Trial to Reduce Periprocedural Fasting in Ventilated Trauma Patients

Summary

Participation Requirements

Description

With this randomized controlled trial, investiagtors seek to produce data in support of a periprocedural nutrition delivery protocol that results in reduced enteral nutrition interruption (ENI) for critically ill ventilated trauma and surgical intensive care(TSICU) patients. Periprocedural fasting i...

With this randomized controlled trial, investiagtors seek to produce data in support of a periprocedural nutrition delivery protocol that results in reduced enteral nutrition interruption (ENI) for critically ill ventilated trauma and surgical intensive care(TSICU) patients. Periprocedural fasting is a frequent culprit of nutrition delivery deficits for this patient population, and percutaneous endoscopic gastrostomy(PEG) tube placement is a common procedure performed at the bedside. Pre- and post-PEG tube placement fasting practices are highly variable among surgical intensivists. There is no standard of care, despite truncated periods of periprocedural fasting described as safe in previously published retrospective and prospective observational studies. The aim of the study is to encourage a standard of care among surgical intensivists that will help to mitigate the risk of malnutrition in this highly susceptible patient population. This study will evaluate the effects of implementing an evidence-based truncated fasting protocol for ventilated trauma and surgical intensive care unit patients undergoing the PEG procedure. For clinically indicated reasons, these patients are maintained in a sedated state and supported by a ventilator via a cuffed endotracheal tube. They typically have an orogastric, nasogastric, or nasoduodenal (Dobhoff) feeding tube in place, and have demonstrated tolerance to enteral nutrition delivery prior to being scheduled for clinically indicated PEG tube placement. If they have a nasoduodenal feeding tube, they typically also have a naso- or orogastric tube in place for simultaneous gastric decompression while being fed in the postpyloric intestine. Once scheduled for the PEG procedure, patients will be randomized to either the experimental NoFAST group or the control FAST group. The NoFAST group will undergo naso- or orogastrointestinal tube feeding until 1 hour before the scheduled PEG procedure if the stomach is receiving EN, or until procedural timeout if the post-pyloric intestine is receiving EN. At the time tube feeding is stopped for the procedure, stomach contents will be aspirated by an oro- or nasogastric tube. The procedure will be carried out per standard clinical practice. At completion of the procedure, tube feeding will be resumed at the preprocedure rate. The FAST group will have naso- or orogastrointestinal feeding held at least 8 hours prior to the procedure, then for 4 hours after the procedure. Tube feeding will be resumed and titrated at the appointed time per standard CRMH clinical protocol for initiating tube feeding. All other procedures including PEG placement and feeding procedure will be completed to the standard of care for both groups. The patients will be monitored for hours fasted and calories delivered before and after the procedure, beginning 24 hours before the procedure until 24 hours after the procedure. Complications potentially attributable to the delivery of enteral nutrition, including feeding intolerance, will be monitored for 24 hours before until 72 hours after the procedure. Clinical postoperative monitoring will continue per standard of care for a minimum of six weeks.

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