• Increase Font Size
  • Decrease Font Size
  • View as PDF

CI: Monitoring Criteria: Gastric Residual Volume (2006)

Citation:

Neumann DA, DeLegge MH. Gastric vs small bowel tube feeding in the intensive care unit: A prospective comparison of efficacy. Crit Med 2002; 30: 1,436-1,438.

PubMed ID: 12130958
 
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 compare the outcomes of intensive care unit patients fed through a masogastric (ng) vs. nasal-small bowel (SB) including the time from tube placement to feeding, time to reach goal rate and adverse events.

Inclusion Criteria:
  • Medical ICU patients
  • Need enteral feeding.
Exclusion Criteria:
  • Gastrointestinal obstruction
  • Iileus
  • Pancreatitis
  • Gastroparesis
  • No consent.
Description of Study Protocol:
  • Recruitment: MICU patients who met inclusion criteria
  • Design: RCT; prospective randomization by computer-generated, individually-numbered and sealed envelopes
  • Blinding: Not blinded.
Intervention
  • Gastric or small bowel feeding tube
    • All feeds started at 30ml per hour and advanced 10ml per hour every seven hours until reaching goal rate
    • Feedings were held for GRV over 200ml.
Statistical Analysis
  • Wilcoxon's rank sum analysis
  • P<0.05 was considered significant.
Data Collection Summary:

Timing and Method of Measurements  

  • Times recorded in hours from successful tube insertion, onset of feeding, achievement of goal rate and termination of feeding
  • 60-ml syringe used to measure GRV (but no time specified as to frequency of measure).
Dependent Variables (Outcomes)
  • Number of attempts to place feeding tube
  • Frequency of GRV above 200ml
  • Time until feeding started from initial placement (hours)
  • Time to reach goal from successful tube placement (hours)
  • Clinically-significant aspiration [new infiltrate on chest radiograph subsequently treated with antibiotics against oral flora or suctioning of tube feeding formula (had blue dye) from oral pharynx or airway].

Independent Variables (Intervention or Procedure)

Gastric or SB feeding tube.

Description of Actual Data Sample:

Initial N (Percentage Male)

  • 60 (50% male)
  • N=30 (50% male) for both gastric and SB feeding groups.
Final N (Percentage Attrition)
No attrition.
Age
  • P=0.719
  • Gastric Feeding Group: 58.1±15.4 years
  • SB Feeding Group: 59.6±15.3 years.

Ethnicity

Not described.

Other Relevant Setting Characteristics
None.
Anthropometrics or Other Relevant Subject Characteristics
  • Illness severity not described
  • 20-bed MICU.
Location
Carolinas Medical Center, Charlotte, NC.
Summary of Results:

Key Findings

Gastric feeding is not higher in adverse effects than SB feeding: The feeding tube can be placed more quickly and feeding goals reached sooner. 

Outcomes of Gastric vs. Small Bowel Feeding

Outcome Gastric (N=30) SB    (N=30) Statistical Significance
Attempts to Place Feeding Tube (median)
1.1±0.3
1.9±0.7
 P<0.001
Frequency of GRV>200ml (percentage)

13.3%
20%
 P=0.488

Time from Initial Placement until Feeding Started (hours)
11.2±11.0
27.0±22.6
 P<0.001

Time to Reach Goal from Initial Tube Placement (hours)
28.8±15.9
43.0±24.1
 P=0.024
Clinically Significant Aspiration
0/30 (0%)
1/30 (3.3%)
 P=1.00
 
Other Findings
  • No data for mortality, incidence of pneumonia, LOS, days on mechanical ventilation or cost of care
  • No significant difference in adverse events.
Author Conclusion:
  • No difference in aspiration or other adverse outcomes in gastric vs. SB feedings
  • Gastric feeds can be started faster and NG feeds offer safe and efficient means of enteral nutrition in the majority of medical ICU patients.
Funding Source:
University/Hospital: Allegheny General Hospital, Medical University of South Carolina
Reviewer Comments:

No power analysis.

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? 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? 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? 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? N/A
  7.7. Were the measurements conducted consistently across groups? N/A
8. Was the statistical analysis appropriate for the study design and type of outcome indicators? ???
  8.1. Were statistical analyses adequately described and the results reported appropriately? ???
  8.2. Were correct statistical tests used and assumptions of test not violated? ???
  8.3. Were statistics reported with levels of significance and/or confidence intervals? N/A
  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