EAL

CI: Initiation of Enteral Nutrition (2012)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To determine the efficacy of administering early jejunal enteral nutrition support in the head-injured patient by examining caloric intake, nitrogen intake and balance, and metabolism.

Inclusion Criteria:

Patients sustaining severe head injuries with a six-hour post-admission Glasgow Coma Scale (GCS) score less than 10
Informed consent provided by a family member or legal guardian.

Exclusion Criteria:

Those patients sustaining head injuries with a GCS score of more than 10 six-hours post-admission
Those patients with families or guardians not giving informed consent to participate in the trial.

Description of Study Protocol:

Randomized patients to the trial according to day of admission to the hospital. Those admitted on odd days were randomized into the control group and those admitted on the even into the experimental group.
Due to circumstances, four patients ineligible for the experimental group were placed in the control group and four patients randomized to the control group were placed in the experimental group.
The experimental group received feedings initiated at estimated caloric requirements within 36 hours post-admission by a separate nasojejunal feeding tube placed fluoroscopically. All patients in the experimental group received Vital HN formula. Subjects received continuous enteral feeding and did not have feedings withheld for elevated residuals or diarrhea.
The control group had gastric feedings initiated after Day three or when gastric function returned. In the event that prolonged gastric intolerance persisted longer than five days, jejunal feedings were administered. Control subjects received various feeding solutions (Vital HN, Isocal HCN, and Vivonex TEN). Feedings were stopped for residuals greater than 150ml.
Subjects were studied for the first seven days following injury or until transfer from the ICU.

Data Collection Summary:

REE determined by indirect calorimetry, total urinary nitrogen excretion, serum albumin, electrolytes, glucose, blood urea nitrogen and complete blood cell count
Outcome(s) and other measures:
- Length of hospital stay
- Infection
- Caloric intake.

Description of Actual Data Sample:

32 total head-injured patients were involved in the study
- 17 experimental subjects
- 15 control subjects
Mean age of patients in control group (14 men, one woman) was 27.8±9.3 years
Mean age of patients in the experimental group (15 men, two women) was 25.5±13.2 years.

Summary of Results:

Length of Hospitalization

Median length of ICU stay was seven days (range four to 19 days) for the experimental group and 10 days for the control group
Length of stay also significantly varied when the groups were compared by a three-way chi-square analysis of patients with lengths of stay less than one week, one to two weeks, and greater than two weeks (chi-square value = 5.0; dF=2; P=0.05).

Infections

There was less incidence of infection within the experimental group vs. the control group (chi-square value = 9.07; P<0.005)
Three bacterial infections were documented during ICU stay in the experimental group (one case of bronchitis and two cases of pneumonia)
The control group suffered 14 bacterial infections in 10 different patients (bronchitis, 10; pneumonia, three; and ventriculitis, one).

Caloric Intake

A significant difference in caloric intake resulted between the two groups
(Days two to four, P<0.0001; Days five to six, P<0.05)
Daily mean caloric intake of experimental group was 2,102kcal per 24 hours; mean calorie deficit of 3,010kcal for seven days
Daily mean caloric intake of the control group was 1,100kcal per 24 hours; mean calorie deficit of 10,194kcal per seven days. Only eight of the 15 control patients were receiving full caloric demands within seven days.
An improved nitrogen intake and balance was seen in experimental patients due to improved caloric intake.

Experimental

(P<0.001, Days two to four)
Mean nitrogen intake of 11.1g per 24 hours
Mean nitrogen balance of -4.3g per hours.

Control

Mean nitrogen intake of 5.6g per 24 hours
Mean nitrogen balance of -11.8g per 24 hours.

Author Conclusion:

Patients suffering from severe head injury will tolerate jejunal enteral feeding shortly after injury regardless of gastric function
Initiating early enteral nutrition support may significantly reduce the amount of infection seen in head-injured patients, thus leading to a reduced length of hospitalization

Funding Source:

University/Hospital:

Barrow Neurological Institute

Reviewer Comments:

Researchers provided few inclusion or exclusion criteria for subject selection
Small sample size
The concealment for this trial was inadequate.

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?		???
	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?	No
	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.)	No
	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?	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?	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?	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)?	Yes
	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?	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?	???
	10.2.	Was the study free from apparent conflict of interest?	Yes