CI: Monitoring Criteria: Promotility Agents (2006)
To compare GI tolerance to 2 enteral feeding protocols in ICU patients.
- > 3 d ICU stay expected
- age > 16 y
- <3 d in ICU
- Small bowel feeding tube
- Concomitant TPN
- All orogastric (OG) or nasogastric (NG) tubes
- Gastric aspirates q 4 hr
- Group I hold if gastric residual volume (GRV) > 150 ml
- Group II hold if GRV > 250 ml, mandatory prokinetic agent.
- Advance by 25 cc/hr q 2 hr if residual volume okay
- High GRV
Outcome(s) and other measuresPrevalence of above
Of original 96 consecutive pts,
36 NG 150 mg GRV goal
44 NG 250 ml GRV goal + prokinetic (cisapride, domperidone or metoclopramide)
- More frequent high GRV with 150 ml protocol (53% vs 23%, p<0.005)
- Number of intolerance events (emesis + diarrhea + high GRV) greater with 150 ml GRV (38 vs 14, p<0.002).
- % goal nutrient intake received greater in group II, 70 vs 76%, p<0.02.
- Incidence of enteral feeding intolerance is reduced by GRV 250 ml and prokinetic agent.
- Trend towards increased nutrient provision.
No power analysis.
Did not use intent to treat analysis.
Prokinetic agents also have side-effects, cannot be recommended for all patients.
Dietitians could consider recommending prokinetic agent if postpyloric tube cannot be placed.
Says GRV 250 ml can work clinically.
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?||N/A|
|1.2.||Was (were) the outcome(s) [dependent variable(s)] clearly indicated?||N/A|
|1.3.||Were the target population and setting specified?||N/A|
|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?||N/A|
|2.2.||Were criteria applied equally to all study groups?||N/A|
|2.3.||Were health, demographics, and other characteristics of subjects described?||N/A|
|2.4.||Were the subjects/patients a representative sample of the relevant population?||N/A|
|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)||N/A|
|3.2.||Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline?||N/A|
|3.3.||Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.)||N/A|
|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?||No|
|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%.)||N/A|
|4.3.||Were all enrolled subjects/patients (in the original sample) accounted for?||N/A|
|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.)||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?||N/A|
|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?||N/A|
|6.4.||Was the amount of exposure and, if relevant, subject/patient compliance measured?||N/A|
|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?||N/A|
|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?||N/A|
|7.2.||Were nutrition measures appropriate to question and outcomes of concern?||N/A|
|7.3.||Was the period of follow-up long enough for important outcome(s) to occur?||N/A|
|7.4.||Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures?||N/A|
|7.5.||Was the measurement of effect at an appropriate level of precision?||N/A|
|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?||No|
|8.1.||Were statistical analyses adequately described and the results reported appropriately?||N/A|
|8.2.||Were correct statistical tests used and assumptions of test not violated?||N/A|
|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)?||N/A|
|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?||N/A|
|9.||Are conclusions supported by results with biases and limitations taken into consideration?||Yes|
|9.1.||Is there a discussion of findings?||N/A|
|9.2.||Are biases and study limitations identified and discussed?||N/A|
|10.||Is bias due to study's funding or sponsorship unlikely?||Yes|
|10.1.||Were sources of funding and investigators' affiliations described?||N/A|
|10.2.||Was the study free from apparent conflict of interest?||N/A|