CI: Gastric vs. Small Bowel Feeding (2011)
White H, Sosnowski K, Tran K, Reeves A, Jones M. A randomised controlled comparison of early post-pyloric vs. early gastric feeding to meet nutritional targets in ventilated intensive care patients. Crit Care. 2009; 13(6): R187. Epub: 2009 Nov 25. PMID: 19930728.PubMed ID: 19930728
To compare outcomes in mechanically ventilated, critically ill patients in a MICU when they were fed by EN through gastric or post-pyloric access.
- 18 years of age or more
- Expected to require mechanical ventilation 24 hours or longer.
- Ischemic bowel
- Bowel obstruction
- Exacerbation of inflammatory bowel disease
- Acute variceal bleeding
- At high risk for anastomotic leak.
- All eligible patients admitted to eight-bed MICU over 12-month period
- Patients remained in the study until EN ceased or discharged from ICU.
- Single site, prospective randomized controlled trial
- Randomization by computer-generated random number sequence and sealed opaque envelope.
Patients by several physicians; most were not involved in the study.
Gastric vs post-pyloric EN feeding tube:
- EN feeding algorithm and type of formula and goal rate determined by dietitian
- Height used to estimate IBW; used adjusted body weight for obese patients
- Algorithm prescribed 30kcal per kg IBW and 1.5g protein per kg IBW unless liver or renal failure was present, in which case protein was 1 to 1.2g per kg
- EN initiated at 40ml per hour
- Gastric feeding tubes aspirated for GRV every four hours; if GRV is less than 200ml, rate increased to target rate. If GRV is more than 200ml, a prokinetic agent was given (10mg metaclopramide initially and followed by erythromycin 250mg if large GRV continued. If GRV remained at more than 200ml, a post-pyloric feeding tube was inserted. If that was not tolerated, patient was given PN.
- Continuous variables reported as median and IQR and compared using Wilcoxon-rank sum test
- Multiple regression model used to compare continuous outcomes of study with adjustments for baseline variables
- Log transformation of positively skewed outcome data prior to regression analysis
- Fisher's exact test to compare binary variables
- Logistic regression to compare mortality rates in two groups
- Primary analysis by intent-to-treat
- Secondary per-protocol analysis was also completed
- Sample size of 50 per treatment group estimated to have 90% power to detect halving of time to reach feeding goals at significance level of 5% and attrition rate of 10%
Timing of Measurements
Length of stay and mechanical ventilation (days).
- Average daily energy deficit (kcal) (Power analysis on this variable)
- Time to initiate feeding (hours)
- Time to reach goal from feeding initiation (hours)
- Time to reach goal from admission (hours)
- Average daily energy required (kcal)
- Average daily energy deficit (kcal).
Gastric or post-pyloric feeding tube placement.
APACHE II score (higher in post-pyloric group).
- Gastric group: N=57
- Post-pyloric group: N=51.
Attrition (Final N)
104 intent-to-treat analysis:
- Gastric group: N=54 (52% male)
- Post-pyloric group: N=50 (48% male).
- Gastric median age: 54 (IQR 40 to 63)
- Post-pyloric median age: 50 (IQR 45 to 70).
Other Relevant Demographics:
- APACHE II scores (P<0.005)
- Gastric: 24.5 (20 to 28)
- Post-pyloric: 30 (25 to 35)
- LOS (P>0.05)
- Gastric median: 5.02 (IQR 1.98 to 9.99)
- Post-pyloric median: 5.3 (IQR 2.73 to 9.89).
Early post-pyloric feeding offers no nutritional advantage over gastric feeding.
Gastric Group (N=54)
Post-pyloric Group (N=50)
Statistical Significance of Group Difference
|Time to initiate feeds (hours)||
Time to reach target feeding rate from admission (hours)
Average daily energy deficit (kcal)
|Average daily protein deficit (g)||
|Mortality (adjusted for APACHE II score)||5/54 (9.2%)||11/50 (22%)||OR, 2.15 (95% CI: 0.65-7.07), P=0.2|
|VAP||11/54 (20%)||5/50 (10%)||P=0.18|
|LOS (days)||4.97 (2.0-10.0)||5.57 (2.8-9.8)||P>0.05|
|Mechanical ventilation (days)||3.43 (1.6-8.4)||4.92 (2.3-8.2)||P>0.05|
*Not significant in multiple regression.
Early post-pyloric feeding offers no advantage in nutritional intake or clinical outcomes.
|University/Hospital:||Logan Hospital, University of Queensland, Australia|
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?||No|
|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?||Yes|
|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?||No|
|5.1.||In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate?||N/A|
|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?||N/A|
|6.6.||Were extra or unplanned treatments described?||N/A|
|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)?||Yes|
|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?||Yes|
|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|