None listed
Conditions
Brief summary
The purpose of this pilot study is to is to evaluate and assess a revised enteral nutrition protocol to deliver prescribed volumes of nutritional formula through a cyclic (also known as intermittent) 20-hour continuous method .The current enteral nutrition protocol is based on a 24- hour continuous cycle to deliver prescribed volumes of formula. However, various planned processes and events (such as fasting for endotracheal extubation) often interrupt a 24 hour continuous cycle of feeding potentially resulting in sub-optimal levels of nutrition delivery. Hence, the 20 hour continuous method (with a higher rate of feeding per hour) has been developed so that adequate nutrition can be delivered and planned interruptions can take place within the 4 hour non-feeding “gap” period. a minimum of forty patients will be enrolled from the Monash Medical Centre Intensive Care Unit and will be randomly allocated to a control group ( current 24 hour enteral feeding protocol) or an intervention group (revised 20 hour enteral feeding protocol). Data relating to nutritional and clinical outcomes will be collected for up to 12 days for each participant. The hypotheses is that the new protocol will safely and effectively improve current levels of nutritional adequacy from 48 % (based on local audit) closer to the optimal levels recommended in the literature ( > 80 %) We postulate that this increased provision of calories and protein may translate into improved nutritional and clinical outcomes, but the current study is not powered to demonstrate such a difference.
Interventions
Intervention group (20 hour protocol) participants will receive prescribed amounts of enteral nutrition following a revised protocol that includes compensatory increase in feeding rates over a set period of 20 hours a day and then fasted for a set period of 4-hours each day.
The prescribed amount given is based on the individual's nutritional assessment and estimation of of the energy and protein requirements . These requirements are calculated using predictive equations as is the common pr
Intervention group (20 hour protocol) participants will receive prescribed amounts of enteral nutrition following a revised protocol that includes compensatory increase in feeding rates over a set period of 20 hours a day and then fasted for a set period of 4-hours each day. The prescribed amount given is based on the individual's nutritional assessment and estimation of of the energy and protein requirements . These requirements are calculated using predictive equations as is the common practice by dietitians The overall duration is a maximum of 12 days or till patient is discharged from the ICU whichever is sooner. The 20 hour feeding protocol (Intervention group) involves running the prescribed amount for each patient as a continuous infusion for 20 hours per day followed by 4 hours of fasting Example : If a patient's requirements are 1800 calories and the amount prescribed is 1800 ml formula over 24 hours , the infusion will run at a rate of 90 ml /hour (90 ml x 20 = 1800 ml per day)
Sponsors
Monash Medical Centre
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adult patients (>18 years), expected length of stay (LOS) > 72 hrs; mechanically ventilated within 48 hours of admission to the ICU and indicated for enteral nutrition (presence and accessibility of functioning gut and inability to use the oral route for nutrition)
Exclusion criteria
Contraindicated for enteral nutrition for the first 72 hrs of ICU admission (inaccessible or non-functioning gastro-intestinal tract) ; patients on other forms of nutrition support ( oral or parenteral ) either exclusively or in combination with EN, discharged from the ICU less than 72 hours of ICU admission, moribund patients not expected to survive, patients who are not intubated or who receive mask ventilation ,
Outcome results
None listed