CI: Gastric vs. Small Bowel Feeding (2011)

Citation:

Boivin MA, Levy H. Gastric feeding with erythromycin is equivalent to transpyloric feeding in the critically ill. Crit Care Med 2001; 39 (10): 1,916-1,919.

PubMed ID: 11588451
 
Study Design:
Randomized Controlled Trial
Class:
A - Click here for explanation of classification scheme.
Quality Rating:
Positive POSITIVE: See Quality Criteria Checklist below.
Research Purpose:

To determine whether erythromycin added to NG feed regimen can meet nutritional needs as effectively as post-pyloric feeding.

Inclusion Criteria:
  • Age>18 years
  • Informed consent by patient or proxy
  • Projected need for tube feeding >72 hours.
Exclusion Criteria:
  • Patients already being fed
  • Pancreatitis, burns, severe head injury
  • Age<18
  • Not expected to need tube feeding for>72 hours.
Description of Study Protocol:

Recruitment

Medical, surgical and neuroscience ICUs of University of New Mexico Health Sciences Center

Design

RCT; randomized with random number tables in blocks of 10 to gastric feeding with erythromycin or transpyloric feeding

Blinding

None

Intervention

Erythromycin or transpyloric feeding

Statistical Analysis

  • Student's T-test to compare means for normally distributed data
  • Chi square for categorical variables
  • Study designed to have 80% power to detect 20% difference in nutrition provided with α=0.05
  • All P-values two-tailed.

 

 

 

Data Collection Summary:

Timing of Measurements

  • Gastric residual volume every four hours
  • Time to goal: From tube placement to the time goal rate was achieved and successfully continued for four hours.

Dependent Variables

  • Primary:
    • Percentage of goal feeding rate achieved during study period
  • Secondary:
    • Time to goal
    • Daily percentage of goal rate
    • Change in albumin, prealbumin, and PaO2/FIO2 index
    • Survival.

Independent Variables

  • Erythromycin, 200mg IV given eight hours for the 96-hour study period for NG or OG feeding
  • Post-pyloric placement of feeding tube.

Control Variables

ICU dietitian determined EN formula and rate to provide 30kcal per kg to patient (used adjusted body weight for patients >20% above ideal body weight.

Description of Actual Data Sample:
  • Initial N: 80 (45% male)
    • NG+erythromycin group n=40
    • Transpyloric feeding tube n=40
  • Attrition (final N): 38
  • Age: 
    • NG+erythromycin group=48 years
    • Transpyloric=49 years
  • Ethnicity: Not described
  • Other relevant demographics: NS differences  
    • APACHE II score
      • NG+erythromycin group=17
      • Transpyloric=49 years
    • Goal rate: 75ml per hour for both groups
  • Anthropometrics:  
    • NS differences in BMI (27 vs. 29 for NG and transpyloric, respectively)
    • NS differences for albumin (mean 2.1mg/dL), prealbumin
  • Location: New Mexico.
Summary of Results:

Key Finding

Gastric feeding with erythromycin as prokinetic agent is equivalent to transpyloric feeding in meeting nutritional goals of time to reach goal rate, kcal received in 96-hour study period and gastric residual volume measures.

Outcome

NG+Erythromycin

n=39

Transpyloric

n=439

Statistical Significance

 

Time to reach goal rate (hours) 32 33 P>0.05
Goal kcal received in 96-hour study period 74% 67% P>0.05
Number of GRV>150mL  27 24 P>0.05
Number of GRV>400ml 5 8 P>0.05

Other Findings

  • Survival was analyzed as a secondary outcome and there was no significant difference with 18% mortality in each group
  • Abstract reported no difference in LOS. Table 3 reported 14 ICU-free days for each group
  • Abstract reported no difference inventilator-dependent days. Table 3 reported 13 ventilator-free days for each group.

 

Author Conclusion:

Gastric feeding with erythromycin as prokinetic is equivalent to transpyloric feeding in meeting nutritional goals.

Funding Source:
University/Hospital: General Clinical Research Center (NIH Supported)
Reviewer Comments:
Quality Criteria Checklist: Primary Research
Relevance Questions
  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
 
Validity Questions
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? N/A
  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.) N/A
  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? 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? No
  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? N/A
  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