EAL

CI: Gastric vs. Small Bowel Feeding (2011)

Citation:

Montecalvo MA, Steger KA, Farber HW, et al. Nutritional outcome and pneumonia in critical care patients randomized to gastic vs. jejunal tube feedings. Crit Care Med. 1992; 20: 1,377-1,387.

PubMed ID: 1395657

Study Design:

Randomized Controlled Trial

Class:

A - Click here for explanation of classification scheme.

Quality Rating:

POSITIVE: See Quality Criteria Checklist below.

Research Purpose:

To compare nutritional status, gastric colonization and rates of nosocomial pneumonia in ICU patients fed by gastric vs. SB feedings.

Inclusion Criteria:

Less than three days admission
No contraindication to EN tube placement or endoscopy
No GI bleeding
No gastric EN feeds within the past 72 hours
Consent.

Exclusion Criteria:

Did not meet inclusion criteria.

Description of Study Protocol:

Recruitment

10-month period September 1989 to June 1990 in surgical and medical ICUs
Considered all patients with indication to begin EN who were patients in ICU.

Design

Randomized control trial
Computer-generated randomization code to receive gastric or SB tube feeding. Five patients initially randomized and fed by jejunal tube crossed over to gastric feeding after jejunal tube was displaced and could not be replaced (crossovers analyzed for days they received feeding by route to which they were initially randomized; excluded from study on day of their crossover).

Blinding

Cultures reviewed in blinded fashion for determination of pneumonia and other infection.

Intervention

EN by gastric or SB (jejunal) feeding tube.

Statistical Analysis

Continuous variables by two-tailed student's T-test
Categorical variables by two-tailed Fisher's exact test
Paired T-test (two-tailed) used to compare changes in prealbumin concentrations at time of randomization and during EN for each patient.

Data Collection Summary:

Timing and Method of Measurements

Baseline: Demographic characteristics, diagnosis, severity of illness at ICU admission, nutrition assessment (subjective global assessment, determination of present weight, percent IBW, serum albumin and prealbumin concentrations, total circulating lymphocyte count, delayed cutaneous hypersensitivity testing with a 10 antigen skin panel, creatinine-height index and nitrogen balance studies)
Weekly: Percent IBW, serum albumin, prealbumin, nitrogen balance, creatinine height index
Daily: Vital signs including temperature, blood pressure.

Dependent Variables (Outcomes)

Tube feeding days
Tube feeding volume (ml per day)
Kcal per day
Daily goal caloric intake (%)
Increase in prealbumin (mg per dL)
Number of times tube clogged
Number of patients with tube replaced
Number of patients with diarrhea
Number of patients vomiting
Number of times GRV more than 250ml noted
GI bleeding.

Independent Variables (Intervention or Procedure)

Gastric or SB feeding tube placement.

Description of Actual Data Sample:

Initial N

38 (61% male).

Age

Significantly different for age, P<0.05.

Gastric (N=19): 44.8±15.9
SB (N=19): 50.5±21.5.

Ethnicity

White 63%
Black 34%
Other 3%

Other Relevant Setting Characteristics

Mean time from ICU admission to onset of EN 3.9±2.3 days for gastric group vs. 5.5±3.1 days for SB group (P>0.05).

Anthropometrics

APACHE II score: Gastric 21.7±8.2 vs. SB 24.0±6.7
Glasgow Coma Scale: Gastric 9.3±3.9 vs SB 9.5±4.5.

Location

Boston, MA.

Summary of Results:

Key Findings

Incidence of pneumonia not significantly different for gastric vs SB feeding (P>0.05).

Outcome	Gastric (N=19)	SB (N=19)	Statistical Significance
Daily goal caloric intake (%)	46.9±25.9	61.0±17.0	P<0.05
Increase in prealbumin (mg per dL)	3.1±4.9	9.0±7.5	P<0.05
Pneumonia (%)	0/19 (0%)	2/19 (10.5%)	P<0.05

Other Findings

NS differences (P>0.05) for tube feeding days, tube feeding volume (ml per day), kcal per day, number of times tube clogged, number of patients with tube replaced, patients with diarrhea, number of days of diarrhea, vomiting, number of GRV more than 250ml, GI bleeding
Questionnaire administered to 87 nurses revealed significant reasons for turning off tube feeding included vomiting (gastric and SB), absent bowel sounds (SB), flat or Trendelenburg position (SB) or eight hours before surgery (SB) P<0.05.

Author Conclusion:

Patients fed by tube in SB received higher proportion of daily goal kcal intake and had greater increase in prealbumin.

Funding Source:

University/Hospital:

Boston University School of Medicine, Boston City Hospital and University Hospital

Reviewer Comments:

The author concluded patients fed by jejunal tube had lower rate of pneumonia; however, it was not statistically significant (P>0.05) per Figure 1 on page 1,382. In discussion, author stated that based on overall rate of pneumonia in the study, it would require 313 patients in each group to achieve a statistically significant differences with 80% power and α=0.05.

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?	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?		Yes
	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