Clinical trial NCT04110613: RCT: Early Feeding After PEG Placement
Official title: A Randomized Controlled Trial to Reduce Periprocedural Fasting in Ventilated Trauma and Surgical Intensive Care Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Critical Illness
Malnutrition
Gastrostomy
Procedural Sequelae
Trauma
Surgery
Mechanical Ventilation
Lead sponsor: Carilion Clinic
Sponsor class: OTHER
Collaborators: name: Virginia Polytechnic Institute and State University
First posted: 2019-10-01
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Once scheduled for the bedside PEG procedure, patients will be randomized to either the experimental NoFAST group or the control FAST group.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Adult subjects over 18 years of age
* Negative pregnancy test for women participants of child-bearing age
* Mechanically ventilated surgical and trauma patients with clinical indication for PEG tube placement
* Tolerating tube feeds at goal prior to procedure

Exclusion Criteria:

* Patients with aberant gastrointestinal anatomy
* Patients with gastrointestinal motility disorders
* Patients with feeding intolerance prior to PEG tube procedure
* Pregnant women, children, or other vulnerable populations
* Clinical contraindications for PEG tube placement
* PEG performed in setting other than ICU at bedside

Primary outcomes:
measure: Hours fasted
timeFrame: 24 hours before to 72 hours after the procedure
Secondary outcomes:
measure: Complications
timeFrame: 0-72 hours after the procedure
measure: Calorie deficit
timeFrame: 24 hours to 72 hours after procedure
Other outcomes:
Locations:
city: Roanoke
country: United States
facility: Carilion Roanoke Memorial Hospital
state: Virginia
Study officials:
affiliation: Carilion Clinic, Virginia Tech Carilion School of Medicine
name: Katie L Bower, MD
role: PRINCIPAL_INVESTIGATOR
References:
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