Therapy A randomised controlled comparison of early post-pyloric versus early gastric feeding to meet nutritional targets in ventilated intensive care patients
This review may be edited
Summary
Posted By:	Elizabeth Sweetman and Fiona Simpson
E-Mail:	easweetm@nsccahs.health.nsw.gov.au
Posted Date:	10.06.10
Title:	A randomised controlled comparison of early post-pyloric versus early gastric feeding to meet nutritional targets in ventilated intensive care patients
Authors:	White H, Sosnowski K, Tran K, Reeves A, Jones M.
Reference:	Crit Care. 2009;13(6):R187. Epub 2009 Nov 25
Link:	Click here for a direct link to the paper. A password may be required for access to fulltext.
Abstract:	INTRODUCTION: To compare outcomes from early post-pyloric to gastric feeding in ventilated, critically ill patients in a medical intensive care unit (ICU). METHODS: Prospective randomized study. Ventilated patients were randomly assigned to receive enteral feed via a nasogastric or a post-pyloric tube. Post-pyloric tubes were inserted by the bedside nurse and placement was confirmed radiographically. RESULTS: A total of 104 patients were enrolled, 54 in the gastric group and 50 in the post-pyloric group. Bedside post-pyloric tube insertion was successful in 80% of patients. Patients who failed post-pyloric insertion were fed via the nasogastric route, but were analysed on an intent-to treat basis. A per protocol analysis was also performed. Baseline characteristics were similar for all except Acute Physiology and Chronic Health Evaluation II (APACHE II) score, which was higher in the post-pyloric group. There was no difference in length of stay or ventilator days. The gastric group was quicker to initiate feed 4.3 hours (2.9 - 6.5 hours) as compared to post-pyloric group 6.6 hours (4.5 - 13.0 hours) (P = 0.0002). The time to reach target feeds from admission was also faster in gastric group: 8.7 hours (7.6 - 13.0 hours) compared to 12.3 hours (8.9 - 17.5 hours). The average daily energy and protein deficit were lower in gastric group 73 Kcal (2 - 288 Kcal) and 3.5 g (0 - 15 g) compared to 167 Kcal (70 - 411 Kcal) and 6.5 g (2.8 - 17.3 g) respectively but was only statistically significant for the average energy deficit (P = 0.035). This difference disappeared in the per protocol analysis. Complication rates were similar. CONCLUSIONS: Early post-pyloric feeding offers no advantage over early gastric feeding in terms of overall nutrition received and complications TRIAL REGISTRATION: Clinical Trial: anzctr.org.au:ACTRN12606000367549.
Are the Results Valid?
1. Was the assignment of patients to treatments randomized? ( Was allocation concealment maintained?)
	Yes. Allocation concealment was maintained with a computer generated random number sequence and a sealed opaque envelope technique. Eligible patients were randomly assigned to one of two study groups (gastric or post-pyloric group).
2. Were all patients who entered the trial properly accounted for and attributed at its conclusion?
2a. Was followup complete?
	Yes all patients where accounted for in the results section of this paper. In spite of accounting for all 108 patients, the authors did exclude 4 patients from the primary analysis who were randomised in error (3 patients from the Gastric group and 1 from the Post-pyloric group). The Intention to Treat analysis does apply to not only analysing patients in the groups to which they were randomly allocated, but also analysing all patients regardless of whether they satisfied the entry criteria, received the treatment or deviated from the protocol in some other fashion. Patients who withdraw consent from a trial are exempt from the Intention to Treat analysis provided these patients have also removed all rights to the authors to use their data. ITT guidelines for analysis are present within the CONSORT statement.
2b. Were patients analyzed in the groups to which they were randomized?
	Aside from the patients removed from the primary analysis (as above), all other patients were analysed in the groups to which they were randomised.
3. Were patients, health workers, and study personnel blind to treatment?
	No.
4. Were the groups similar at the start of the trial?
	No. The authors stated differences between the two study groups at baseline. The Post-pyloric Group had a higher Apache II Score than the Gastric Group (30 vs 24.5), Table 1. Patients in the Post-pyloric Group also had a higher incidence of Diabetes (12% vs 6%), Acute Renal Failure (24% vs 17%) and Vasopressor use (54% vs 37%) compared to patients in the Gastric Group. Ideally these variables would be controlled using a logistic regression model.
5. Aside from the experimental intervention, were the groups treated equally?
	Unsure. The authors did not present a table of other therapies received by each study group during the trial. In the results section of this paper the authors do state that the delivery of drugs that affect gastric motility did not differ between groups. Number of days on Fentanyl, Morphine, Metaclopramide or Erythromycin - 2 days (0-5.5 days) in the Gastric Group vs 2 days (0-4.0 days) in the Post-pyloric Group, P = 0.7 Number of days on either Metoclopramide or Erythromycin - 0 days (0-4.5 days) in the Gastric Group vs 0 days (0-2 days) in the Post-pyloric Group, P = 0.6
What are the Results?
1. How large was the treatment effect?
	Primary Outcomes: There were no differences between length of stay or duration of ventilation. The number of deaths were 5 in the gastric group versus 11 in the post-pyloric group giving an odds ratio of 2.86 (95% confidence interval (CI) = 0.92 to 8.89, P = 0.069). Secondary Outcomes: Success Rate of Nurse initiated post-pyloric tubes: 80% success rate of post-pyloric tube placement; 10 patients in the post-pyloric group who did not receive a post-pyloric tube and 4 patients in the gastric group who did receive a post-pyloric tube. Patients who failed a post pyloric insertion were fed via the NG route, but were analysed on an intention to treat basis. Time to initiate feed from admission or ventilation in quicker in Gastric Group 4.3 hrs (2.9-6.5)than Post-pyloric Group 6.6 hrs(4.5-13.0; P = 0.0002 Time to reach feed goals from initiation of feeds in hours, no difference between groups; 4.3 hrs (4.0-5.0) Gastric Group vs 4.1 hrs(3.4-5.0)Post-pyloric Group (P = 0.3) Time to reach feed goals from admission or ventilation in hours quicker in Gastric Group 8.7 hrs (7.6-13.0) vs 12.3 hrs(8.9-17.5)in Post-Pyloric Group; P = 0.004 Average daily energy deficit was lower in the Gastric Group 73 Kcal (92-288) vs 167 Kcal (70-411) in the Post-pyloric Group.
2. How precise was the estimate of the treatment effect?
	See 95% confidence intervals above.
Will the Results Help Me In Caring For My Patients?
1. Can the results be applied to my patient care?
	Yes, post-pyloric feeing is popular in many ICUs in Australia and New Zealand.
2. Were all clinically important outcomes considered?
	This trial does not allow us to establish if long term outcomes i.e. quality of life or physical function are improved based on route of feeding.
3. Are the likely treatment benefits worth the potential harms and costs?
	Whilst the time to initiate feeding and reach feeding goals was faster in the gastric group in this trial, readers must consider that there was no benefit in clinically important outcomes in LOS or ventilator days between groups and there is a trend (P=0.06) towards higher mortality in the post-pyloric group.
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