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740 Asia Pac J Clin Nutr 2016;25(4):740-746

Original Article

Enteral nutrition preference in critical care:


fibre-enriched or fibre-free?

Hatice Yagmurdur MD, Figen Leblebici MD

Department of Anesthesiology and Intensive Care, Ankara Numune Education and Research Hospital,
Ankara, Turkey

Background and Objectives: This study’s main aim was to observe the effects of a fibre-enriched nutrition solu-
tion on requisite feeding volume, which is directly proportional to energy intake in mechanically ventilated pa-
tients with enteral nutrition. Methods and Study Design: Some 120 patients who required mechanical ventila-
tion and enteral nutrition with a nasogastric tube were studied. Upon ICU admission, the patient’s age, gender,
weight, height, comorbidities, diagnosis and APACHE II score were recorded. We assigned two diets to the pa-
tients randomly. The control group received the fibre-free nutrition solution. The study group, received the fibre-
enriched nutrition solution. Prescribed feeding volume and administered feeding volume, gastric residual volume
(GRV), volume ratio (VR), diarrhoea score and gastrointestinal complications (GIC) were recorded, along with
daily biochemistry. Results: The two groups did not differ with respect to age, sex, weight, BMI, APACHE II
score, target caloric intake or GRV (p>0.05). On days four and five, the study group had higher VR values
(p<0.05). Seventy-one (59%) patients had at least one gastrointestinal complication; 44 (73%) of them were con-
trols and 27 (45%) of them study patients. The most commonly observed GIC was diarrhoea. Thirty-eight pa-
tients had diarrhoea in control group, and twenty-two patients had diarrhoea in study group, and this difference
was statistically significant (p<0.001). There were no significant differences between the groups about vomiting
and regurgitation. Conclusions: We suggest that ICU staff initiate enteral nutrition with fibre-enriched formulas
rather than fibre-free formulas to avoid frequent feeding interruptions that cause protein energy malnutrition in
ICU patients.

Key Words: fibre-enriched nutrition, volume ratio, diarrhoea, enteral nutrition, gastric residual volume

INTRODUCTION mechanically ventilated patients with enteral nutrition.


Studies have shown that enteral nutrition is essential for Administering the necessary feeding volume depends on
the feeding of intensive care unit (ICU) patients with gastrointestinal system function; thus, the secondary goal
healthy gastrointestinal systems.1 Inefficient nutrition of this study was to investigate the incidence of gastroin-
volume administrations cause low daily caloric intake, testinal complications. Biochemical parameters were
which is correlated with destructive complications, such evaluated as a prediction of nutrition insufficiency.
as immunosuppression, increased risk of infections and
high mortality.2-5 Thus, uninterrupted, efficient nutrition METHODS
is crucial in ICU patients. However, conflicting infor- This study was conducted in a 25-bed adult medical ICU
mation exists in the literature regarding the preference of in an education and research hospital. The study was ap-
enteral feeding solutions. Research on osmolality, fat con- proved by the Institutional Review Board of the hospital.
tent, caloric intensity and fibre content of the formulas is Written informed consent was obtained from the patients’
ongoing, and a notable amount of studies have focused on next of kin before beginning the study.
fibre content. In regards to fibres that exist in nutrition This study included 120 participants who were between
solutions, oligofructose or fructo-oligosaccharide (FOS) 35-90 years of age and were of both genders. All patients
is a short-chain fructan that naturally exists in plants, and were chosen from individuals admitted to our ICU with
it is a soluble, highly fermentable, prebiotic fibre. Inulin
is another fructan that is soluble and fermentable and has
prebiotic effects. Acacia fibre, which has the same chem- Corresponding Author: Dr Hatice Yagmurdur, Ankara Nu-
mune Education and Research Hospital, Anesthesiology and
ical structure as arabic gum, is a soluble and fermentable
Intensive Care Department, Talatpasa Avenue N:5, 06110, Al-
fibre. Soy polysaccharide is an insoluble fermentable fi- tindag, Ankara, Turkey.
bre, and resistant starch and alpha cellulose are insoluble Tel: 05056527365; Fax: +90312 311 43 40
and non-fermentable fibres. Email: hyagmurdur@yahoo.com
The main aim of this study was to observe the effects Manuscript received 14 March 2015. Initial review completed
of a fibre-enriched nutrition solution on requisite feeding 18 June 2015. Revision accepted 14 July 2015.
volume, which is directly proportional to caloric intake in doi: 10.6133/apjcn.122015.12
Fibre-enriched nutrition in ICU 741

acute cerebrovascular disease (e.g. ischemia, haemor- the previous rate. Tolerance to nutrition was assessed
rhage) who required mechanical ventilation and enteral daily as the GRV. During the first day of enteral nutrition,
nutrition with a nasogastric tube. Upon ICU admission, GRV was measured every 6 h. On the second day, GRV
the patient’s age, gender, weight, height, comorbidities, was measured every 8 h, and for the patients who tolerat-
diagnosis and APACHE II (Acute Physiology and Chron- ed the enteral nutrition well, GRV was measured once a
ic Health Evaluation) score were recorded. Patients who day after the third day. GRV was measured by connecting
were fed within 48 h after ICU admission were included a drainage bag to the nasogastric tube and waiting 15
in the study. The exclusion criteria were the following: mins for gravity drainage. The patients were considered
unstable haemodynamic values, sepsis, contraindications to have tolerated the enteral nutrition well when the GRV
for enteral feeding (gastrointestinal tract obstruction, was <500 mL daily, and those who consumed at least 750
haemorrhage and ileus), pancreatitis, gastrointestinal dis- mL of enteral nutrition with <500 mL GRV a day, were
eases (ulcerative colitis, Chron’s disease and ischaemic or included in the study protocol.
infectious colitis), obese patients (body mass index (BMI) The efficiency of the enteral nutrition was measured
>35 kg/m2), malnutrition syndromes, immunosuppressed daily by volume ratio (%).
patients and severe biochemical results on admission day. VR (%) = (administered volume of nutrition / prescribe
Additionally, patients who were given broad-spectrum volume of nutrition) x 100.
antibiotics for a severe infection, whether gastrointestinal During the study, prescribed feeding volume and ad-
or not, were excluded from study. ministered feeding volume, GRV, RV, diarrhoea scores
After ICU admission, a nasogastric tube (12 or 14 Fr, and gastrointestinal complications (GIC) (distension,
Compat Soft Y; Nestle Nutrition; Germany) was inserted vomiting, regurgitation and constipation) were recorded.
in all patients who were mechanically ventilated and The definitions and managements of the gastrointestinal
could not be fed orally. Every day, the positioning of the complications were as follows:
tube was checked radiologically. All patients were man- 1. Abdominal distention was defined as the presence of
aged in the semi-recumbent position (30-45°) to decrease excessive amounts of gases in the stomach or intestine.
pneumonia incidence. Mechanical ventilation settings It was diagnosed with tympany or the absence of bow-
were adjusted according to the patients’ artery blood gas el sounds during physical examination. After ruling out
results. intraabdominal pathologies, nutrition was decreased to
Sealed, numbered envelopes were used for randomiza- half the normal rate when distention was detected. In
tion. The medical staff who performed the GI measure- the following 12 h, if the distension disappeared, nutri-
ments and assessed GI complications were blind to the tion was increased to the original rate, and if it persist-
study. We assigned two diets to the patients randomly. ed, nutrition was ruled out as its cause.
The control group, Group FF, received the fibre free nu- 2. Regurgitation was defined as the observation of enteral
trition solution Nutrison (500 mL, Nutricia Advanced formula in the oral cavity. If regurgitation was detect-
Medical Nutrition; Netherlands). The study group, Group ed, intraabdominal pathologies were searched for by
FE, received the fibre-enriched nutrition solution Nu- radiological examination. If a pathology was found,
trison multifibre (500 mL, Nutricia Advanced Medical such as ileus or tract obstruction, nutrition was with-
Nutrition; Netherlands). The characteristics of 500 mL of drawn, and if GI functioning was normal, nutrition was
Nutrison/Nutrison multifibre are as follows: energy 500 continued.
kcal/515 kcal, protein 20 g/20 g, carbohydrate 61.5 g/61.5 3. Vomiting was defined as ejection of the enteral formu-
g, fat 19.5/19.5 g and osmolarity 255 mOsmL-1/300 la through the mouth. The management of the vomiting
mOsmL-1. Nutrison multifibre contains both soluble and was same as that for regurgitation.
insoluble fibres in approximately a 1:1 ratio, 0.7 g and 0.8 4. Constipation was defined as the absence of defecation
g per 100 mL, respectively. The content of the six fibres for more than three days. If constipation was observed,
in the solution are 32% soy polysaccharides, 24% arabic the nutrition infusion route was not changed, but a lax-
gum, 12.5% inulin, 12% alpha-cellulose, 10.5% oli- ative or enema was administered.
gofructose and 9% resistant starch. All patients were giv- 5. Diarrhoea was assessed according to a score defined
en the nutrition solution using an enteral feeding pump by Hart and Dobb6 (Table 1). Each stool of the patient
(Kangaroo Enteral Feeding Pump; Covidien; USA). None was scored according to its estimated volume and con-
of the patients received any broad-spectrum antibiotics or sistency. The sum of the scores in 24 h was the diar-
antidiarrhoeal or laxative agents such as lactulose, sorbi- rhoea score of the patient. Diarrhoea was defined as a
tol or glycerin suppositories. Metoclopramide was admin- daily score ≥12. If liquid stools were observed more
istered twice a day to all patients as a prokinetic agent. than five times a day or the total estimated volume of
Energy administration was aimed at 25-35 kcal/kg/day the stools was ≥2,000 mL/day, the patient was exam-
and was given from 18-24 h every day at a constant rate.
On the first day, 50% of the required energy intake was
Table 1. Diarrhoea score as proposed by Hart and
administered, followed by 75% on the second day and Dobb6
100% on the third day. Enteral nutrition was started at a
rate of 20 mL/h and increased at six hour intervals to 40 Estimated volume (mL)
Consistency
mL/h, 80 mL/h, 100 mL/h and, if needed, to 120 mL/h. If <200 200-250 >250
the patient did not tolerate the nutrition feeds according to Formed 1 2 3
the gastric residual volume (GRV) values mentioned be- Semi-solid 3 6 9
low at any time of the day, nutrition rate was decreased to Liquid 5 10 15
742 H Yagmurdur and F Leblebici

Table 2. Patient characteristics

Fibre-free group (n=60) Fibre-enriched group (n=60)


Age (yr) (mean±SD) 70±15 71±14
Gender (m/f) (n) 26/34 24/36
Weight (kg) (mean±SD) 76.7±9.8 76±10.6
BMI (kg/m2) (mean±SD) 27.2±3.7 27±4.5
APACHE II Score (mean±SD) 15.7±2.6 15.7±2.9
Target energy intake(kcal/kg/day) (mean±SD) 2272±273 2282±295

ined for GI problems. If a problem was detected, nutri- Table 3.Gastrointestinal tolerance over five days
tion was withdrawn. If no problem was detected, the
nutrition infusion rate was decreased to half of the Daily GRV Fibre-free group Fibre-enriched
p value
(mean±SD) (n=60) group (n=60)
normal rate, and the patient was observed for diar-
Day 1 138±100 113±96 0.205
rhoea for 8 h. After 8 h, if the diarrhoea decreased, nu- Day 2 136±115 127±116 0.748
trition infusion was returned to the original rate. If the Day 3 114±91 126±98 0.764
severity of the diarrhoea persisted, the nutrition prod- Day 4 117±114 129±100 0.819
uct was changed, and the patient was withdrawn from Day 5 97±72 122±93 0.240
the study.
The patients were considered as tolerant of the enteral Table 4. Daily volume ratio (%) (mean±SD) accord-
nutrition well if the nutrition feeds did not need any inter- ing to groups and gastrointestinal complications (GIC)
ruption as a consequence of the complications defined
above. Fibre-free group Fibre-enriched
p value
As an important complication, pulmonary aspiration (n=60) group (n=60)
was also taken into account. It was diagnosed when en- Day 1 78.5±12.3 75.9±11.0 0.108
Day 2 81.4±11.9 83.4±11.2 0.310
teral formula was found in the tracheal aspirate. Pulmo-
Day 3 82.0±13.6 85.9±11.9 0.096
nary aspirated patients were excluded from the study and Day 4 81.0±13.5 86.4±12.6 0.021
managed according to a special aspiration pneumonia Day 5 80.8±14.3 89.4±12.4 0.000
treatment protocol. Mean 80.8±9.6 84.2±9.8 0.035
Daily biochemical parameters (haemoglobulin, total
protein, albumin, prealbumin, total cholesterol, calcium, Table 5. Daily volume ratio (%) (mean±SD) accord-
phosphate, magnesium, sodium, potassium, glucose, urea, ing to gastrointestinal complications (GIC)
creatinine, alanine aminotransferase and aspartate amino
transferase) were recorded. The statistical package SPSS Patients with Patients without
p value
20.0 for Windows (SPSS Inc, Chicago, IL) was used for GIC (n=71) GIC (n=49)
the statistical analysis. All values are expressed as the Day 1 72.8±12.2 83.6±7.3 <0.0001
means ± standard deviation. Qualitative data were ana- Day 2 76.5±10.9 90.9±5.8 <0.0001
Day 3 78.1±13.0 92.3±6.4 <0.0001
lysed by the chi-square test. Quantitative data were ana- Day 4 76.7±12.6 93.9±4.9 <0.0001
lysed by analysis of variance or the Mann-Whitney U- Day 5 77.5±13.2 96.2±4.3 <0.0001
test. The haemodynamic parameters obtained at various Mean 76.3±7.6 91.4±4.1 <0.0001
time intervals within the same group were compared with
the baseline values using the paired t-test. As both param- higher VR values, and this difference was statistically
eters were normally distributed, the correlation coeffi- significant (p<0.05) (Table 4, 5). The data analysis of all
cients and their significance were calculated using the patients collectively showed that VR was higher in the
Pearson test. A p-value of ≤0.05 was deemed significant. patients lacking GICs (p<0.001), and this relationship was
consistent throughout the entire study. Seventy-one (59%)
RESULTS patients had at least one gastrointestinal complication; 44
A total of 120 patients were studied. After the initiation of (73%) of them were in Group FF, and 27 (45%) of them
the study, none of the patients were excluded from the were in Group FE. This difference was statistically signif-
study for the indications outlined in the methods section. icant and was the second main result of the study
The two groups did not differ with respect to age, sex, (p<0.01). The most commonly observed gastrointestinal
weight, BMI, APACHE II score or target caloric intake complication in this study was diarrhoea. Sixty patients
(Table 2). (50%) had diarrhoea for at least one day of the study; 38
There was no difference between the groups in the dai- of them were in Group FF, and 22 of them were in Group
ly GRV measurements (Table 3). Only four patients’ FE, and this difference was statistically significant
GRV values exceeded 500 mL for one day; three of those (p<0.001). The daily diarrhoea score was used to obtain
patients were in Group FF, and one was in Group FE. more information about the diarrhoea. In the first two
The main goal of this study was to assess the efficiency days, there was not a significant difference in the daily
of the nutrition solutions. This was established with daily diarrhoea score between the groups. However, in last
VR measurements. In the first three days of the study, three days, Group FF had higher diarrhoea scores, and
there was no difference in the VR values between the this difference was statistically significant (p<0.01). The
groups. However, on days four and five, Group FE had mean diarrhoea scores over the five days of the study in
Fibre-enriched nutrition in ICU 743

Table 6. Gastrointestinal complications over five days

Fibre-free group (n=60) Fibre-enriched group (n=60) p value


Daily diarrhoea score (mean±SD)
Day 1 8.5±6.9 7.1±7.1 0.055
Day 2 8.7±7.5 7.1±5.6 0.147
Day 3 10.2±8.0 7.6±6.1 0.009
Day 4 11.7±7.8 8.6±6.6 0.008
Day 5 12.0±8.4 7.3±5.9 <0.0001
Diarrhoea score for five days (mean±SD) 10.2±5.4 7.5±4.7 <0.0001
Patients at least 1 day with diarrhoea (n) 38 22 0.006
Regurgitation (n) 9 10 1.0
Vomiting (n) 10 9 1.0
Distension (n) 18 25 0.253
Constipation 2 2 1.0

Group FF and Group FE were 10.2±5.4 and 7.5±4.7, re- tinal tract tolerance. When this was not the case, during
spectively, and this difference was statistically significant the first days of enteral nutrition, we measured GRV fre-
(p<0.001). Severe diarrhoea, as defined above, was not quently (three or four times a day). Additionally, the rou-
observed in any patients. There were no significant dif- tine metoclopramide administration in our study may
ferences between the groups for the other gastrointestinal have been another factor that caused the low gastric re-
complications (vomiting, regurgitation, distention and sidual volumes that we observed.
constipation) (Table 6). Nine patients (15%) in Group FF Chang et al8 reported that drugs (e.g. antibiotics), infec-
and ten patients (16%) in Group FE had regurgitation. tions, illness severity and enteral feedings are the causes
Ten patients (16%) in Group FF and nine patients (15%) of diarrhoea in the ICU. Whelan et al9 reported that the
in Group FE vomited. 18 patients (30%) in Group FF and frequency of diarrhoea in enteral-fed patients ranged from
25 patients (42%) in Group FE had abdominal distention. 2 to 95% and that this large variation was due to different
Two patients (3%) in each group were constipated, and definitions of diarrhoea and different measurement meth-
all of them were treated successfully with an enema or ods. In the present study, the most frequent complication
laxatives. Other complications were not severe and were was diarrhoea, and it occurred in 50% of patients. Enteral
managed with the protocols described above. The bio- nutrition is a contributing factor to ICU diarrhoea because
chemical parameters on day one and day five were com- it alters gut physiology. Whelan et al10 hypothesized that
pared. There were no statistically significant differences enteral feeding changes both transit time, secretory mech-
in any of the biochemical parameters between the groups. anisms and the microbiota in the gastrointestinal tract.
Luft et al11 showed the importance of enteral feeding so-
DISCUSSION lution and feeding equipment sterility by decreasing the
The patients studied were admitted to the ICU with acute frequency of diarrhoea using hygiene protocols. The
cerebrovascular disease. We excluded patients with intes- properties of nutrition solutions that have been examined
tinal pathologies and infectious diseases, such as sepsis, for their diarrhoeal effects are temperature, osmolality, fat
as these comorbidities and the therapies used to treat them content and caloric density, but strict guidelines for these
could affect intestinal function. The main outcome of the properties of nutrition solutions have not been made.12
study was that of preferred nutrition feed for gastrointes- One of the most controversial components of feeding
tinal function. We showed that fibre-free nutrition gener- solutions is fibre. Dietary fibre has been shown to have
ated higher gastrointestinal complications, especially di- various effects by multiple studies. Krusawa et al13 and
arrhoea, than fibre-enriched nutrition. To demonstrate the Cummings JH14 showed that dietary fibre increases stool
consequences of the gastrointestinal complications like weight allowing for easier defecation. Salmeron et al15
diarrhoea, volume ratio was used; it provided a measure reported glucose regulating effects of dietary fibre. Fibres
of feed efficiency. The main result of this study was that that promote beneficial bacterial growth, such as that of
fibre-enriched nutrition resulted in less gastrointestinal lactobacillus and bifidobacteria, are called prebiotics.
complications and higher VR values, which was predic- Prebiotics improve gut barrier function and host immuni-
tive of more effective patient nutrition. ty and reduce the overgrowth of pathogenic bacteria, such
Montejo et al7 found that the most frequent complica- as clostridia.16 Inulin and FOS are the main prebiotics in
tion in enteral nutrition was high gastric residual volume. our study solution. As examples of the immunological
This is different from the results of our study and may be support provided by prebiotics, it has been shown that
due to the use of a different nutrition solution or different FOS consumption increases T-lymphocytes in adults,
GRV measurement methods. At present, a clear consen- increases antibody response to vaccines in infants and
sus regarding the measurement method and the limits of reduces antibiotic consumption.17-19 Elia et al20 reported a
gastric residual volume has not been reached. In our clin- systemic review and meta-analysis that proved that fibre-
ical practice, enteral nutrition is started at a rate of 20 enriched feeding formulas reduce diarrhoea incidence.
mL/h and is increased gradually. If, the gradual increment Chittawatanarat et al21 showed that mixed fibre formulas,
is not interrupted on account of intolerance and the pa- like our formula, in particular, can reduce diarrhoea in
tient receives the prescribed feed volume, daily GRV septic ICU patients receiving broad spectrum antibiotics.
measurement is sufficient to anticipate upper gastrointes- Soluble fibres (e.g. pectin, FOS, inulin, guar gum) have
744 H Yagmurdur and F Leblebici

antidiarrhoeal mechanisms. Namely, after soluble fibre malnutrition in ICU patients.


fermentation by colonic anaerobic bacteria, short-chain
fatty acids (SCFAs) are produced. SCFAs are beneficial AUTHOR DISCLOSURES
for colonocytes and stimulate water uptake.21,22 Majid et None.
al23 reported that fibres reduced diarrhoea incidence and
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241-6. doi: 10.1079/BJN/2002543. tensive Care Med. 1990;16:252-5. doi: 10.1007/BF0170516
20. Elia M, Engfer MB, Green CJ, Silk DBA. Systemic review 1.
and meta-analysis: the clinical and physiological effects of 26. Jack L, Coyer F, Courtney M, Venkatesh B. Probiotics and
fibre-containing enteral formulae. Aliment Pharmacol Ther. diarrhoea management in enterally tube fed critically ill pa-
2008;27:120-45. doi: 10.1111/j.1365-2036.2007.03544.x. tients-what is the evidence? Intensive Crit Care Nurs. 2010;
21. Chittawatanarat K, Pokawinpudisnun P, Polbhakdee Y. 26:314-26. doi: 10.1016/j.iccn.2010.07.001.
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Clin Nutr. 2010;19:458-64. management practices in relation to diarrhea during enteral
22. Schneider SM. Microbiota and enteral nutrition. Gastroen- nutrition. Nutr Clin Pract. 2012;27:252-6. doi: 10.1177/0884
terol Clin Biol. 2010;34:57-61. doi: 10.1016/S0399-8320 533611431986.
746 H Yagmurdur and F Leblebici

Original Article

Enteral nutrition preference in critical care:


fibre-enriched or fibre-free?

Hatice Yagmurdur MD, Figen Leblebici MD

Department of Anesthesiology and Intensive Care, Ankara Numune Education and Research Hospital,
Ankara, Turkey

重症监护中的肠内营养选择:富含还是不含膳食纤维?

背景与目的:本研究的主要目的是观察一个富含纤维营养液对必要给与量的
影响,这与机械通气的肠内营养患者能量摄入成正比。研究设计与方法:对
需要机械通气和肠内营养鼻饲管的 120 例患者进行了研究。在进入 ICU 前,
记录患者的年龄、性别、体重、身高、疾病、诊断和 APACHE II 评分。我们
随机将患者分至两种饮食。对照组给予无膳食纤维营养液。研究组给与富含
膳食纤维营养液。在每日生化检测时,记录处方量和实际给予量、胃残留量
(GRV)、体积比(VR)、腹泻评分和胃肠道并发症(GIC)。结果:两组
患者的年龄、性别、体重、BMI、APACHEⅡ评分、热量摄入或 GRV 均无统
计学意义(p>0.05)。在第 4 和 5 天时,研究组的 VR(p<0.05)较高。71
(59%)例患者至少有 1 种胃肠道并发症,其中对照组 44 例(73%),研究
组 27 例(45%)。腹泻是最常见的 GIC。对照组 38 例、研究组 22 例患者有
腹泻(p<0.001)。两组间呕吐和反流的发生率无统计学意义。结论:我们建
议,对 ICU 患者启动肠内营养与富含膳食纤维的配方,而不是无膳食纤维配
方,以避免频繁喂养中断导致蛋白质-能量营养不良。

关键词:富含纤维营养、体积比、腹泻、肠内营养、胃残留量
CHECKLIST CONSORT PADA PENELITIAN EKSPERIMEN

Enteral Nutrition Preference in Critical Care :

Fibre-Enriched or Fibre-Free ?

Topik Nomor Checklist Dilaporkan


pada halaman
Title and 1a Pada judul penelitian, tidak menyebutkan sebagai 740
Abstrack penelitian randomized trial . Judul dituliskan dalam
bentuk kata tanya, yaitu Enteral Nutrition Preference in
Critical Care : Fibre-Encriched or Fibre-Free?
Fibre-Free ?

1b Pada abstrak, sudah menuliskan ringkasan dari 740


penelitian yang dilakukan secara terstruktur yaitu latar
belakang, metode dan desain penelitian, hasil penelitian
dan kesimpulan, serta kata kunci dari penelitian
tersebut.

Introduction 2a Latar belakang masalah sudah dijelaskan secara ilmiah 740


Background dan rasional berdasarkan sumber penelitian sebelumnya
And Objectives yang diambil dari American Journal Clinical Nutrition,
Intensive Care Medicine,
Medicine, dll. Namun pada paragraph
pertama Pendahuluan, kalimat ketiga dan seterusnya
tidak dituliskan sumber pustaka/referensi penulisannya.

2b Peneliti sudah menuliskan tujuan penelitian dalam 740


paragraf kedua pada bab Pendahuluan
Pendahuluan meliputi tujuan
utama dan tujuan sekunder, dimana tujuan utamanya
adalah untuk mengetahui efek dari pemberian nutrisi
yang diperkaya serat sesuai dengan asupan kalori yang
dibutuhkan pada pasien yang menggunakan ventilator
dengan nutrisi enteral. Sedangkan tujuan sekundernya
adalah untuk meneliti insiden komplikasi
gastrointestinal.
Hipotesis penelitian tidak dituliskan dalam bab
Pendahuluan.

Methods
Trial design 3a Desain penelitian tidak disebutkan secara jelas. Dalam 740-741
bab Metode penelitian disebutkan pasien ICU yang yang
sesuai dengan kriteria inklusi diberikan 2 jenis
intevensi diet secara acak pada 2 kelompok yaitu
kelompok kontrol (kelompok Fiber-Free) dan
kelompok penelitian (kelompok Fiber-Enriched).
Randomization/ pengacakan dilakukan secara tertutup.
Rasio alokasi atau distribusi kelompok tidak dijelaskan
secara rinci.

Sudah dijelaskan alasan dari penentuan kriteria


3b kelayakan pada subyek penelitian, yaitu selama 741-742
penelitian berjalan, komplikasi gastrointestinal diamati.
Jika terdapat distensi, vomitus, regurgitasi, konstipasi
dan diare seperti yang didefinisikan di Bab Metode
halaman 741, subyek dapat dikeluarkan dari penelitian
atau dapat juga dilanjutkan intervensinya sesuai dengan
hasil pemeriksaan lanjutan.

Sudah dijelaskan mengenai kriteria sebagai subyek


Participant 4a penelitian meliputi kriteria inklusi dan ekslusi. Kriteria 741
inklusi pada penelitian ini meliputi pasien yang dirawat
di ruang ICU, usia 35-90 tahun, pasien dengan penyakit
cerebrovaskuler akut yang membutuhkan ventilator dan
nutrisi enteral dengan NGT, serta pasien yang
memperoleh feeding dalam 48 jam setelah pengkajian
ICU (usia, jenis kelamin, berat badan, tinggi badan,
komorbiditas, diagnosis dan skor APACHE II).
Sedangkan kriteria eksklusinya adalah pasien dengan
kondisi hemodinamik yang tidak stabil, sepsis,
kontraindikasi pada nutrisi enteral (obstruksi saluran
GI), hemoragik, dan ileus), pancreatitis, penyakit GI
(ulcerative colitis, Chron’s disease, dan iskemik atau
infeksi colitis), pasien obes (BMI > 35 kg.m 2), sindrom
malnutrisi, pasien imunosupresi, dan hasil biokimia
yang sangat parah serta memperoleh antibiotik
spektrum luas.

4b Tidak disebutkan secara jelas lokasi penelitian, dalam 740


Bab Metode paragraf pertama hanya disebutkan
penelitian dilakukan di ruang ICU di sebuah Rumah
sakit pendidikan dan penelitian. Namun dalam artikel
ini, juga dicantumkan alamat korespondensi peneliti
yaitu di Ankara Numune Education and Research
Hospital, Anesthesiology and Intensive Care
Department, Turki.

Interventions 5 Intervensi yang diberikan pada subyek penelitian sudah 741


dijelaskan secara urut dan rinci serta bagaimana dan
kapan pengambilan datanya, yang dijelaskan di Bab
Metode. Dimana intervensi yang diberikan pada subyek
penelitian adalah sebagai berikut :
1. Semua Pasien ICU yang sudah melalui pengkajian
dan menggunakan ventilator serta tidak dapat
makan/minum per oral, dipasangkan NGT. Setiap
hari dilakukan pengecekan degan radiologi terkait
posisi NGT. Semua pasien diatur dalam posisi semi
telentang (30-45°) untuk mengurangi kejadian
pneumonia. Ventilator diatur sesuai hasil Analisa
gas darah arteri pasien.
2. Secara acak dan tertutup dilakukan pembagian
kelompok menjadi 2 dengan pemberian 2 jenis diet.
3. Kelompok kontrol (FF) menerima Nutrison, solusi
nutrisi bebas serat. Kelompok penelitian (FE)
menerima Nutrison multifiber, solusi nutrisi yang
diperkaya serat. Pemberian nutrisi menggunakan
enteral feeding pump.
4. Pada hari pertama, asupan enteral diatur untuk
memenuhi 50% kebutuhan energi, diikuti hari
kedua 75% dan 100% di hari ketiga.nutrisi enteral
dimulai dari 20 ml/jam dan meningkat pada interval
6 jam menjadi 40 ml/jam, 80 ml/jam, 100 ml/jam
dan jika perlu sampai 120 ml/jam.

Outcomes 6a Sudah dijelaskan secara spesifik mengenai sumber data 741-742


dan cara pengambilan data baik data primer maupun
sekunder serta waktu pengambilan datanya,
diantaranya:
1. Pengukuran GRV (Gastric Residual Volume) untuk
mengetahui toleransi dari pemberian nutrisi enteral.
Pengukuran GRV pada hari pertama dilakukan
setiap 6 jam, pada hari kedua setiap 8 jam dan pada
pasien yang toleransi terhadap nutrisi enteralnya
baik, pengukuran GRV dilakukan 1x sehari setelah
3 hari.
2. Pengukuran erhadap VR (Volume Ratio (%))
dilakukan setiap hari untuk mengetahui efisiensi
nutrisi enteral.
3. Pengukuran skor diare dan komplikasi pada saluran
cerna seperti distensi, vomitus, regurgitasi dan
konstipasi.
4. Data komplikasi pulmonary aspiration berdasarkan
diagnosa dokter ketika formula enteral ditemukan
pada bunyi aspirasi trachea.
5. Parameter biokimia (hemoglobin, total protein,
albumin, prealbumin, total cholesterol, calcium,
phosphate, magnesium, sodium, potassium,
glucose, urea, creatinine, alanine aminotransferase)
dicatat setiap hari.

6b Tidak menyebutkan ada perubahan protokol penelitian -


selama penelitian berjalan.

Sample size 7a Penentuan besar sampel tidak disebutkan secara jelas. 740
Dalam Bab Metode hanya disebutkan besar sampel
sejumlah 120 pasien ICU yang dirawat, yang
memenuhi kriteria inklusi penelitian, dimana informed
consent diperoleh dari keluarga terdekat pasien sebelum
dilakukan intervensi.

7b Dalam artikel penelitian Bab Metode sudah dijelaskan 742


tentang pedoman penghentian sampel atau
dikeluarkannya sampel sebagai subyek penelitian, yaitu
jika pasien mengalami diare persisten (lebih dari 8 hari)
yang mengindikasikan adanya masalah GI, pasien
dikeluarkan dari subyek penelitian. Namun pada
aplikasinya, peneliti melaporkan di Bab Hasil bahwa
dari 120 pasien, tidak ada yang diekslusi dari
penelitian.

Randomisation:
Sequence 8a Metode random untuk menentukan alokasi sudah 741
generation dijelaskan yaitu secara tertutup, penomoran
dimasukkan dalam amplop tertutup. Staf medis yang
melakukan pengukuran GI dan mengkaji komplikasi GI
tidak mengetahuinya (blind).
8b Tipe randomisasi tidak dijelaskan secar rinci, dalam 741
bab Metode hanya menyebutkan bahwa random
dilakukan dengan penomoran dalam amplop tertutup.
Allocation
concealment 9 Mekanisme yang digunakan untuk implementasi 741
mechanism random untuk urutan alokasi hanya dijelaskan secara
singkat yaitu secara tertutup. Peneliti memberikan 2
diet pada subyek secara acak, sehingga terbagi menjadi
2 kelompok yaitu kelompok penelitian dan kelompok
kontrol.

Implementation 10 Dalam Bab Metode, dijelaskan yang melakukan 741


random untuk menentukan alokasi adalah peneliti
sendiri.

Blinding 11a Dalam bab Metode disebutkan bahwa setelah intervensi 741
diet yang diberikan pada subyek penelitian yang sudah
dibagi menjadi 2 kelompok secara acak dan tertutup,
staf medis yang melakukan pengambilan data, tidak
mengetahui tentang alokasinya.

11b Pemberian intervensi pada masing-masing kelompok 741


sudah disebutkan secara rinci dan mendeskripsikan
kesamaan/kemiripan dari intervensi yaitu pemberian
nutrisi enteral, kelompok kontrol berupa nutrisi enteral
bebas serat dan kelompok penelitian berupa nutrisi
enteral yang diperkaya serat.

Metode statistik 12a Sudah menyebutkan metode statistik yang digunakan 742
untuk analisis data primer dan sekunder yaitu uji chi
square untuk analisis data kualitatif, analisis varian
dengan uji Mann-Whitney untuk data kuantitatif..

12b Dalam bab Metode paragraph akhir disebutkan 742


dilakukan analisis untuk parameter hemodinamik
diperoleh dari interval waktu dalam kelompok yang
sama dibandingkan dengan nilai awal intervensi
menggunakan uji Paired t-test. Jika kedua parameter
dalam distribusi normal, koefisien korelasi dan
signifikansinya dihitung menggunakan Pearson test.

Results
Participant 13a Dalam artikel ini, tidak mencantumkan flow diagram 742
flow penelitian. Dalam Bab Hasil, disebutkan total subyek
penelitian adalah 120 pasien, yang dibagi menjadi 2
kelompok yaitu kelompok kontrol (n=60) dan
kelompok penelitian (n=60).

13b Pada Bab Hasil paragraf pertama, peneliti menyebutkan 742


tidak ada pasien yang dieksklusi dari penelitian untuk
indikasi yang sudah dijelaskan di Bab Metode.

Recruitment 14a Tidak disebutkan secara jelas tanggal/waktu penelitian, 742


hanya menjelaskan tentang periode pengambilan data
penelitian pada Bab Hasil selama 5 hari pengamatan.

14b Tidak disebutkan alasan penelitian dihentikan, karena -


penelitian diakhiri setelah semua proses intervensi dan
pengambilan data selesai.

Baseline data 15 Sudah menampilkan tabel tentang karakteristik 742


demografi dan klinis data serta hasil penelitian pada
tiap kelompok seperti karkteristik umur, jenis kelamin,
berat badan, BMI, skor APACHE II dan target asupan
energi yang diperesentasikan dalam mean ± SD.

Number 16 Pada Bab Hasil, sudah disebutkan jumlah data yang 742-743
analysed dianalisis, yaitu 60 pasien tiap kelompok karena tidak
ada data yang missing. Pada pelaksanaan penelitian,
komplikasi GI yang dialami pasien masih dapat
tertangani sesuai dengan protokol penelitian yang sudah
dijelaskan di Bab Metode, sehingga data yang diperoleh
dapat dianalisis.

Outcomes and 17a Sudah menjelaskan presisi untuk tiap data penelitian 742
estimation dari masing-masing kelompok yaitu signifikan pada
nilai p < 0,05 (95% Confidence Interval)

17b Pada penelitian ini tidak mempresentasikan besaran -


efek absolut dan efek relatif

Ancillary 18 Analisis data baik untuk data kualitatif maupun data 743
analyses kuantitatif sudah dilakukan, ditampilkan pada tabel 3,
4, 5 dan 6. Selain itu juga dilakukan analisis untuk
parameter biokimia dengan membandingkan hasil di
hari 1 dan hari 5, namun hasil analisis tidak ditampilkan
dalam tabel, peneliti hanya menyebutkan tidak ada
perbedaan yang signifikan secara statistik pada
parameter biokimia antar kelompok.

Harms 19 Pada penelitian ini sudah menyebutkan antisipasi resiko 741


negatif yang mungkin muncul akibat dari treatmen
yang diberikan (nutrisi enteral) berupa gangguan
saluran cerna (gastrointestinal complication) yaitu
dengan protokol medis yang sudah dijelaskan pada bab
Metode.

Discussion
Limitation 20 Pada bab Pembahasan, peneliti tidak menyebutkan 744
secara jelas keterbatasan penelitian. Hanya pada
beberapa indikator data yang menunjukkan tidak
adanya perbedaan yang signifikan yaitu pada
pengukuran biokimia, peneliti menyebutkan hal ini
dikarenakan perbedaan serat yang digunakan dan
ukuran sampel yang kecil.

Generalizability 21 Penelitian ini menyebutkan generalisasi dari hasil 743-744


penelitiannya bahwa pada pasien ICU dianjurkan untuk
pemberian nutrisi enteral yang diperkaya serat
dibandingkan yang bebas serat, dengan didukung dari
hasil penelitian lain yang sejenis.

Interpretation 22 Pada Bab Pembahasan, sudah menampilkan interpretasi 743-744


hasil penelitian dengan mempertimbangkan tujuan
penelitian dan bukti yang relevan berupa hasil Analisa
statistik, selain itu sudah mengkaitkan dengan hasil-
hasil dari penelitian sebelumnya.

Other
information 23 Tidak mencantumkan nomor dan nama registrasi -
Registration percobaan

Protocol 24 Tidak menyebutkan alamat dimana dapat memperoleh -


protokol penelitian secara penuh.

Funding 25 Tidak menyebutkan sumber dana penelitian -

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