CI: Initiation of Enteral Nutrition (2012)
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The research purpose was to determine safety and impact of EN initiated within 36 hours of injury and completion of acute resuscitation on patients with open abdomens.
- Aged 16 years or older
- Blunt trauma wound with open abdomen (required damage-control laparotomy or decompression for abdominal compartment syndrome, without primary fascial closure)
- Arrival at hospital within six hours of injury
- Either hypotension (systolic BP, 90mmHg) or elevated base deficit at least 6
- Blood transfusion within 12 hours of injury
- Body region exclusive of brain with Abbreviated Injury Scale score of at least 2
- Survival of at least 48 hours and treated with an open abdomen
- No transmural intestinal injury
- Intact cervical spinal cord to exclude those with isolated severe head injuries or spinal cord injuries.
- Aged over 16 years
- Arrival at hospital more than six hours after injury occurred
- Survival of less than 48 hours
- No open abdomen
- Transmural intestinal injury
- Isolated severe head injury or spinal cord injury.
- Recruitment: Patients at seven trauma centers participated between April 2004 and March 2007
- Design: Retrospective cohort study
- Blinding used: Not applicable
- Intervention: Exposure to EN within 36 hours.
Statistical Analysis
- Relationship between EN within 36 hours and injury characteristics
- X2 analysis for categorical variables
- T-test for continuous variables.
- All variables with P<0.1 on uni-variate analysis were entered into a forward step-wise regression model to identify risk factors for delay in abdominal closure and development of pneumomia: Cox proportional hazards regression was used to evaluate the effect of EN on time to development of ventilator-associated pneumonia.
Dependent Variables
- Multi-organ dysfunction (MOD score)
- LOS (ICU and hospital days)
- Mortality (hospital death)
- Ventilator-associated pneumonia
- Abdominal closure (patients closed and day of closure, laparotomies).
Independent Variables
Early enteral feeding.
Control Variables
Step-wise regression for multi-variate analyses.
Initial N
- 100 trauma patients with open abdomen
- 32 (65% male) with EN within 36 hours
- 68 (73.5% male) with EN later than 36 hours
- P=0.416.
Attrition (Final N)
Not applicable.
Age
- Early EN: 40±17 years (N=32)
- No early EN: 39±18 years (N=68).
Ethnicity
No difference by group (P>0.05)
- Early EN
- Caucasian: 93.8%
- African-American: 3.1%
- Asian: 3.1%
- Other: 0%.
- No early EN
- Caucasian: 89.7%
- African-American: 5.9%
- Asian: 1.5%
- Other: 2.9%.
Other Relevant Demographics
ISS±SD
- EN feeds: 34±13
- Controls: 36±13
- P=0.786.
Anthropometrics
BMI
- Early EN: 28±1.0
- No early EN: 29±0.8
- P=0.696.
Location
USA.
Key Findings
No difference in outcomes except for ventilator-associated
Variables |
Early EN |
Control Group |
Statistical Significance of Group Difference |
Days on Mechanical Ventilation |
17.4±2.7 |
19.3±3.0 |
P=0.668 |
ICU LOS |
20.7±2.7 |
22.6±3.0 |
P=0.689 |
Hospital LOS |
32.9±4.0 |
33.0±3.3 |
P=0.992 |
Maximum Multiple Organ Dysfunction Score |
7.3±.05
|
8.0±0.4
|
P=0.274 |
Ventilator-Associated Pneumonia (%) |
43.8%
|
72.1%
|
P=0.008 |
Mortality |
12.5%
|
23.5%
|
P=0.285 |
Other Findings
No difference in patients with abdominal closure,day of closure or number of laparotomies.
- It is safe to provide early EN to patients with severe trauma and there is no effect on abdominal closure rate
- Reduction of ventilator-associated pneumonia is a benefit of early EN.
Government: | U54 GM062119-1 |
University/Hospital: | Massachusetts General Hospital |
This research was secondary analysis of data from a prior study.
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 | |
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? | Yes | |
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? | N/A | |
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? | Yes | |
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? | Yes | |
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? | 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 | |
6.5. | 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? | 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)? | N/A | |
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? | N/A | |
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 | |