EAL

CI: Gastric vs. Small Bowel Feeding (2011)

Citation:

Montejo JC, Grau T, Acosta J, et al. Multicenter, prospective, randomized, single-blind study comparing the efficacy and gastrointestinal complications of early jejunal feeding in critically ill patients. Crit Care Med 2002; 30: 796-800.

PubMed ID: 11940748

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 incidence of enteral feeding-related GI complications, efficacy of diet administration, and incidence of nosocomial pneumonia in patients fed in stomach vs. jejunum.

Inclusion Criteria:

Need enteral nutrition less than five days in ICU
Age>18 years
No contraindications for enteral feeding
Consent from patient or relative.

Exclusion Criteria:

Anatomical disruptions of the GI tract
Previous GI surgery
Contraindication (unspecified) for enteral nutrition or gastric endoscopy
<18 years of age
Did not give consent.

Description of Study Protocol:

Recruitment

Patients in 14 ICUs at university medical centers

Design

RCT

Prospective
Multicenter
Randomized by hospital (numbers generated by computer).

Blinding

Single-blind

Intervention

Gastric vs. small bowel feeding

Statistical Analysis:

Power analysis: Sample size n=152 to detect decrease in nosocomial pneumia from 48% to 20% with 80% power and 5% significance
Statistical analyses performed by independent institution
Intermediate analysis after 60% of subjects recruited
Intent-to-treat analysis
Continuous data assessed for normality
- Two-tailed Student's T-tests for normal data
- Mann-Whitney for non normal distributions
Chi-square test with Yates correction for portions
Relative risk calculated for outcome end-points.

Data Collection Summary:

Timing and method of measurements

Gastric tube placed at admission
SB tube placed within 36 hours of admission
Removed from study for complication (included blockage, accidental withdrawal, dislodgement).

Dependent variables (outcomes)

Efficacy of diet administration (ratio of administered or prescribed formula)
GI complications (abdominal distension, vomiting, diarrhea, constipation,high gastric residuals>300mL)
Mortality (death)
Length of stay (days)
Nosocomial pneumonia (percentage)
Multiple organ dysfunction syndrome (at day five and at discharge).

Independent Variables (intervention or procedure)

Gastric or SB feeding

Description of Actual Data Sample:

Initial N (% male): 101 (70% male)
Final N (% attrition): 81 (20% attrition)
Age: 58±17 years
Ethnicity: Not described
Other relevant setting characteristics: None mentioned
Anthropometrics or other relevant subject characteristics:
- APACHE II Score 18±7
- MODS score 8±3
Location: Spain.

Summary of Results:

Key findings

No differences in feeding duration, ICU LOS or mortality

**Gastric vs. SB Feedings**
Outcome	Gastric n=43	SB n=38	Statistical Difference
Nosocomial pneumonia (%)*	36%	40%	P=0.4
High gastric residuals >300mL, (%)	49%	2%	P<0.001
Mortality (%)	43%	38%	P=0.6
Length of stay (days)	18±16	15±10	P=0.2
MODS score at day five	4.2±3.8	4.9±3.9	P=0.4

*Power analysis indicated n=152 needed for 80% power at 5% significance for nosocomial pneumonia

Other findings

NS difference in efficacy of diet administration (ratio of administered or prescribed formula) with 86±23% for gastric vs. 83±25% for SB (P=0.7).

Author Conclusion:

GI complications are reduced in ICU patients fed in the jejunum
There is learning curve for better results with post-pyloric access
Does not decrease nosocomial pneumonia.

Funding Source:

Industry:

Novartis Consumer Health

Pharmaceutical/Dietary Supplement Company:

University/Hospital:

Hospital Universitario

In-Kind support reported by Industry:

Yes

Reviewer Comments:

Study was underpowered; enrolled 101 and Power analysis predicted 151 needed
Author says up to 400 patients or more may be needed to answer question re pneumonia.

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?		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
	4.3.	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?		Yes
	5.1.	In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate?	Yes
	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?	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?	N/A
	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?	N/A
	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)?	N/A
	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?	Yes
	10.2.	Was the study free from apparent conflict of interest?	Yes