace Kangaroo Pet®. The decision to use EntraLite® was simply because it is smaller, lighter (0.7 lb less than kangaroo joey®), quieter and its rechargeable battery lasts longer than Kangaroo joey's® battery. An important factor in the decision process was that EntraLite® is superior for children in particular because it can operate in any orientation without the disturbance of formula flow.
Not only does Enteral feeding have an inverse effect on the life quality of children patients and their parents or caregivers but it has also shown to have a significant effect on their social and psychological behavior and sleeping patterns.[2-4] As a result, LLUMC is undergoing change by replacing Kangaroo Pet® with EnteraLite® for their Home Enteral nutrition patients. Since this transition is recent and current, comparing the effect of the old and new pumps on the quality of life will be feasible.
1.2 Statement of Problem
Old Enteral Feeding Administration equipment methodology is undesirable and out dated thereby negatively affecting the quality of life in children receiving HEN. Some pumps are inconvenient to use, require complicated administration techniques, and are difficult maintain. Loma Linda University Medical Center Patients are currently in the process of switching old pumps to improved technology. New Enteral feeding pumps are compact and easy to use.
We believe the current shift in technology may have a significant effect on the quality of life of children who rely on HEN for their nutrition. Thus, this study aims to investigate and compare the quality of life between these children, others who are still under the old Administration methods, and healthy age/gender matched healthy children.
1.3 Research Questions
This study was designed to answer the following research question:
To what extent does the new and old enteral nutrition administration technology impact the quality of life in children population receiving HEN therapy?
1.3.1 Research Hypotheses:
Replacement of old Enteral feeding technology with new equipment has a positive effect on the quality of life in children.
1.4 Delimitations
The study will be delimited to patients from Loma Linda University Medical Center. To be part of this study, participants have to be between the ages of 5 and 18 years old and must be on long-term (more than 6 months) HEN that requires feeding through pump administration. Bedridden patients were excluded, Children with neurological disease were excluded from the study since appropriate tools for measuring Quality of life are not available, Patients on Parenteral nutrition were excluded.
1.5 Limitations
1.5.1 Assumptions of the study:
It was assumed that participants were honest and unbiased in their response to the quality of life questionnaire. It was assumed that participants over 8 years old answered their own questionnaire; children less than 8 years old were assisted by their parents or caregivers. Parent proxy questionnaire were answered by the participant's parent.
1.6 Operational Definitions
Enteral Nutrition (EN) refers to a direct feeding route to the (GI) tract using a feeding tube in patients with NPO status.
Home Enteral Nutrition (HEN) refers to Enteral nutrition support in home environment.[5]
1.7 Other Definitions
Continuous Feeding:
Formula administrated at a constant, steady rate over 16-24 hour period.
Cyclic Feeding:
Formula administrated often over night, over 8-6 hours.
Intermittent Feeding:
formula volume is divided over several feedings per day, lasting 30-60 minutes each, every 4-6 hours.[6]
Bolus Feeding:
Formula administrated rapidly in less than 15 minutes, 4-6 times per day.
CHAPTER II
Literature Review
2.1 History:
Enteral nutrition has been around since ancient Egyptians used wine, milk, and grain broth enemas for health preservation and to provide direct absorption of nutrients through the circular system. [7]
As time went on, early elementary feeding devices were introduced to ease administration. English physician Reeve introduced enteral pumps in the 19th century, but since the use of enteral pumps was not common in health care, the next pump was not developed until 1950s physician Dr. James Barron. [8] It was not until the 1970s and '80s that hyperosmolar nutrient solution became more acceptable.[8] Since then, the field of nutrition support has undergone many changes, making large hoops in advancement just in the recent twenty years. This evolution of Enteral nutrition includes new development of feeding formulas, administering practices, improvement of advancement of pumps and delivery systems. Due to this new demand, companies started to produce a wide variety of enteral feeding pumps and what was once limited technology, began to mold into a sophisticated design [7]
2.2 Delivery Mechanism
2.2.1 Gravity:
A gravity drip bag used to be a common feeding technique. This method of delivery is common around the world where enteral pumps are not available. However, over the years, gravity bags are being replaced by convenient automatic pumps.
2.2.2 Rotary Peristaltic
A flexible part of a feeding tube is looped around the roller on the pump motor. As the motor turns it creates pressure pushing fluid through the tubing. Infusion rate depends on the speed of the motor. The pump is controlled by an individual controller for each device.[9] [7]
2.2.3 Cassette mechanism
Cassette mechanism is designed to prevent accidental free flow. A cassette is filled with formula and inserted into a cassette cavity. This measured amount of enteral product is pumped to ensure controlled and accurate infusion. [7]
2.3 Enteral Feeding Pumps
2.3.1 Kangaroo® petâ„¢ from Sherwood Medical
Uses a rotary peristaltic mechanism based pump. Infusion is 1 ml/hr up to 50 and 75 ml/hr with a 5 ml increase increment. [7] When battery is fully charged, the pump operates on battery power for 12 hours at a rate of 125mls/hour. Actual battery life depends on the rate of infusion. This pump can be stationary, plugged into the charger and attached to the I.V. pole. Another way is to unplug the pump from the charger thereby making the device portable. It is light enough (1.4 lbs or 635 g) where it can be worn as a back-pack or carried around the waist in a carrying case. The device has to be kept upright in order for formula to properly flow through the pump.[9]
2.3.2 EnteraLite® from Moog
Uses a rotary peristaltic pump and has no drip chamber in the administration set. This device can operate in any orientation without disturbance of formula flow. The battery is lithium ion and can operate 24 hours at 125 ml/hr rate. ENteraLite® weight less than one pound (14.4 oz or 408 g) and can be worn in custom carrying case. A 500 or 1200 ml formula filled bags or a spike set with prefilled containers can be placed inside the carrying case. It is by far the lightest ambulatory feeding pump on the market. The pump is recommended for pediatric infusion. [8, 10]
2.3.3 Kendall Kangaroo® Joeyâ„¢
Another non drip chamber portable device that provides continuous or intermittent feeding. This pump automatically recognizes the type of feeding set that is loaded, this feature is unique to Kangaroo® Joeyâ„¢. In addition, an automatic flush capability showed to reduce the tube replacement cost, reduction of nursing time, and reduction of manual flushes. [8] There is also a Bolus Max feature that allows a dose of up to 1000 ml Bolus Max that allows a dose of up to 1,000 mL at the rate 999 mL/hr to be delivered. With a weight being 1.7 lb (771.107 g), this device can also be transported in a portable case. With a fully charged battery, it can operate 18 hrs at 125 mL/hr feed rate.[11]
2.4 Outcomes
2.4.1 Sleep Disturbance
Sleep deprivation is frequently noticed with patients on home enteral nutrition.[12] Although feeding during the night gives an advantage to be "free" of infusion for day time activities, patients report disturbance from the pump alarm during the night hours. A large volume solution is being administered which causes an urgency to void frequently during the night. S.Evans et al. found the main cause for sleep disturbance to be due to obstruction of flow from children lying on the feeding pumps.[2].
2.4.2 Psychosocial
Some social difficulties are observed in pediatric HEN patients. Anxiety is developed when social and cultural situations are avoided. This avoidance also plays a significant role in socialization process for the child. Social acceptability of the child leads to depression and frustration. [13] With drip chamber pumps children cannot actively participate in recreational activity due to alarm sensors and interruption of formula flow. Alarm also could go off at any point during the day. This factor contributes to the child's anxiety and fear to be ridiculed by his or her peers.
CHAPTER III
Research Methodology
3.1 Study Participants:
3.1.1. Selection Criteria
A sample size will consist of 50% of children in HEN programs at Loma Linda University Medical Center in order to achieve 95% ± 5% confidence interval. Age ranging from 5 to 18 years old who are dependent on Home Enteral Feeding for longer than a 6 months and are using either old or new Enteral pumps.
3.1.2 Recruitment
Patients will be contacted by the Home Enteral Nutrition manager at Loma Linda University Medical Center to attain permission for confidential data access for research purposes. Once the consent is signed, a Generic core scale Quality of Life questionnaire (PedsQLâ„¢ Version 4.0) will be mailed to the participants and their parents via U.S. Mail. Once questionnaire is completed, a 25$ gift card will be mailed to participants.
3.2 Study Design
A cross sectional self-administrated survey study, where single time Quality of Life (â„¢ Version 4.0) will be administered to all participants and their parents (parent-proxy report).
3.3 Data Collection and Procedure
3.3.1 Measurement and Instrument:
PedsQLâ„¢ is a quality of life questionnaire of 24 questions which focuses on 4 health aspects:
However, the scores can be summarized into three categories:
This method divides age groups into 3 groups: 5 to 7 years old, 8 to 12 years old and 13 to 18 years old. Each child and parent gets a separate questionnaire regarding the child's health.[15] A separate sheet is included for the young children questionnaire with three faces (happy, content and sad) to make it easier for the child to answer the questions.
A five-point Likert scale (0=Never a problem, 1=Almost never problematic, 2=sometimes problematic, 3=often problematic, almost always problematic). Scores are computed on a scale from 0 to 100, (0=100, 1=75, 2=50, 3=25, 4=0) where 0 equals worst and 100 equals best or highest level of functioning. This survey is valid, reliable, and has internal consistency and has been shown to be affective even when done through phone interviews [16-22].
In addition, there will be questions regarding ease of administration and use of the current device. Furthermore, demographic questions such as name, gender, age, diagnosis, number of feeding days per week, number of feeding hours per 24 hours period, volume infused, route of feeding, type of pump used, how long current pump has been used, how often or how much food is consumed, and recent weight change.
3.4 Ethical Considerations
3.5 Protocols:
3.6 Data Management and Analysis:
Data will be analyzed using Statistical Package for the Social Sciences Software (SPSS). ANOVA test will be used to measure differences in the mean of quality of life between several Enteral nutrition administration devices. A p< 0.05 will be considered statistically significant. During this comparison, individual scale will be measured and evaluated against one another. Descriptive analysis will be used to analyze demographic data.
