CI: Gastric vs. Small Bowel Feeding (2011)
Davies AR, Froomes PRA, French CJ, et al. Randomized comparison of nasojejunal and nasogastric feeding in critically ill patients. Crit Care Med 2002; 30: 586-590
PubMed ID: 11990920![Positive](/lib/img/icon/icomoon/gradient/plus1.png)
To determine whether nasojejunal (NJ) feeding improves tolerance of enteral nutrition compared to nasogastric (NG) by reducing gastric residual volumes (GVR).
Expected to need enteral feedings less than three per day
- Unsuitable for tube passage (facial fracture, coagulopathy)
- Already receiving nutrition support
- Expected to die within 48 hours.
Recruitment
All eligible patients admitted to the ICU from whom informed consent could be obtained (patient or next of kin)
Design
RCT; randomization to gastric or jejunal feeding by sealed envelope
Blinding
Not blinded
Intervention
Tube feeding by gastric or jejunal tube
Statistical Analysis
- Power analysis: 35 patients needed in each group to yield 80% power of detecting 50% relative decrease in rate of intolerance of EN
- Fisher's exact test for discreet variables
- Two-sample T-tests or Mann-Whitney U tests for continuous variables
- P<0.05 regarded as significant.
Timing of Measurements
- Check GRV every six hours
- Xray tubes every three hours
- Replace blocked tubes
- Hold feeds for:
- Vomiting,
- GRV>250ml
- Formula in ET tube or tracheostomy
- Dye in NG asp if NJ tube
- Intolerance=hold EN if vomiting, GRV>250ml four times in 48 hours or GRV>2,000 mL per 48 hours.
Dependent Variables
- Formula volume delivered (first 24 hours, 48 hours)
- Time to reach target rate (mean±SE)
- Number who met criteria for intolerance of EN (%)
- Total GRV (first 24 hours, 48 hours) mean±SE
- Patients with at least one GRV>150mL in first 48 hours (%)
- New onset pneumonia (%)
- New onset SIRS (%)
- New onset severe sepsis (%)
- New onset septic shock (%)
- New onset acute renal failure (%)
- GI bleeding (%)
- Diarrhea (%).
Independent Variable
Feeding tube placement (gastric or small bowel)
Control Variables
- Dietitian calculated target nutrition rate to nearest 5mL per hour using Harris Benedict equation
- Initial delivery rate 20mL per hour and advanced by 20mL per four hours in all patients until target rate reached
- Same iso-osmolar EN formula used (4,200kJ and 40g protein/L unless clinical care dictated need for alternate formula
- All EN delivered by pump
- EN through NJ tube had dye added to make it visible in gastric aspirate.
- Initial N: 73 enrolled over two years
- NG 39 (62% male)
- NJ 34 (77% male)
- Final n (attrition):
- NG 35 (10%)
- NJ 31 (11%)
- Age:
- NG 53.5±2.9 years
- NJ 55.7±3.63 years
- Ethnicity: Not described
- Other relevant setting characteristics: Single ICU of a university-affiliated hospital over a two-year period
- Anthropometrics or other relevant subject characteristics:
- APACHE II scores at admission similar (P=0.86)
- NG group 20.7±1.3
- NJ group 20.4±1.5
- Significant difference in time of admission to initiation of EN (P=0.01)
- NG group 54.5±4.9 hours
- NJ group 81.2±13.4 hours
- Duration of EN (P=0.82)
- NG 8.2±1.1 days
- NJ 8.6±1.2
- Mortality rate
- NG 5/39 (13%) (P=0.58)
- NJ 4/34 (11%)
- ICU LOS (P=0.11)
- NG 10.4±1.2 days
- NJ 13.1±1.8 days
- APACHE II scores at admission similar (P=0.86)
- Location: Australia.
Key findings
- GRV reduced with NJ feeds
- 69% patients on NG tolerated feeds vs. 87% with NJ tube (trend, but NS difference)
- Trend toward significance in new onset of severe sepsis and intolerance of EN.
Significant Outcomes NG vs. NJ Enteral Feeding Route
Variable |
NG (n=35) |
NJ (n=31) |
P-Value |
Intolerance of EN (%) | 11/35 (31%) | 4/31 (13%) | P=0.09 |
GRV first 24 hours (mean±SE) | 491±91 | 197±47 | P=0.02 |
GRV first 48 hours (mean±SE) | 975±154 | 517±109 | P=0.02 |
New onset severe sepsis (%) | 10/35 (29%) | 3/31 (10%) | P=0.07 |
Other findings
- Size of study groups inadequate to test small to moderate differences in septic complication incidence, but there was a trend toward lower incidence of severe sepsis (NG 29% vs. SB 10%; P=0.07)
- No significant difference in amount of formula delivered in first 24 or 48 hours (P=0.59 and P=0.48, respectively)
- No difference in time to reach target goal rate (P=0.48)
- No difference in percent intolerance (P=0.09)
- NG 11/35 (31%)
- NJ 4/31(13%)
- No difference in volume formula delivered (P=0.48) or time to reach target rate (P=0.60)
- No difference in incidence of new-onset pneumonia (only three cases of new onset pneumonia (gastric group 1/39 vs. 2/34 in SB group; P>0.05)
- No difference in LOS with gastric 10.4±1.2 days vs. SB 13.1±1.8 days (P=0.11)
- No difference in occurrence of SIRS, septic shock, acute renal failure, GI bleeding or diarrhea (P>0.05).
Critically ill patients should first have EN via NG tube, but protocol should tolerate a hither GRV. If high GRV or vomiting persist, insert an NJ tube. Most patients will reach nutritional goal within 24 hours.
University/Hospital: | Austin and Repatriation Medical Centre (Australia) |
Underpowered to test infectious complications; did not test mortality, LOS (but reported in demographics in Table 1); did not report days on mechanical ventilation or cost of care outcomes.
Quality Criteria Checklist: Primary Research
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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 | |
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 | |
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 | |
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 | |
4. | Is the intervention or procedure feasible? (NA for some epidemiological studies) | Yes | |
Validity Questions | |||
1. | Was the research question clearly stated? | 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 | |
1.1. | 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 | |
1.2. | Was (were) the outcome(s) [dependent variable(s)] clearly indicated? | Yes | |
1.3. | Were the target population and setting specified? | Yes | |
1.3. | Were the target population and setting specified? | Yes | |
2. | Was the selection of study subjects/patients free from bias? | 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 | |
2.1. | 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 | |
2.2. | Were criteria applied equally to all study groups? | Yes | |
2.3. | Were health, demographics, and other characteristics of subjects described? | 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 | |
2.4. | Were the subjects/patients a representative sample of the relevant population? | Yes | |
3. | Were study groups comparable? | 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 | |
3.1. | 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 | |
3.2. | 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 | |
3.3. | 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 | |
3.4. | 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 | |
3.5. | 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 | |
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. | Was method of handling withdrawals described? | Yes | |
4.1. | Were follow-up methods described and the same for all groups? | 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 | |
4.2. | 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? | ??? | |
4.3. | Were all enrolled subjects/patients (in the original sample) accounted for? | ??? | |
4.4. | Were reasons for withdrawals similar across groups? | ??? | |
4.4. | Were reasons for withdrawals similar across groups? | ??? | |
4.5. | If diagnostic test, was decision to perform reference test not dependent on results of test under study? | 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. | 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 | |
5.1. | 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 | |
5.2. | 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 | |
5.3. | 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 | |
5.4. | 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 | |
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. | 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 | |
6.1. | 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 | |
6.2. | 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 | |
6.3. | 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 | |
6.4. | 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 | |
6.5. | Were co-interventions (e.g., ancillary treatments, other therapies) described? | Yes | |
6.6. | Were extra or unplanned treatments 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 | |
6.7. | 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 | |
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. | 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 | |
7.1. | 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 | |
7.2. | 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 | |
7.3. | 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 | |
7.4. | 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 | |
7.5. | 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 | |
7.6. | Were other factors accounted for (measured) that could affect outcomes? | Yes | |
7.7. | Were the measurements conducted consistently across groups? | 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. | 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 | |
8.1. | 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 | |
8.2. | 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 | |
8.3. | 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)? | 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)? | No | |
8.5. | Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)? | 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? | 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 | |
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. | Are conclusions supported by results with biases and limitations taken into consideration? | Yes | |
9.1. | Is there a discussion of findings? | Yes | |
9.1. | Is there a discussion of findings? | Yes | |
9.2. | Are biases and study limitations identified and discussed? | 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. | Is bias due to study's funding or sponsorship unlikely? | Yes | |
10.1. | Were sources of funding and investigators' affiliations described? | Yes | |
10.1. | Were sources of funding and investigators' affiliations described? | Yes | |
10.2. | Was the study free from apparent conflict of interest? | Yes | |
10.2. | Was the study free from apparent conflict of interest? | Yes | |