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The Impact of Enteral Feeding Protocols on Enteral Nutrition Delivery: Results of a multicenter observational study

Rupinder Dhaliwal, RD Daren K. Heyland, MD Naomi E Cahill, RD Xiaoqun Sun, MSc Andrew G Day, MSc Stephen A. McClave, MD

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Background

 Feeding protocols are considered to be an effective strategy to maximize the benefits and minimize the risks of enteral nutrition in critically ill patients.  Components of feeding protocols may include orders for      Early initiation of enteral nutrition Use of motility agents Gastric residual volumes Head of the bed elevation Use of small bowel feeding tubes  The benefits of such protocols would be:  to standardize the delivery of EN  to automate the provision of EN

What do Guidelines say?

“Use of a feeding protocol that incorporates motility agents and small bowel feeding tubes

should be considered

” 1 “Use of enteral feeding protocols increases the overall percentage of goal calories provided and should be implemented”.

Grade: C

“Evaluating gastric residual volume (GRV) in critically ill patients is an optional part of a monitoring plan to assess tolerance of EN. “

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RCT Level of Evidence

  

RCTs of aggressive feeding protocols

Results in better protein-energy intake Associated with reduced complications and improved survival Taylor et al Crit Care Med 1999; Martin CMAJ 2004; Doig GS JAMA 2008

However, the estimates of their effectiveness are limited due to:

 the nature of small single-center studies  the bundling with many other interventions in cluster randomized controlled trials.

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Purpose

To evaluate the effect of an ICU site-based feeding protocol on nutrition practices and outcomes in the context of an international multicenter, observational study. To compare the following performance criteria between sites that did or did not use a feeding protocol:  Use of EN  Time to start EN  Adequacy of enteral nutrition (EN % calories received/prescribed)  Adequacy of overall nutrition

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Methods

Data from two international, prospectively, observational cohort studies conducted in 2007 and 2008 from 269 ICUs across 28 countries were combined.

  Patients: Consecutively enrolled mechanically ventilated adults In ICU > 3 days      Data was collected from ICU admission to a maximum of 12 days: sites recorded the presence or absence of a feeding protocol type and amount of nutrition received strategies utilized to improve nutrition delivery 60 day mortality, hospital and ICU length of stay and duration of mechanical ventilation Each participating ICU aimed to recruit 20 patients.

Nutrition practices and clinical outcomes were compared between ICUs that used a feeding protocol and those who did not.

Data Management

Data entered on to our secure online edcs, built-ip range checks and data query process.

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www.criticalcarenutrition.com

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Primary Outcomes

Objective

To compare nutritional practices and outcome variables between ICUs with and without bedside feeding protocols.

Outcomes

Overall nutritional adequacy Enteral nutrition adequacy

Overall nutritional adequacy = as the total amount of calories or protein received (from either EN or PN plus propofol)/prescribed x 100%

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Data Analysis

Data from 2007 and 2008 combined, 334 total sites, 65 sites participated both years, 269 unique ICUs Hospital and ICU characteristics compared at the site level All other variables were compared at the patient level Clustered 2 stage sample design: patient and site, so potential for heterogeneity between ICUs. Advanced statistical methods were done to account for heterogeneity.

Results: Site Characteristics

Table 1.

Protocol (n=208) (77%) Hospital Type

Teaching Non Teaching

Size hospital

mean (range)

ICU structure

Open Closed Other

Medical Director Case Types

Medical Surgical Other

Size ICU Presence of ICU Dietitian FTE RD per 10 beds

Avg. # eligible patients contributed/year 162 (77.9%) 46 (22.1%) 606 (108-2502) 48 (23.1%) 156 (75.0%) 4 (1.9%) 196 (94.2%) 189 (20.6%) 191 (20.8%) 537 (58.6%) 17 (4-75) 168 (80.8%) 0.4 (0.0-6.7) 17.0 (range: 1-24)

No Protocol (n=61) (23%)

51 (83.6%) 10 (16.3%) 791 (138-4000) 22 (36.1%) 39 (63.9%) 0 (0%) 54 (88.5%) 44 (19.1%) 49 (21.3%) 137 (59.6%) 19 (5-48) 46 (75.4%) 0.3 (0.0-1.0) 14.6 (range: 1-25)

P value

0.38

0.004

0.099

0.15

0.0004

0.017

NR 0.50

0.37

0.42

p=0.001

Results

269 ICUs participated from 28 countries with 5497 patients

Canada 46/57 (80.7%) Ireland 7/7 (100%) USA 48/77 (62.3%) UK 19/19 (100%) Italy 7/7 (100%) India 5/9 (55.5%) Brazil 2/4 (50%) Australia 28/28 (100%) China 16/25 (64%) 29/61 (48%) of the non-protocolized sites being from the United States. New Zealand 6/7 (85.7%)

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Results: Feeding Protocols Characteristics Feeding Protocol Total n=269

Yes 208 (78%) 15.2% using the recommended threshold volume of 250 ml

Gastric Residual Volume Tolerated in Protocol

Mean (range) 213 ml (50, 500)

Elements included in Protocol

HOB Elevation 71.2 % Motility agents 68.5% Small bowel feeding 55.2%

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Results: Patients

Table 2.

Number of Patients

age Gender

Protocol n=4416

59.6 (12-96) 1771 (40.1%)

No Protocol n=1081

58.8 (15-99) 380 (35.2%) Admission category Medical Surgical APACHE II Presence of ARDS Mechanical Ventilation median (IQR) Hospital LOS Mortality 60 day 2792 (63.2%) 1624 (36.7%) 22.4 (1-72) 554 (12.5%) 8 (4-16.2) 21.9 (12.9-36.0) 1280 (29.0%) 633 (58.6%) 448 (41.4%) 21.9 (1-46) 137 (12.7%) 7 (3.6-14) 20.7 (12.6-32.0) 295 (27.3%) Heyland JPEN 2010 ( in press)

P value

0.38

0.13

0.30 0.31

0.96

0.089

0.25

0.37

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Results: Nutrition outcomes

Table 3.

Number of Sites EN alone PN EN + PN None

Protocol

208/269 (77%) 3108 (70.4%) 322 (7.3%) 785 (17.8%) 201 (4.6%)

No Protocol

61/269 (23%) 688 (63.6% ) 116 (10.7%) 184 (17.0%) 93 (8.6%)

P value

0.0036

Time to start of EN from ICU admission motility agents use in high GRVs average head of bead elevation 41.2 hrs 811 (64.3%) patients 32.5

o small bowel feeding in high GRVs 177 (14.0 %) patients 57.1 hrs 103 (49.0%) patients 30.0

o 35 (16.7%) patients 0.0003

0.0028

0.017

0.45

Heyland JPEN 2010 ( in press)

Results: Nutrition Adequacy

1 Adequacy from EN Overall nutritional adequacy

Protocol

45.4% 61.2 %

No Protocol

34.7%, 51.7%, Heyland JPEN 2010 ( in press) p<0.0001

p=0.0003

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EN adequacy: multilevel model

To control for the effect of significant patient and site level characteristics of EN adequacy

The expected average EN adequacy over the first 12 ICU days

Unadjusted

by 7.4% (SE=1.8%, p<0.0001) in patients from sites with protocols Adjusted

by 4.1% (SE=1.8%, p=0.021) in patients at sites with protocols

Heyland JPEN 2010 ( in press)

Conclusions

 There is great variation in the use of feeding protocols in ICUs across the World.  The presence of an enteral feeding protocol is associated with significant improvements in the use of EN, timing of initiation of EN, nutrition adequacy delivered, and the use of motility agents. 1  We suggest that the use of feeding protocols become standard of care in ICUs.  Despite the use of protocols, overall nutrition adequacy is still below target, further refinement and optimization of the characteristics of feeding protocols is warranted.

 The positive effect of feeding protocols on clinical outcomes is yet to be established. Heyland JPEN 2010 ( in press)

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Strengths and Weaknesses

Strengths

 large number of participating sites from around the world  Use of a structured, validated data capture system, which enhances the generalizability and validity of the observations.

Weaknesses

   observational nature of the study design did not standardize the specific nutrition interventions included in the feeding protocols did not optimize the utilization of protocols at each site. We are unable to comment on the quality of these existing protocols or the level of compliance at the bed-side.

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Acknowledgements

 The authors are grateful to the critical care practitioners from all participating ICU sites for their dedication and commitment to collecting data for this study.

 Naomi Cahill currently holds a Canadian Institutes for Health Research (CIHR) Fellowship in Knowledge Translation.

 All authors declare no conflicts of interest relevant to the subject of this manuscript.

Efficacy of Enhanced Protein-Energy Provision via the Enteral Route in Critically Ill Patients: The PEP uP Protocol A Single center feasibility trial