Carilion Roanoke Memorial Hospital
Roanoke, Virginia, 24014, United States
Location status: Recruiting
Location contact
Jordan Darden, PhD
CONTACT
Michelle Rothrock
CONTACT
NCT Number: NCT04110613
Randomized controlled trial to establish evidence on which to base timing of enteral feeding after bedside PEG placement in ventilated Trauma and Surgical ICU patients.
Interested in participating?
Request Info18 year–100 year
All sexes
Interventional
Not applicable
Roanoke, Virginia, 24014, United States
Location status: Recruiting
Jordan Darden, PhD
CONTACT
Michelle Rothrock
CONTACT
Trauma and surgical intensive care unit(TSICU) patients supported with mechanical ventilation are at high risk for complications associated with malnutrition (Ambrosino and Clini 2004; Aubier et al. 1985; Hill et al. 1998). To mitigate this risk, therapeutic enteral nutrition(EN) is delivered via nasogastric(NGT), orogastric(OGT), or nasoenteric tube(NET) as soon as possible after admission to the intensive care unit(ICU) or upon restoration of gastrointestinal(GI) continuity. Despite these interventions, TSICU patients often suffer a calorie deficit associated with enteral nutrition interruption(ENI) for procedures or transitions in care(Peev et al. 2015; McClave et al. 2009). These periods of fasting predict quantified caloric deficit associated with complications of malnutrition(Peev et al. 2015; Segaran, Barker, and Hartle 2016). Reduction in ENI duration before and after ICU procedures has yielded decreased caloric deficits within mixed ICU populations(Segaran, Barker, and Hartle 2016).
When the need for EN is prolonged, percutaneous endoscopic gastrostomy tube(PEG) placement is a bedside procedure employed to promote progress toward rehabilitation and disposition out of the ICU. First described in 1980, the technique found its success in replacing the classic open gastrostomy performed through a laparotomy incision under general anesthesia(Gauderer, Ponsky, and Izant 1980). Approximately 100,000-125,000 PEGs are performed annually in the United States(Mendiratta et al. 2012). Despite 40 years of experience and its routine nature in modern critical care settings, there is little evidence on which to base timing of tube feeds after PEG placement in the mechanically ventilated Trauma and Surgical ICU(TSICU) population.
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. There is no evidence to support prolonged fasting after PEG placement in TSICU patients, thus an opportunity to improve patient outcomes by providing evidence that will encourage earlier feeding and a reduction in calorie deficits.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.
Trauma and Surgical ICU patients undergoing bedside PEG tube placement will be randomized to one of two groups: FAST and noFAST. The FAST group will have post-PEG tube feeds initiated 4 hours after the procedure. The noFAST group will have post-PEG tube feeds initiated <1 hour after the procedure. Feeds for both are to be initiated at the rate and with the formula the patient was tolerating prior to the procedure.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Earliest possible initiation of tube feeding after bedside PEG tube procedure.
Time frame: 24 hours before to 72 hours after the procedure
Number of hours patients are not receiving prescribed caloric intake
Time frame: 0-72 hours after the procedure
Complications associated with timing to start tube feeds after bedside PEG placement
Time frame: 24 hours to 72 hours after procedure
Cumulative calorie deficit acquired as a result of peri-procedural fasting
Contact information is provided by the study sponsor or research team.
Jordan Darden, PhD
CONTACT
Katie L. Bower, MD
CONTACT
Carilion Clinic
Other
A Randomized Controlled Trial to Reduce Periprocedural Fasting in Ventilated Trauma and Surgical Intensive Care Patients
Acronym: PEG
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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