CI: Gastric vs. Small Bowel Feeding (2011)
Hsu CW, Sun SF, Lin SL, Kang SP, Chu KA, Lin CH, Huang HH. Duodenal vs. gastric feeding in medical intensive care unit patients: A prospective, randomized, clinical study. Crit Care Med. 2009 Jun; 37(6): 1,866-1,872.PubMed ID: 19384225
To determine if MICU patients with nasoduodenal feedings have better outcomes than patients who have nasogastric feedings.
- Patient in MICU eligible to receive EN (no intractible vomiting, severe diarrhea or paralytic ileus)
- Expected to need feeding tube for three days or more.
- Not expected to need EN for three days or more
- Intractable vomiting
- Severe diarrhea
- Paralytic ileus
- Abdominal surgery
- Acute pancreatitis
- GI bleeding
- Intestinal obstruction
- Short bowel syndrome
- Chronic renal disease with creatinine 2.5mg per dL or more
- Hepatic disease with encephalopathy requiring protein restriction.
All eligible patients admitted to MICU from January 2005 to December 2006 that gave informed consent (patient or relative).
Randomized controlled trial; randomization per computer (software was Experimental Design Generator and Randomizer).
Caregivers (nurses) blinded to randomization sequence.
EN tube placement in stomach vs. duodenum.
- Intent-to-treat data analyses
- Student's T-test to compare continuous variables with normal distribution
- Mann-Whitney U-test to compare continuous variables with non-normal distribution
- Chi-square or Fisher's exact test to compare dichotomous variables
- All P-values two-tailed with P<0.05 considered significant.
Timing of Measurements
- Residuals checked every four hours (increased to every two hours if aspirated volume was more than 100ml)
- Daily recording of calorie and protein intake
- Daily recording of medications including prokinetic agents
- Blood glucose monitored by intensive insulin control protocol to maintain level between 120 and 140mg per dL
- Daily monitoring for:
- Vomiting (food found in pharynx or mouth)
- Diarrhea (three or more bowel movements or more than 200ml liquid stool without use of laxatives or high osmolarity medications via feeding tube in 24 hours)
- GI bleeding (presence of hematemesis, melena and bright red blood per rectum or "coffee grounds" aspirated from feeding tube)
- Fever (rectal temperature higher than38.5oC)
- Energy intake (kcal per day)
- Protein intake (g per day)
- Mortality (death)
- Ventilator-associated pneumonia
- Bacteremia (recognized pathogen isolated from blood culture and not related to infection at another site; fever higher than 38oC, chills or hypotension and any of following: common skin contaminant isolated from two blood cultures drawn on separate occasions and organism not related to infection at another site, common skin contaminant isolated from blood culture with intravascular access plus appropriate antimicrobial therapy or positive antigen test on blood and organism not related to infection on another site).
EN feeding tube placement (gastric vs. duodenal).
Same feeding protocol for both treatment groups:
- Tubes were placed by resident physicians and radiographically checked for placement
- Duodenal: Tube was placed at or beyond second portion of duodenum; the pH level also checked (pH of six or higher indicated duodenum). If gastric residuals were more than 100ml, another radiograph was taken to confirm duodenal placement.
- Nasogastric: pH less than six
- Ireton-Jones equation used to estimate energy needs and determine target nutrition rate
- Continuous tube feeding using an enteral pump.
- 62 NG feeds (69.4% male)
- 59 nasoduodenal feeds (71.2% male).
Attrition (Final N)
121 (no attrition).
- NG group: 67.9±15.3 years
- Nasoduodenal group: 70.0±13.1 years.
Other Relevant Demographics
- APACHE II score mean 20.3±6.9 NG vs. 20.5±6.4 nasoduodenal (P=0.86)
- NS differences at baseline in:
- Serum albumin (P=0.82)
- ICU day when feeding commenced: NG group 3.4±1.8 vs. nasoduodenal group 3.6±2.2 (P=0.58)
- Current medications:
- Prokinetic agents (P=0.84)
- PPI or H2 antagonist (P=0.71)
- Antibiotics (P=0.73)
- Sedatives (P=0.69)
- Opioids (P=0.42)
- Patients with diabetes (P=0.69).
BMI: NG 23.1±4.1 vs. nasoduodenal group 23.5±5.8 (P=0.68).
Statistical Significance of Group Difference
Energy Intake (kcal per day)
Protein intake (g per kg per day)
|Mortality||26 (44.1%)||24 (38.7%)||P=0.55|
|Bacteremia||3 (5.1%)||3 (4.8%)||P=0.95|
|Bacteremia per 1,000 catheter day||3.4||5.6||P=0.95|
|Ventilator-associated pneumonia||5 (8.5%)||15 (24.2%)||P=0.02|
|Ventilator-associated Pneumonia per 1,000 ventilator days||3.1||8.6||P=0.01|
- Nasoduodenal group had higher mean percentage of daily goal kcal feed (95±5%) vs. NG group (83±6%) P=0.003
- Nasoduodenal group reached goal rate sooner than NG group (32.4±27.1 hours vs. 54.5±51.4 hours; P=0.004)
- Nasoduodenal group had less vomiting [1/62 (1.7%)] vs. NG [8/59 (12.9%)]; P=0.01.
Patients with nasoduodenal EN have greater intake of calories and protein and reach feeding goals earlier than those with NG tube placement. In addition, they have less vomiting and ventilator-associated pneumonia.
|University/Hospital:||Kaohsiung Veterans General Hospital|
Quality Criteria Checklist: Primary Research
|1.||Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies)||Yes|
|2.||Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about?||Yes|
|3.||Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice?||Yes|
|4.||Is the intervention or procedure feasible? (NA for some epidemiological studies)||Yes|
|1.||Was the research question clearly stated?||Yes|
|1.1.||Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified?||Yes|
|1.2.||Was (were) the outcome(s) [dependent variable(s)] clearly indicated?||Yes|
|1.3.||Were the target population and setting specified?||Yes|
|2.||Was the selection of study subjects/patients free from bias?||Yes|
|2.1.||Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study?||Yes|
|2.2.||Were criteria applied equally to all study groups?||Yes|
|2.3.||Were health, demographics, and other characteristics of subjects described?||Yes|
|2.4.||Were the subjects/patients a representative sample of the relevant population?||Yes|
|3.||Were study groups comparable?||Yes|
|3.1.||Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT)||Yes|
|3.2.||Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline?||Yes|
|3.3.||Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.)||Yes|
|3.4.||If cohort study or cross-sectional study, were groups comparable on important confounding factors and/or were preexisting differences accounted for by using appropriate adjustments in statistical analysis?||N/A|
|3.5.||If case control study, were potential confounding factors comparable for cases and controls? (If case series or trial with subjects serving as own control, this criterion is not applicable.)||N/A|
|3.6.||If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")?||N/A|
|4.||Was method of handling withdrawals described?||Yes|
|4.1.||Were follow-up methods described and the same for all groups?||Yes|
|4.2.||Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.)||Yes|
|4.3.||Were all enrolled subjects/patients (in the original sample) accounted for?||Yes|
|4.4.||Were reasons for withdrawals similar across groups?||N/A|
|4.5.||If diagnostic test, was decision to perform reference test not dependent on results of test under study?||N/A|
|5.||Was blinding used to prevent introduction of bias?||Yes|
|5.1.||In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate?||Yes|
|5.2.||Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.)||Yes|
|5.3.||In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded?||N/A|
|5.4.||In case control study, was case definition explicit and case ascertainment not influenced by exposure status?||N/A|
|5.5.||In diagnostic study, were test results blinded to patient history and other test results?||N/A|
|6.||Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described?||Yes|
|6.1.||In RCT or other intervention trial, were protocols described for all regimens studied?||Yes|
|6.2.||In observational study, were interventions, study settings, and clinicians/provider described?||N/A|
|6.3.||Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect?||Yes|
|6.4.||Was the amount of exposure and, if relevant, subject/patient compliance measured?||Yes|
|6.5.||Were co-interventions (e.g., ancillary treatments, other therapies) described?||Yes|
|6.6.||Were extra or unplanned treatments described?||Yes|
|6.7.||Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups?||Yes|
|6.8.||In diagnostic study, were details of test administration and replication sufficient?||N/A|
|7.||Were outcomes clearly defined and the measurements valid and reliable?||Yes|
|7.1.||Were primary and secondary endpoints described and relevant to the question?||Yes|
|7.2.||Were nutrition measures appropriate to question and outcomes of concern?||Yes|
|7.3.||Was the period of follow-up long enough for important outcome(s) to occur?||Yes|
|7.4.||Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures?||Yes|
|7.5.||Was the measurement of effect at an appropriate level of precision?||Yes|
|7.6.||Were other factors accounted for (measured) that could affect outcomes?||Yes|
|7.7.||Were the measurements conducted consistently across groups?||Yes|
|8.||Was the statistical analysis appropriate for the study design and type of outcome indicators?||Yes|
|8.1.||Were statistical analyses adequately described and the results reported appropriately?||Yes|
|8.2.||Were correct statistical tests used and assumptions of test not violated?||Yes|
|8.3.||Were statistics reported with levels of significance and/or confidence intervals?||Yes|
|8.4.||Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)?||Yes|
|8.5.||Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)?||N/A|
|8.6.||Was clinical significance as well as statistical significance reported?||Yes|
|8.7.||If negative findings, was a power calculation reported to address type 2 error?||No|
|9.||Are conclusions supported by results with biases and limitations taken into consideration?||Yes|
|9.1.||Is there a discussion of findings?||Yes|
|9.2.||Are biases and study limitations identified and discussed?||Yes|
|10.||Is bias due to study's funding or sponsorship unlikely?||Yes|
|10.1.||Were sources of funding and investigators' affiliations described?||Yes|
|10.2.||Was the study free from apparent conflict of interest?||Yes|